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Interventions
for Prevention & Treatment
Interventions for Prevention & Treatment
– Addressing tobacco control interventions to prevent tobacco
use and to treat tobacco addiction Over 80 studies were
identified that have bearing on development and testing
of interventions for
prevention of and treatment for tobacco use and its negative
health consequences.
Most of the research efforts are involved in development
and testing of interventions for treatment of smokers, particularly
pregnant smokers, while few studies appear to be focused
on smoking prevention. Interventions for Prevention of Smoking
and Related Health Risks Researchers at the University of
North Carolina Chapel Hill are testing the use of anti-smoking
socialization to prevent children from smoking in households
where parents smoke cigarettes.
An effort at Colorado State University is examining the
use of media campaigns to prevent rural 7th and 8th grade
Mexican American and White non-Hispanic students from smoking.
Information regarding the relationship between media exposure
and cigarette smoking among teenage girls was recently collected
by researchers at the University of Southern California.
This information will enable health professionals to design
more successful tobacco use prevention programs to reduce
media influences on female adolescents. Research is being
conducted to determine the developmental precursors to substance
use in girls. Some efforts are focused on gaining an understanding
of the health risks associated with smoking, e.g., cancer
and fetal developmental disorders.
This information can be used in educational information
aimed at prevention and treatment of smoking. Interventions
for Treatment of Smokers An effort at Louisiana State University
is aimed at determining what types of interventions will
be most successful in helping female students to quit smoking.
Several studies are examining sex, menstrual cycle, and
genetic influences on nicotine dependence and the ability
of individuals to quit smoking. This information will aid
in the development of more successful smoking cessation
interventions.
Information is being collected at the University of South
Carolina to develop pharmacological interventions for correcting
the behavioral problems associated with chronic tobacco
use. Bupropion use, cognitive-behavioral therapy, and group
therapy are being examined. Ongoing studies are testing
the effectiveness of nicotine replacement therapy.
One study examined the use of a nicotine patch to aid in
smoking abstinence, and similarly examined the efficacy
of the antidepressant fluoxetine. Other studies are comparing
the effectiveness of nicotine replacement therapy combined
with smoking cessation group therapy, and nicotine replacement
therapy combined with aerobic exercise. Several studies
are examining interventions that address postcessation weight
gain. Researchers at the University of Wisconsin recently
examined whether nicotine replacement therapy can help women
who are concerned over postcessation weight gain. Moderate
exercise with or without cognitive-behavioral smoking cessation
therapy is being tested at Miriam Hospital in Providence,
Rhode Island. Estrogen replacement therapy for postmenopausal
women is being examined for its ability to help minimize
weight gain and affect mood in women trying to quit smoking.
Exercise is being examined as a treatment for depressed
women attempting smoking cessation.
The Center for Health Studies in Seattle recently tested
the use of a motivational message from a pediatric health
care provider, self-help materials, and several follow-up
contacts to encourage mothers to quit smoking. Efforts are
being made to incorporate tobacco treatment interventions
into routine maternity case management and prenatal care
services.
Interventions for Cessation Treatment of Pregnant Smokers
A focus of a number of studies is to develop and test interventions
to aid in smoking cessation in pregnant mothers to prevent
infant morbidity and mortality. Several studies are focused
on gaining information that will aid in development of more
effective interventions for treatment of pregnant smokers.
Information is being collected at East Carolina University
on the relationship between maternal depressive symptoms
and other psychological factors and smoking cessation in
pregnancy. A study by the Sequoia Foundation collected information
on tobacco exposure levels during pregnancy. The Indigenous
Peoples Task Force is collecting information on patterns
of tobacco use among Minnesota’s pregnant American Indian
women.
A variety of interventions to promote smoking cessation
in pregnant women are being compared and tested. These interventions
include health education materials and programs, incentive
programs, motivational enhancement therapy, telephone counseling,
professional advice, nicotine replacement therapy, and bupropion
treatment. Other interventions include testing the use of
a reimbursement system for encouraging smoking cessation
in Medicaid recipients.
Research is being conducted at Duke University and the University
of Connecticut to determine the efficacy of nicotine replacement
therapy for treatment of pregnant smokers. At least three
studies are testing the use of motivational enhancement
therapy in reducing smoking during pregnancy. Researchers
at the University of Alabama, Massachusetts General Hospital,
the Kaiser Foundation, Duke University, and Brown University
are testing multiple interventions, including various types
of educational materials.
Interventions for Prevention of Smoking Relapse during Pregnancy
and Postpartum Several studies are focused on testing interventions
for smoking relapse prevention during pregnancy and postpartum.
Interventions being tested include bupropion treatment,
self-help using a handheld computer, telephone counseling,
motivational interviews, and educational booklets. Researchers
at the University of California and at Brigham and Women’s
Hospital are testing the use of bupropion for preventing
postpartum smoking relapse. Another effort is examining
the use of a self-help smoking relapse prevention intervention
using a small handheld computer that is individualized based
on state-of-the art ecological momentary assessment techniques.
An effort is ongoing to develop a series of cost-effective
Stay Quit booklets based on theory and research on smoking
relapse. A study at the University of Pittsburgh is collecting
information on the effects of mood and weight concerns on
postpartum smoking.
Other Related Activities Several activities besides research
studies that are contributing toward the development and
testing of interventions for prevention and treatment of
smoking include media campaigns, websites, and meetings.
A national telephone Quitline is being offered and tested
by the American Legacy Foundation. Several resources for
smokers interested in quitting are provided by the National
Women’s Health Information Center on the “A Breath of Fresh
Air” website. Topics discussed in the recent Annual Investigator
Meeting 2002,
Women and Smoking:
Smoking Has No Glass Ceiling, included prevention and cessation
strategies for women and girls and novel cessation approaches.
Title: Tobacco Cessation in Postmenopausal Women
Principal Investigator: Allen, Sharon S.
Institution: University of Minnesota Twin Cities, Minneapolis,
MN
Funding Agency: National Institute on Drug Abuse
Project ID: DA008075
Project Funding Period: 1 March 1993 – 31 July 2002
Abstract: In spite of the negative health effects of cigarette
smoking, if current trends continue, smoking rates for women
will surpass men by the year 2000. Studies show that women
have a greater fear of weight gain after quitting, as well
as, they tend to gain more weight to suggest gender specific
cessation strategies are needed. Animal and clinical studies
suggest that estrogen could decrease appetite behavior and
minimize weight gain, as well as, affect mood and therefore
could attenuate withdrawal symptoms. However, no study has
systematically and comprehensively investigated the different
effects of estrogen replacement therapy (ERT) in smoking
cessation in postmenopause where the estrogen level is low.
This renewal application will address this area in a randomized
double blind nontreatment study conducted in 2 parts over
4 years. Part I investigates if there is a differential
effect of ERT on appetitive behavior and withdrawal symptoms
in postmenopausal women during short term smoking cessation,
i.e., to decrease appetite behavior and minimize weight
gain, and affect mood and attenuate withdrawal symptoms.
Eligible subjects are randomized to smoking and non-smoking
status, and enter a 3- week period of scheduled measurements.
Week 1 is baseline with smoking ad lib, and in weeks 2 and
3 some subjects stop smoking while others continue smoking.
During these 3 weeks weight, caloric intake, RMR and tobacco
withdrawal symptom measurements will be done. Part II is
also a short term nontreatment study investigating the additive
effects of ERT on the same parameters in postmenopausal
women on nicotine replacement.
Subjects are randomized to ERT and placebo and monitored
for 1 month, then randomized to placebo or active patch.
The study design and measurements are identical to Part
I. The results of this research will increase our understanding
of the functional relationships between ERT and appetitive
behavior and withdrawal symptoms in smoking cessation in
postmenopausal women. This research will provide new information
which will be important and useful in assessing direction
for specific and more effective treatment strategies for
smoking cessation in women during the postmenopausal years.
Title: Sister to Sister: Helping Low-Income Women Quit Smoking
Principal Investigator: Andrews, Jeannette O.
Institution: University of South Carolina at Columbia, Columbia,
SC
Funding Agency: National Institute of Nursing Research
Project ID: NR008065
Project Funding Period: Not available
Abstract: Tobacco use is strongly linked to coronary heart
disease (CHD), the leading cause of death in women. African
American women of lower socioeconomic status are known to
have high smoking rates, disparities in smoking related
diseases, and difficulty with cessation. Despite these inequities,
sparse data exist describing effective interventions targeted
to this population. Although not evaluated in African American
women, research supports that intensive group tobacco cessation
interventions produce the highest quit rates (24 - 48 percent)
over self help (7 - 11 percent) and brief interventions
(13 - 16 percent) with other populations.
Social support and informal extended kin network, particularly
with lay health advisors (LHA), are beneficial in targeted
behavioral interventions to African American women for other
risk reduction measures such as breast cancer screening;
however this approach has not been effectively evaluated
with tobacco cessation. With further exploration and knowledge,
the investigator's goal is to develop and implement a nurse/LHA-managed
smoking cessation intervention tentatively entitled, Sister
To Sister: Helping Low-Income Women Quit Smoking.
The proposed intervention will target mediating variables
of social support, self-efficacy, and adaptive coping mechanisms
utilizing an intensive group intervention managed by a nurse
and LHA. A community advisory group consisting of informal
and formal community leaders will be formed to assist with
the recruitment and retention of LHAs. Community partnership(s)
with businesses, health agencies, churches, and other organizations
will provide a representative to the advisory group and
resources such as physical space and incentives for LHA.
A mid-range theory of self care behaviors in low-income
African American women will be developed to provide a framework
the study, and Prochaska's Transtheoretical Model of Change
will be used to guide the development and implementation
of the nurse/LHA intervention.
Title: Smoking Cessation in Mothers and Other Household
Members of Babies Being Treated
in a Special Care Nursery
Principal Investigator: Becker, Bruce
Institution: Rhode Island Hospital, Providence, RI
Funding Agency: Robert Wood Johnson Foundation
Project ID: 040671
Project Funding Period: 1 October 2000 – 30 September 2003
Abstract: The major goals of this project are to define
the natural
history of smoking and smoking cessation for mothers and
other household members of babies being treated in the Special
Care Nursery and to test a smoking cessation intervention
in this milieu.
Title: Designing a Provider Incentive System to Increase
Adherence to Maternity Tobacco
Cessation Guidelines
Principal Investigator: Bentz, Charles
Institution: Providence Health Systems, Oregon Region, Portland,
OR
Funding Agency: Robert Wood Johnson Foundation
Project ID: 043969
Project Funding Period: 1 December 2001 – 30 November 2003
Abstract: To significantly increase adherence with the 5
A’s Tobacco Cessation guidelines for pregnant smokers in
Oregon through development of a comprehensive reimbursement
system for obstetrical providers.
Objectives:
Develop a comprehensive reimbursement system for obstetrical
providers. Develop a strong implementation strategy for
the reimbursement system. Develop the capacity to conduct
future systems-level tobacco research by establishing relationships
between key Oregon entities engaged in maternity tobacco
cessation. This project will significantly advance the state
of the art of maternity tobacco cessation within Oregon.
Since Providence hospitals have the largest volume of deliveries
in
Oregon, this reimbursement system applied within Providence
has the potential to significantly decrease smoking rates
during pregnancy in this state.
The collaboration with Care Oregon will potentially extend
the reimbursement system to all Medicaid pregnant smokers
in Oregon, which could lead to significant reductions in
the Medicaid smoking rate. The comprehensive implementation
strategy will provide a compelling rationale for managed
care organizations (MCOs) to adopt the reimbursement system.
The implementation strategy will include a variety of tools
to assist MCOs in efficiently implementing the new reimbursement
system. Financial modeling is a key component of this strategy,
so that MCOs can easily predict the costs of implementing
the reimbursement system and can demonstrate the cost-effectiveness
of the system in achieving tobacco cessation among pregnant
smokers, including avoided negative outcomes for the baby.
The implementation strategy will also
include recommendations for reducing barriers to provider
adherence with 5 A’s guidelines, and materials that will
aid dissemination once reimbursement is adopted (e.g., suggestions
for clinicbsed training materials on implementing the 5
A’s with pregnant smokers, and information about how to
use the new
reimbursement billing codes). The statewide coalition developed
during this planning project will help direct the adoption
of the
reimbursement system by Oregon MCOs.
A successful working partnership will be established between
Providence, Care Oregon, the various Oregon agencies focusing
on maternity tobacco cessation (TOFCO and the Oregon Health
Division), and Oregon State University tobacco researchers
who are currently studying the efficacy of patient incentives
in maternity tobacco cessation. This partnership will enhance
future research opportunities by creating relationships
that encourage collaboration on additional shared research
goals beyond the reimbursement system.
Title: Mentored Investigator Award in Women's Health
Principal Investigator: Boardman, Lori A.
Institution: Women and Infants Hospital-Rhode Island, Providence,
RI
Funding Agency: National Institute of Child Health and Human
Development
Project ID: HD001307
Project Funding Period: 25 September 2001 – 31 August 2006
Abstract: The purpose of this award is to provide support
for Dr. Lori Boardman to pursue formal training in the fields
of biostatistics, epidemiology and public health, thereby
attaining the necessary theoretical and methodological background
to further a career in patient- oriented research.
The final three years of the award will be devoted to the
design, implementation, analysis of data and preparation
of the results of a randomized controlled trial of two smoking
cessation
interventions in a cohort of women referred for the evaluation
of abnormal Papanicolaou smears. The primary aims of this
study are to evaluate smoking cessation rates between the
two groups and to confirm self-reports of cessation through
measurement of cervical mucus cotinine.
The secondary aims are to determine the regression rate
of cervical neoplasia in women who quit smoking compared
to those who continue and to assess the independent and
combined contribution of human papillomavirus and smoking
on the natural history of atypical or low-grade cervical
neoplasia (includes cytology and/or histology). This trial
will be conducted with the guidance of a multidisciplinary
and experienced team including experienced women's health
and behavioral health researchers, epidemiologists, an oncologist,
and a statistician. Immediate Career Objectives: Pursue
formal training in research design and analysis by obtaining
a master's degree in public health; Improve abilities to
design, perform, analyze and communicate research findings
through the preparation of a master's thesis and formal
presentations of ongoing research stemming from clinical
work in cervical neoplasia; Implement and complete a randomized
trial of two smoking cessation interventions in women with
cervical neoplasia.
Lone-Term Career Objectives: Become an independent and productive
investigator in the field of women's health care; Secure
independent grant funding for patient-oriented research;
Become a leader in academic medicine and mentor more junior
investigators interested in women's health.
Title: Neurodevelopmental Basis(es) of Nicotine Sensitization
Principal Investigator: Booze, Rosemarie M.
Institution: University of South Carolina at Columbia, Columbia,
SC
Funding Agency: National Institute on Drug Abuse
Project ID: DA013712
Project Funding Period: 28 September 2002 – 30 June 2007
Abstract: Gender differences in response to psychostimulants
have been reported both in animals and humans; however,
the biological mechanisms which underlie these gender differences
to psychostimulants remain for the most part, unexplained.
The common observation is that females are more sensitive
to psychostimulants, such as nicotine.
Our hypothesis is: Gonadal hormones in adulthood and development
act on dopaminergic systems, providing the underlying basis
for the gender differences in behavioral sensitization produced
by repeated IV nicotine administration.
First, we will determine whether pharmacokinetic differences
between the sexes result in higher levels of nicotine in
the female brain. We have successfully developed a technically
simple, economical and practical non-tethered technique
for repeatedly
administering IV nicotine to freely moving, group-housed
rats. Detailed pharmacokinetic analysis has demonstrated
rapidly peaking nicotine levels following IV dosing in rats,
which is similar to that observed in humans, as opposed
to SC or PO dosing. Using this clinically relevant IV rodent
dosing model, we will determine whether pharmacokinetic
factors contribute to the increased sensitivity of female
animals to the effects of nicotine.
Second, we will determine whether gonadal hormones regulate
the expression of gender differences in response to nicotine
in adulthood. We will test the ability of gonadal hormones
to modulate dopamine receptor responsiveness to chronic
nicotine administration. Third, we will determine whether
the brain organizational (neurodevelopmental) effect of
the perinatal hormonal milieu mediates the gender differences
in nicotine responsiveness. We have pharmacologically characterized
a recently discovered unique dopamine receptor subtype (D3)
which is localized to the striatum/nucleus accumbens region
of the brain. We hypothesize that alterations in dopaminergic
systems underlie the gender differences produced by repeated
IV nicotine administration. Our long-term goal is to determine
the role of the dopamine neurochemical system in gender
differences following repeated IV nicotine administration.
The ultimate goal of this research is to develop pharmacological
interventions to assist in correcting the behavioral problems
associated with chronic tobacco use in humans, and specifically
to provide potential insight into effective gender-specific
treatment strategies for smoking cessation.
Title: TBA
Principal Investigator: Bowen, Margie
Institution: HealthPlus, New York, NY
Funding Agency: Not available
Project ID: Not available
Project Funding Period: Not available
Abstract: A mini-grant proposal has been accepted to develop
a prenatal smoking cessation incentive program for obstetric
providers affiliated with HealthPlus, a not-for-profit health
plan in New York City. Contract negotiations are still in
progress.
Title: Preventing Smoking Relapse During Pregnancy and Beyond
Principal Investigator: Brandon, Thomas H.
Institution: University of South Florida, Tampa, FL
Funding Agency: National Cancer Institute
Project ID: CA094256
Project Funding Period: 1 August 2002 – 31 July 2007
Abstract: The prenatal risks of tobacco smoking motivate
many women to quit smoking during pregnancy and to maintain
abstinence for several months. Unfortunately, the majority
of these women relapse to smoking either during their pregnancy
or within the first six months postpartum. Resumption of
smoking is associated with cancer and other health risks
to the smokers themselves and to those exposed to their
environmental tobacco smoke, including the infant and other
members of the family. Because so many women are able to
achieve at least short-term abstinence during their pregnancy,
the pregnancy and postpartum periods are collectively viewed
as a "window of opportunity for interventions designed
to prevent smoking relapse. Although modest success has
been achieved at aiding women in smoking cessation during
pregnancy, attempts to prevent subsequent smoking relapse
have been unsuccessful to date. The goal of Study I is to
develop the key materials for a cost-effective minimal intervention
preventing smoking relapse mongpregnant/postpartum women.
The intervention will be modeled after one developed by
the research team that has been found to reduce smoking
relapse by approximately two-thirds among a general population
of recent quitters. This intervention comprises a series
of eight Stay Quit booklets mailed to former smokers over
a year.
The booklets were developed based on theory and research
on smoking relapse, and were found to be extremely cost-effective.
However, because pregnant and postpartum women differ in
many ways from the general population of ex-smokers, it
cannot be assumed that the existing intervention would adequately
meet their unique needs. The end product of Study I will
be a series often Forever Free for Baby and Me booklets
designed to be provided to women between their sixth month
of pregnancy and eight months postpartum. The content of
the booklets will be based on three sources of information:
(1) the existing, validated Stay Quit booklets,
(2) theory and research on smoking relapse during and after
pregnancy, and
(3) systematic formative research comprising focus groups,
in-depth interviews, and learner verification interviews.
Subjects will include pregnant and postpartum women who
have maintained tobacco abstinence, as well as those who
have relapsed; their partners; and relevant health professionals
in the community. Study II will be a randomized, controlled
trial of the intervention developed in
Study I. Women who have quit smoking during pregnancy will
be recruited via childbirth education classes and randomly
assigned to receive the series of Forever Free booklets
versus a usual care control condition. Follow up will be
conducted through 12 months postpartum, and a format cost-effectiveness
analysis wilt be conducted. If shown to be effective, this
minimal intervention would be easy and inexpensive to disseminate
to women via a variety of channels and settings.
Title: Fetal Alcohol and Nicotine Induced Growth Retardation
Principal Investigator: Breese, Charles R.
Institution: Auburn University at Auburn, Auburn, AL
Funding Agency: National Institute on Alcohol Abuse and
Alcoholism
Project ID: AA011164
Project Funding Period: 21 Septembr 1998 – 31 August 2002
Abstract: Fetal alcohol syndrome is a constellation of birth
defects caused by maternal alcohol use during pregnancy,
and is characterized by intrauterine and postnatal growth
deficits, and CNS dysfunctions in the offspring. Tobacco
use during pregnancy is also an established cause of fetal
growth deficiency, although the toxicological effects of
prenatal nicotine exposure on the CNS are not clear. Since
tobacco use is highly correlated in women that abuse alcohol
during pregnancy, exposure to the combination of these substances
may exacerbate the deficiencies associated with alcohol
or tobacco use alone. While intrauterine and postnatal growth
deficiencies are the most common symptoms of fetal alcohol
or tobacco exposure, the cause of these deficiencies unknown.
Studies have shown a consistent long-term reduction of insulin-like
growth factor-1 (IGF-1), a major mediator of developmental
growth, in prenatally ethanol-exposed offspring. The goal
of this application is to investigate the actions of in
utero ethanol, nicotine, and ethanol/nicotine co-exposure,
on the regulation of the IGF and somatotropin gene families,
and assess the relationship of changes in tissue and brain
IGF and GH regulation, to that of the growth and CNS deficits
observed in these offspring.
The hypothesis is that fetal exposure to ethanol and nicotine
inhibits fetal and neonatal IGF-1 gene expression, thereby
reducing tissue availability to IGF-1, and causing or exacerbating
the observed growth deficits observed in these offspring.
The proposed studies to test this hypothesis include:
1) Examining the effect of fetal ethanol, nicotine and alcohol/nicotine
co-exposure, on plasma and somatic tissue specific IGF and
GH peptide and gene regulation;
2) Assessing the effect of fetal ethanol and nicotine exposure
and co-exposure on changes on CNS neurotrophic expression,
with particular emphasis on the IGF and neurotrophic gene
families;
3) Examining the specific actions of ethanol and nicotine
exposure on growth factor induced cellular function and
second messenger systems, in organ culture systems of affected
tissues; and
4) Assessing changes in gene expression by differential
display PCR, to identify additional candidate genes inthese
disorders. These studies will provide valuable data which
correlate with the endocrine and neuropathological changes
seen in fetal alcohol syndrome and smoking in human populations.
Title: Nursing Smoking Cessation Intervention During Pregnancy
Principal Investigator: Bullock, Linda F.
Institution: University of Missouri Columbia, Columbia,
MO
Funding Agency: National Institute of Nursing Research
Project ID: NR005313
Project Funding Period: 1 August 2001 – 30 April 2005
Abstract: Problems related to smoking during pregnancy are
entirely preventable. The imminent danger of smoking to
mothers (i.e. abruptio placentae) and unborn children (i.e.
low birthweight) calls for prompt and intensive intervention.
Reasons for continued smoking during pregnancy vary by age
and income. In this proposed study's low-income population,
the most likely group to
smoke throughout pregnancy, women suffer from stressful
events in their lives, which they cite as difficult barriers
to smoking cessation. Social support has been shown to be
beneficial in general for coping with problems. AHCPR smoking
guidelines call for a social support component in cessation
programs that is delivered by healthcare providers. Unfortunately,
the guidelines' recommendations for social support focus
narrowly on smoking related problems alone.
For low-income pregnant women, this tight focus means healthcare
providers may not touch on the very topics that are key
to their quitting smoking. Nurses' skills in assessment
and providing support are extremely well matched to delivering
the help women need to quit smoking during pregnancy. This
study's primary aim is to determine whether a combination
of an established smoking cessation educational program
for pregnant women and a nurse- delivered telephone social
support intervention (weekly telephone calls as well as
having 24-hour pager access to research nurses) will increase
pregnant womens' smoking cessation or smoking reduction
rates. A sample of pregnant women who smoke will be recruited
from WIC clinics in
central Missouri. The outcome measure will be saliva cotinine
values collected repeatedly every month from enrollment
in the study until the last month of pregnancy.
A secondary aim of the study will be to determine the prevalence
of relapse among the women who quit smoking, when the relapse
occurs, and associated stressors. A randomized controlled
trial of four groups will be conducted using a repeated
measures 2x2 factorial design with two levels of education
(Present or Absent) and two levels of nurse-delivered telephone
social support (Present or Absent). To determine significant
group differences in quit rates, Chi-square analysis for
each month will be used. A fixed-effects repeated measure
ANOVA will be used to determine significant group differences
in reduction in smoking and survival analysis will detect
if there are significant group differences in time to relapse.
Title: Smoke-Free Connections: Helping Pregnant Women Build
Support for Not Smoking
Principal Investigator: Carter Gaffney, Cecelia
Institution: Norris Cotton Cancer Center, Dartmouth Medical
School, Hanover, NH
Funding Agency: Robert Wood Johnson Foundation
Project ID: 040666
Project Funding Period: October 2000 – October 2002
Abstract: Determine whether home-based solution-focused
smoking cessation counseling when combined with clinic-based
best practice will increase the number of women who quit
or significantly reduce cigarette smoking during pregnancy.
Research Design: Feasibility study in two phases. Phase
one is
natural history study to determine smoking prevalence, natural
quit rates and levels of partner support with a Medicaid
population. Phase two is an intervention study using a pre-posttest
design to measure impact of combined clinic and home-based
counseling on smoking during pregnancy.
Study Population: Low-income pregnant women receiving care
through Medicaid-funded prenatal clinics in New Hampshire.
All women who present for prenatal care at participating
clinics who are currently smoking (a puff or more in the
past 7 days), <20 weeks gestation, and married or living
with a partner.
Intervention (if appropriate): All pregnant smokers will
receive a brief counseling session at the first clinic visit
based on best practice. A home visitor will provide two
home-based counseling sessions based on solution-focused
techniques. These sessions will be designed to increase
the pregnant smokers’ self-efficacy for quitting smoking,
increase her partners’ positive support for quitting smoking
and to reduce her exposure to environmental tobacco smoke.
Outcome Measures (If cessation or reduction, how defined):
Quit rate will be a ratio of a 7 day point prevalence smoking
rate in third trimester of pregnancy compared to 7 day point
prevalence smoking rate at intake. Women lost to follow-up
will be considered smokers. Validated with NicAlert test.
Number of cigarettes in past 7 days will be used to calculate
reduction in smoking, measured at intake and during third
trimester.
Title: Postpartum Smoking and Infant ETS Reduction Trial
Principal Investigator: Collins, Bradley H.
Institution: University of Pennsylvania, Philadelphia, PA
Funding Agency: National Cancer Institute
Project ID: CA093756
Project Funding Period: 27 March 2002 – 31 December 2006
Abstract: The purpose of this proposal is to build a mentored,
clinical research training experience to foster independent
professional development in cancer control research. This
application is being submitted from the University of Pennsylvania
Cancer Center, which provides a setting with excellent opportunities
to work with Dr. Caryn Lerman, the Transdisciplinary Tobacco
Use Research Center (TTURC), and my co-sponsors, Drs. Charles
O'Brien and J. Sanford Schwartz. Sound career development
in cancer control research requires broad exposure to research
methodologies and intensive research training in order to
make significant, independent contributions to this field.
Therefore, this K07 Career Development Award application
seeks to achieve these goals in the area of tobacco control
and maternal and child health.
General plans for the career development program
include:
(a) expanding working knowledge of areas relevant to cancer/tobacco
control research;
(b) refining skills in the application of behavioral science
to cancer/tobacco control;
(c) increasing knowledge of maternal health issues related
to cancer/tobacco control;
(d) expanding understanding of the biobehavioral mechanisms
of tobacco addiction;
(e) improving skills in designing, implementing, and analyzing
cancer/tobacco control interventions; and
(f) learning effective ways to disseminate research findings
to impact upon public health practices. Specifically, the
research project aims to develop a low-cost, primary-care
intervention to reduce children's Environmental Tobacco
Smoke exposure and maternal smoking rates targeting under-
served mothers with children ages 0-2. The effectiveness
of this intervention will be tested by comparing it with
a standard care control-group intervention using a two-group,
repeated measures randomized design. The intervention will
be modeled after more intensive, home-based counseling programs
the feasibility of which has been demonstrated. However,
as these interventions were labor intensive and costly,
the proposed intervention presents an innovative, comprehensive,
albeit streamlined primary-care approach to an emerging
issue in the tobacco control field. This intervention will
also set the groundwork for an eventual R01 that will test
the treatment and prevention efficacy of this intervention
on other populations (e.g., adolescent smokers and their
younger, nonsmoking siblings).
Title: The Alabama Tobacco Free Families Program
Principal Investigator: Crawford, Myra
Institution: University of Alabama at Birmingham, Birmingham,
AL
Funding Agency: National Cancer Institute
Project ID: CA86311
Project Funding Period: 4 August 2000 – 30 June 2004
Abstract: The objective of the Alabama Tobacco Free Families
(ATOFF) Program, a multi-component, multi-channel health
communications and policy change program, is to reduce the
smoking prevalence rate among a representative sample of
pregnant females whose maternity care is supported by Medicaid.
This will be achieved by reducing the rate of females of
childbearing age in eight targeted counties by changes in
social norms. The proposed study is an extension of two
decades of public health education studies conducted by
the University of Alabama at Birmingham (UAB) tobacco research
team in partnership with the ADPH's Bureau of Family Health
Services (BFHS). ATOFF will expand this partnership to include
the ADPH Bureau of Health Promotion and Information. It
is designed to enhance the capacity of the state's Tobacco
Use Prevention and Control Program (TUPC), funded by CDC
in 1999. UAB and
ADPH will implement statewide and local partnerships targeting
females of childbearing age to be tobacco-free prior to
and during pregnancy. ATOFF will be evaluated using a time
series design and analysis with multiple, quarterly baseline
and follow-up measures of prevalence across the eight targeted
counties. Process and behavioral impact evaluations will
be conducted.
The four specific aims to be accomplished by the proposed
study will be to
1.) Identify and select a representative sample of patients
from a randomly selected sample of Medicaid-supported maternity
care sites to serve as the ATOFF clinic population, and
to recruit a representative sample of females (14-44) to
participate in a telephone-based survey to serve as the
ATOFF community cohort;
2.) Develop and implement a multi-component, multi-channel
program focused on females of childbearing age and their
families in eight target counties and consisting of
(a) a mass media-health communications component,
(b) a community organization component, and
(c) a professional practice component;
3.) Document the implementation success (process evaluation)
of the media messages and community initiatives to change
beliefs, behaviors, and social norms related to tobacco
use among the samples of females in Aim number 1 by conducting
clinical and community assessments in Years 01, 02, 03 and
04; and 4 Document, be self-reports and saliva continine
tests, the effectiveness (impact evaluation) of ATOFF's
program to reduce the prevalence among the clinic population
at entry (first visit) into Medicaid maternity care, and
by self-report via telephone of the females in the community
population.
Title: A Computer-Based System of Adopting 5 A Guidelines
into Obstetrical Practice
Principal Investigator: Cristiano, Lynda
Institution: Brigham and Women’s Hospital, Boston, MA
Funding Agency: Not available
Project ID: Not available
Project Funding Period: Not available
Abstract: A mini-grant proposal has been accepted to incorporate
a tobacco treatment reminder system into the electronic
medical record used by the OB/GYN Department of Brigham
and Women’s Hospital. Contract negotiations are still in
progress.
Title: Smoking Research with Incarcerated Females
Principal Investigator: Cropsey, Karen L.
Institution: Virginia Commonwealth University, Richmond,
VA
Funding Agency: National Institute on Drug Abuse
Project ID: DA015774
Project Funding Period: 30 September 2002 – 31 August 2007
Abstract: The purpose of this application for a 5-year Mentored
Patient-Oriented Research Career Development Award (K23)
on smoking among incarcerated females is to conduct research
and training activities to advance the candidate's development
as an independent clinical researcher. This includes formal
classwork pertaining to research design, biostatistics,
and ethics along with conference attendance and meetings
with mentors. The proposed research plan includes two studies
that build upon each other in the area of smoking among
female prisoners. The first study is cross-sectional and
is designed to investigate the smoking behavior of incarcerated
females. In addition, this study will examine differences
between smokers, ex-smokers, and non-smokers on measures
of substance abuse and personality, with consideration to
other key covariables such as criminal history, medical
problems, readiness to change, and Axis I pathology as possibly
differentiating between the three groups.
The second study will be a clinical trial using Hall et
al. 's (1994) Mood Management group smoking cessation intervention
combined with nicotine patch (or no patch). The intervention
group will be compared to a wait-list control group who
will receive the treatment six months later. It is expected
that women who successfully complete the intervention will
have higher smoking cessation rates than wait-list controls.
Further, it is hypothesized that women with substance abuse
and psychiatric comorbidity will have poorer outcomes than
those without comorbidity. These projects should add significant
information to the literature which is currently devoid
of research related to smoking and female prisoners. This
is particularly relevant now as it has been shown that women
may have more difficulty with quitting smoking than men
and may also have additional concerns related to smoking
(e.g., smoking as weight management) that influence their
success. Testing effective smoking cessation interventions
with this underserved and understudied population is urgently
needed as the medical costs associated with treating prisoners
currently accounts for 11% of the Department of Corrections'
budget and is expected to double over the next 10 years.
Overall, these projects will provide experiences necessary
for the candidate to develop an independent research program
focusing on effective smoking interventions for incarcerated
individuals.
Title: Pediatric Smoking Cessation Study
Principal Investigator: Curry, Susan J.
Institution: Center for Health Studies, Seattle, WA
Funding Agency: National Heart, Lung, and Blood Institute
Project ID: HL056772
Project Funding Period: 1 July 1997 – 30 June 2001
Abstract: In this revised application the investigators
propose to recruit 500 female smokers from two low-income
urban pediatric clinics. The first aim of the study is to
conduct a randomized trial comparing usual care to a smoking
cessation intervention consisting of a brief motivational
message from a pediatric health care provider; self-help
materials developed specifically for low literacy, low income
populations; a 10 to 15 minute motivational interview with
a specially-trained nurse at the pediatric clinic; and three
personal follow-up contacts.
The primary endpoint is smoking prevalence at a 12 month
follow-up. Secondary endpoints include use of the self-help
materials, serious quit attempts, and short and long-term
abstinence. A second aim is to conduct a prospective, longitudinal
assessment of factors associated with smoking cessation
in the target population. For this aim, at baseline and
at three and 12 months, a variety of process variables are
to be measured, including knowledge and attitudes about
smoking and health, expectations and concerns about weight
and weight gain following smoking cessation, motivation
regarding smoking cessation, alcohol and other drug use,
stress, depression, partner and household-member smoking
status, and health events of the child. The investigators
plan to examine the degree to which these variables predict
changes in smoking status, whether time-related changes
in these variables are associated with change in smoking
status, and the extent to which these variables moderate
the intervention effects.
Title: Reducing Tobacco Abuse Among Pregnant American Indian
Women
Principal Investigator: Day, Sharon
Institution: Indigenous Peoples Task Force, Minneapolis,
MN
Funding Agency: Minnesota Partnership for Action Against
Tobacco
Project ID: Not available
Project Funding Period: 1 May 2002 – 30 April 2004
Abstract: The Indigenous Peoples Task Force (IPTF) requests
funds to conduct participatory action research with our
community in Minnesota. The goal of this project is to deepen
our understanding of why and how American Indian women smoke
during pregnancy, to use the action research process to
build community readiness to address this issue, and then
to use our
critical inquiry to create intervention ideas to support
and nurture
pregnant women to reduce their commercial tobacco use and
exposure to secondhand smoke.
How research fits funding priorities. This action research
addresses the MPAAT priority funding areas
1) reduce tobacco (ab) use among communities of color and
2) reduce exposure to secondhand smoke. Rationale, Design
and Analysis Plan. To date, no research has been conducted
to investigate patterns of tobacco use among Minnesota's
pregnant American Indian women or effective culturally relevant
programs to help them quit. While Minnesota's birth certificate
data have not been published, our preliminary analysis of
these data revealed alarmingly high prevalence of 40% smoking
among pregnant American Indian women compared to 13% among
European American women. We proposed a 3 stage participatory
action research project: The first phase, "Learning,"
includes development of a community research team, then
compilation and review of secondary data including underutilized
data sets. We will develop a research plan with the community
research team and train community researchers to collect
data. The second phase of research will be "Listening."
We will collaborate with community
agencies to find participants.
We will use creative, culturally appropriate data collection
techniques, such as oral histories, talking circles, and
Photovoice sessions with pregnant women who smoke or who
have recently quit, and possibly elders, family members,
or others as determined by the team. The third phase of
research will be "Reflection and Sharing." The
community research team will use collaborative, creative
techniques to analyze the data, and then disseminate the
results through community networks, news media, and cultural
events. We will host a community feast/Vision Retreat to
bring Native and non-Native groups together to begin the
next phase of action--preparing an MPAAT intervention grant
to nurture and support pregnant women to quit smoking and
reduce exposure to secondhand smoke.
Title: Oregon Smoke-Free Mothers and Babies
Principal Investigator: Dodson, Donalda
Institution: Oregon Department of Human Resources, Salem,
OR
Funding Agency: Not available
Project ID: Not available
Project Funding Period: Not available
Abstract: The focus of the Oregon Smoke-Free Mothers and
Babies project is to decrease tobacco use among pregnant
women who are enrolled in Medicaid. Project staff are accomplishing
this goal by incorporating the “5 A’s” into the state-funded
maternity case management system, and by coordinating prenatal
smoking cessation services among case managers, prenatal
care providers, and the Oregon Quitline. The intervention
is taking place in ten pilot counties, where systems level
supports such as reminder
systems, standardized data collection forms, and a fax referral
system to the Oregon Quitline are being established. A quality
improvement approach that emphasizes data-driven changes
in the processes of care will help incorporate tobacco treatment
interventions into routine maternity case management and
prenatal care services.
Title: Biochemical Feedback and Benefits Expansion for Smoking
Cessation: Sustained
Treatments Over the Prenatal Period (STOPP)
Principal Investigator: Doescher, Mark
Institution: Not available
Funding Agency: Robert Wood Johnson Foundation
Project ID: 040664
Project Funding Period: October 2000 – September 2004
Abstract: Not available
Title: Maternal Interventions to Stop Smoking
Principal Investigator: Donatelle, Rebecca
Institution: Oregon State University, Corvallis, OR
Funding Agency: Robert Wood Johnson Foundation
Project ID: 040669
Project Funding Period: October 2000 eptember 2004
Abstract: Tobacco use is widely recognized as the single,
most important public health issue today, causing nearly
half a million deaths per year, over $50 billion in smoking-related
illnesses, and contributing significantly to the total US
burden of disease. The economic burden to Oregon from smoking,
based on 1996 data, is $1.5 billion. Of that, $800 million
is for medical expenditures (direct costs) and $700 million
is for loss of productivity due to illness or premature
death (indirect costs). Recent (1998) Oregon
Health Division data indicate that over 22% of Oregonians
smoke and that 82 of these smokers initiate their smoking
behavior before the age of 21. For Pregnant Smokers Smoking
has remained the single most important modifiable cause
of poor pregnancy outcome in the USA. Smoking accounts for
20% of low birth weight deliveries, 8% of preterm births,
and 5% of all perinatal deaths, contributes to Sudden Infant
Death Syndrome (SIDS) and may cause important changes in
fetal brain and nervous system development. In the US quitting
smoking can prevent 40,000 low-birthweight (small for age)
babies and can prevent 4,600 perinatal deaths (estimated
cost of $69,542 for each perinatal death).
New economic estimates indicate that the direct medical
costs of a complicated birth for a smoker are 66% higher
than for nonsmokers which reflects the intensive medical
care required. 28% of the high-risk, low-income, Oregon
Health Plan pregnant population smoke, as reported by Oregon
Health Division (1999 data). Study Design Four-year, randomized
controlled trial of a theory-based, motivational intervention
using patient incentives and clinic supports combined with
a core “best practice” intervention delivered by OB/GYN
practitioners. Purpose To significantly increase smoking
cessation behavior among low-income, high risk (Medicaid/Oregon
Health Plan eligible) pregnant women who access private
practice managed care prenatal clinics in heavily populated
areas of Oregon.
Expected Outcomes
(1) Establish whether incentives are more effective than
Best Practice in motivating smoking cessation/reduction,
(2) Examine feasibility of delivering the intervention in
managed care prenatal clinics on a national basis.
Title: Psychological Influences on Immune Responses to HPV
Principal Investigator: Fang, Carolyn
Institution: Fox Chase Cancer Center, Philadelphia, PA
Funding Agency: National Cancer Institute
Project ID: CA88307
Project Funding Period: 1 August 2000 – 31 July 2002
Abstract: The role of certain types of human papillomavirus
(HPV) in the etiology of cervical cancer is well-established.
However, the influence of psychosocial, behavioral and immunologic
factors on cancer risk and development needs further exploration.
The proposed project aims to elucidate the potential links
between psychological (e.g., distress, coping processes)
and behavioral (e.g., cigarette smoking) risk factors and
novel immunologic measures (e.g., T-cell proliferative responses
to HPV proteins) in women with mild dysplastic lesions of
the cervix due to infection with highly oncogenic subtypes
of HPV. Specifically,
the proposed project is designed to identify potential behavioral
and immunologic correlates of psychological distress and
coping, with a particular emphasis on the effects of avoidant
coping strategies on cancer risk and development. Sixty-two
women referred for a follow-up colposcopy will complete
baseline psychosocial assessments and provide a blood sample
(for immune assays) prior to their colposcopy. In addition,
HPV typing of cervicovaginal cells will be conducted at
baseline. Follow-up assessments will be conducted at 6-months
and 12-months post-baseline. Psychosocial assessments include
measures of psychological distress, cancer-specific intrusive
and avoidant ideation, and a variety of coping strategies.
Relevant immune measures include numbers and percentages
of circulating lymphocytes, as well as T-cell proliferative
responses to synthetic peptides derived from HPV 16, a specific
marker of immunocompentence and one that has been shown
to be associated with viral clearance and cervical disease
regression.
In addition, medical outcome (regression, persistence, or
progression of cervical lesions), demographic variables,
and behavioral risk factors (e.g., smoking) will be assessed.
The identification of potential interrelations among psychosocial,
behavioral, and immunologic variables has important implications
for cancer prevention and control, as this information can
be used to guide the development of psychological and behavioral
interventions aimed at reducing distress and avoidance,
which may lead to improved behavioral, immunologic, and
health outcomes.
Title: Obesity Prevention After Smoking Cessation in Menopause
Principal Investigator: Geiselman, Paula J.
Institution: LSU Pennington Biomedical Research Center,
Baton Rouge, LA
Funding Agency: National Institute on Aging
Project ID: AG018239
Project Funding Period: 1 March 2000 – 28 February 2003
Abstract: The present proposal is an obesity prevention
pilot study that addresses the high risk of weight gain
associated with smoking cessation in postmenopausal women,
especially African Americans. This proposal is innovative
and unique in its analysis of at and other macronutrient
intake as a target for individually tailored, weight control
intervention following smoking cessation in women. This
treatment program is designed for the primary prevention
of weight gain that can lead to overweight in normal- weight
women, that can progress to obesity in women who are already
overweight (BMI=25.0-29.9), and for the prevention of additional
weight gain in obese women with BMI's greater than or equal
to 30.0. Postmenopausal African- American and Caucasian
women aged 45-59 years will undergo the same standard two-week
smoking cessation program followed by a 20-month, experimental
or control follow-up intervention.
Specific aim 1; To compare the relative effectiveness of
following an empirically
validated smoking cessation program with either
1) a group cessation maintenance program with standard exercise
advice and food pyramid instructions for healthy eating
or
2) a novel, individually tailored dietary-control and exercise,
weight-management and cessation program in Caucasian and
African-American postmenopausal women as assessed by weight
change frombaseline to post-cessation months 6, 12, and
20. It is hypothesized that our individually tailored, long-term,
experimental intervention will effectively control dietary
intake, particularly fat intake, thereby preventing weight
gain post-cessation.
Specific Aim 3: To assess whether there is differential
responsiveness on the above measures in postmenopausal Caucasian
versus African- American women. It is hypothesized that
African-American women may respond differently from Caucasian
women on the above measures. This pilot study is an extension
of our research program with the long-term objective of
developing individualized, multi-disciplinary, long-term
interventions for the prevention of weight gain following
smoking cessation in various subsets of women throughout
the American population.
Title: Smoke-Free Families: National Research Office
Principal Investigators: Goldenberg, Robert, and Klerman,
Lorraine
Institution: University of Alabama, Birmingham, Birmingham,
AL, and Brandeis University
Waltham, MA
Funding Agency: Not available
Project ID: Not available
Project Funding Period: Not available
Abstract: The aim of this program is to reduce rates of
smoking in families in the United States by supporting research
to develop and evaluate effective new interventions to help
women quit smoking before, during, and after pregnancy.
Pregnancy, and the periods immediately preceding and following
it, provide unique “teachable moments” to help women stop
smoking. Women are highly motivated to stop smoking during
these times, when they are concerned not only about their
own health, but also about the health of their infants.
Many women who do not otherwise seek or receive primary
care or preventive services can be reached during family
planning and prenatal care visits, with follow-up later
in hospitals, pediatric offices, health clinics, day care
programs, and during nursing visits to their homes. Providers
and health care systems have especially compelling reasons
to intervene during these periods given the many immediate
health benefits of quitting.
Title: Smoking Cessation to Reduce Cervical Cancer Risk
Principal Investigator: Greene, Paul
Institution: University of Alabama at Birmingham, Birmingham,
AL
Funding Agency: National Cancer Institute
Project ID: CA75455
Project Funding Period: 30 September 1997 – 30 June 2002
Abstract: Cervical cancer is a major source of morbidity
and mortality among women, with a particularly high burden
evidenced among women in Alabama. Although HPV has been
identified as the major causative agent for cervical cancer,
most women with HPV do not develop cervical neoplasia, suggesting
that progression to cervical cancer may be influenced by
other factors. Smoking has consistently been associated
with increased risk for cervical cancer, even among women
already at elevated risk due to cervical dysplasia and HPV
infection.
Further, available data suggest that smoking cessation may
decrease cervical cancer risk. These data justify a prospective,
controlled study, examining the efficacy of smoking cessation
in halting the progression of cervical dysplasia. The proposed
5-year clinical trial will evaluate the effect of a theory-based
smoking cessation intervention on progression from low-grade
squamous intraepithelial lesions (LSIL) to high-grade squamous
intraepithelial lesions (HSIL) in female smokers with HPV.
The plan is to recruit 220 current smokers ((10 cigarettes/day)
with oncogenic HPV from the University of Alabama at Birmingham
Colposcopy Clinic and randomly assign them to one of two
treatment conditions:
1)usual care (UC); or
2) smoking cessation intervention (SCI). Patients in both
groups will receive standard conservative management for
LSIL, biannual pap smears and more aggressive treatment,
as needed. Additionally, patients in the SCI group will
also participate in an
intensive smoking cessation intervention which will include:
1) cognitive-behavioral strategies to facilitate changes
in smoking behavior;
2) short-term nicotine replacement therapy to minimize discomfort
associated with nicotine withdrawal; and
3) a motivational intervention to promote the optimal use
of cognitive-behavioral strategies and nicotine replacement
therapy. The primary outcome will be rate of biopsy-confirmed
progression to HSIL over 18-month follow-up. The investigators
also propose to collect self-report and biochemical measures
of smoking status and dysplasia progression. Finally, perceptions
about cancer risk and cancer control practices will be assessed
to examine relationships with smoking cessation program
participation and changes in smoking.
Title: Efficacy of Motivational Enhancement and Physiologic
for Prenatal Smoking Cessation
Principal Investigator: Groff, Janet
Institution: Not available
Funding Agency: Robert Wood Johnson Foundation
Project ID: Not available
Project Funding Period: Not available
Abstract: This study proposes a randomized controlled trial
to test the addictive effects of fetal ultrasound and motivational
enhancement to best practice counseling for prenatal smoking
cessation in low-income women. Biochemical validation of
smoking will be measured at baseline, 34 weeks gestation,
and six weeks postpartum.
Title: Innovation to Prevent Post-Partum Relapse
Principal Investigator: Haas, Jennifer
Institution: University of California, San Francisco, CA
Funding Agency: California Tobacco-Related Disease Research
Program
Project ID: 9IT-0192
Project Funding Period: 1 July 2000 – 30 June 2002
Abstract: Cigarette smoking is the leading cause of preventable
morbidity and mortality for women in the United States.
Pregnancy is a pivotal event of young adulthood for many
women.
This is confirmed by the observation that women are much
more likely to quit smoking around the time of pregnancy
than at any other. Unfortunately, women who quit during
pregnancy have extremely high rates of relapse during the
months immediately following delivery.
There are several reasons why post-partum women are at high
risk of relapse including: decreased motivation, depression,
stress, sleep deprivation, and concerns about the loss of
weight gained
during pregnancy. Conversely, there are many reasons to
think that the perinatal period is an important opportunity
to influence a woman’s lifetime smoking behavior including:
parenthood and a growing sense of responsibility, more frequent
contact with the health care system, and less severe nicotine
cravings because a woman has already been smoke-free for
several months. Behavioral intervention during pregnancy
has not been associated with an increase in postpartum tobacco
abstinence.
Recent studies suggest that bupropion is effective therapy
for smoking cessation. There are several reasons that bupropion
may be an effective therapy to prevent relapse post-partum,
including mood stabilization, decreased fatigue, decreased
tobacco craving, and increased weight loss. To date, there
is no literature examining the use of bupropion or other
anti-depressants as part of an intervention to prevent post-partum
relapse. In the proposed IDEA Award program, we will conduct
a series of exploratory studies to examine the feasibility
of incorporating bupropion into an innovative treatment
program to prevent postpartum smoking relapse. The results
of this work will be used to design a randomized controlled
clinical trial to prevent post-partum smoking relapse that
will incorporate pharmacotherapy in addition to a behavioral
intervention. The proposed project will address the following
Specific
Aims: (1) To define an appropriate target population for
a pharmacologic intervention to prevent post-partum relapse
to tobacco use, we will quantify the amount of bupropion
in breastmilk of 20 women who are lactating but not breastfeeding.
The results of this Aim will determine whether it is safe
to administer bupropion to post-partum women who are still
breastfeeding or contemplating breastfeeding or whether
it is
necessary to wait until a woman is no longer breastfeeding.
(2) To inventory, categorize and evaluate behavioral smoking
cessation and relapse prevention interventions for pregnant
and post-partum women.
(3) To obtain explicit information about how best to target
a multi-faceted intervention to prevent post-partum smoking
relapse, we will conduct interviews with a multi-ethnic
sample of 50 women. Each woman will be surveyed twice: once
during pregnancy and the then again 6 – 8 weeks postpartum.
These surveys will examine:
(a) The prevalence and duration of breastfeeding among a
multi-ethnic sample of women who have quit smoking during
pregnancy.
(b) A woman’s perception of her risk of relapse.
(c) The acceptability of a pharmacologic intervention during
the post-partum period.
(d) The acceptability of a variety of behavioral interventions
(e.g., content, format, intensity) for these women and their
household members. Pregnancy is an important opportunity
in young adulthood to reduce a woman’s lifetime exposure
to tobacco. If women can be converted from pregnancy-quitters
to long-term quitters this would significantly reduce their
lifetime exposure to tobacco as well as reducing the exposure
of their
children to environmental tobacco smoke. The results of
the proposed research will lead directly to an innovative,
multifaceted, targeted intervention to prevent post-partum
relapse in a multi-
ethnic cohort of women.
Title: Partnership for Smoke-Free Families Program
Principal Investigator: Hartigan, Phyllis
Institution: Children’s Hospital and Health Center, San
Diego, CA
Funding Agency: Not available
Project ID: Not available
Project Funding Period: Not available
Abstract: In 1998, a trilateral partnership among three
large not-for-profit healthcare systems was formed in 1998
to promote smoking cessation services for women during the
preconceptional, prenatal, and post-partum periods. The
intervention is a standardized program consisting of tobacco
treatment resources, training, office support, and referrals
to the California Smokers Quitline. The Smoke-Free Families
mini-grant funds are being used to produce a technical assistance
manual with sample materials and recommendations for other
health care systems that want to implement similar activities.
Title: Smoking Cessation for Pregnant Substance-Dependent
Women
Principal Investigator: Haug, Nancy A.
Institution: University of Maryland Baltimore County, Catonsville,
MD
Funding Agency: National Institute on Drug Abuse
Project ID: DA05980
Project Funding Period: Not available
Abstract: Pregnant drug-dependent smokers are a subgroup
of substance abusers at especially high risk for health
complications. Due to documented deleterious effects of
drug use and smoking on both mother and neonate, effective
smoking cessation interventions are warranted. The proposed
research will systematically examine smoking topography,
attitudes, and behaviors among substance-dependent women.
The effectiveness of smoking cessation Motivational Enhancement
Therapy (MET) in increasing quit rates and reducing smoking
throughout pregnancy will be evaluated. The Transtheoretical
Model will be incorporated as a conceptualframework for
describing and predicting the change process involved in
pregnancy smoking cessation. Since MET can be individually
tailored to stage of change for smoking, this alternative
strategy for pregnancy smoking cessation will be compared
with standard care (practitioner advice) in a two-group
experimental design. Data will be collected on factors related
to quitting prenatal tobacco use, as well as on the interactions
that occur with illicit substance use. Participants will
be primarily lower socioeconomic status (SES) and minority
(African-American) pregnant women from urban areas, seeking
drug treatment as well as prenatal care at a comprehensive,
specialized program. The specific aims of the
research are:
1) To characterize smoking patterns and nicotine dependence
in a sample of pregnant, treatment-seeking drug-dependent
women;
2) To establish pretreatment stages of change for quitting
smoking during this pregnancy and their relationship to
other smoking and drug use variables;
3) To determine the clinical effectiveness of a specialized
intervention (MET) for increasing smoking cessation rates
and impacting stage movement; and
4) To identify factors associated with quitting smoking
during pregnancy.
Title: Virtual Practicum for Counseling Tobacco Cessation
in Pregnancy
Principal Investigator: Henderson, Joseph
Institution: Dartmouth Medical School, Hanover, NH
Funding Agency: Not available
Project ID: Not available
Project Funding Period: Not available
Abstract: This project employs an educational model, the
Virtual Practicum (a model that has sound basis in learning
theory and has been shown to be easily used by and acceptable
to health professionals), which can be disseminated via
CD-ROM, via broadband Internet, or via CDROM + dial-up Internet.
This project includes an evaluation to measure the impact
in eight to ten communities in New England and Minnesota
of the educational program on prenatal and primary care
practices' implementation of the USPHS Tobacco Clinical
Practice Guideline recommendations. The Agency for Healthcare
Research and Quality (AHRQ), American College of Obstetrics
and Gynecology (ACOG), Association for Maternal and Child
Health Care Providers (AMCHCP), and the American College
of Preventive Medicine are providing in-kind support to
review program design and help to disseminate this program
to students and practicing clinicians. Initial dissemination
will be followed by expanded efforts to develop marketing
relationships with relevant professional organizations representing
the core audience.
Title: Voucher-Based Incentives to Treat Pregnant Smokers
Principal Investigator: Higgins, Stephen T.
Institution: University of Vermont & State Agricultural
College, Burlington, VT
Funding Agency: National Institute on Drug Abuse
Project ID: DA014028
Project Funding Period: 30 April 2001 – 31 March 2006
Abstract: Maternal cigarette smoking is the most important
preventable cause of poor pregnancy outcomes in the U.S.
and a leading cause of pediatric morbidity and mortality.
Approximately 30% of women in the U.S. are cigarette smokers
when they become pregnant and the prevalence is greater
still among less
educated women. About 80% of these women smoke throughout
their pregnancy. Even among those who quit, 25-30% relapse
during the pregnancy and 70% within 6 months of delivery.
Efficacious interventions have been developed for promoting
smoking cessation during pregnancy, but cessation rates
are low, especially among low-income and highly nicotine-dependent
women (< 15%). Efficacious interventions to prevent relapse
during the postpartum period remain to be developed. We
propose to examine the efficacy of a voucher-based incentive
program for promoting smoking cessation and preventing relapse
during pregnancy and postpartum. This incentive program
is efficacious in promoting and sustaining abstinence in
cocaine and other illicit drug abusers. A recent trial suggested
that vouchers may be efficacious for increasing smoking
cessation among pregnant smokers. The proposed studies are
designed to rigorously evaluate the efficacy of voucher-based
incentives for promoting cessation and extend them to preventing
relapse among pregnant women and new mothers. Two randomized
trials are proposed.
First, we will examine the efficacy of vouchers delivered
contingent on smoking abstinence for increasing cessation
rates during pregnancy and postpartum among 226 women who
are still smoking at their first prenatal visit. Second,
we will examine the efficacy of contingent vouchers for
preventing relapse during pregnancy and postpartum among
96 women who have already quit smoking prior to the first
prenatal visit. Women for both trials will be recruited
from Vermont's largest obstetrical practice, which serves
a large population of uninsured, low-income women. In both
trials, the voucher-based intervention will be added to
brief smoking advice delivered by physicians/midwives and
compared against control conditions wherein brief advice
is combined with vouchers delivered independent of smoking
status. Overall, the proposed studies have the potential
to contribute important new scientific and practical information
on effective treatment for one of our nation's most daunting
drug abuse problems.
Title: Using Cotinine Feedback and Maternity Care Advocates
to Assist Urban, Low-Income
Pregnant Women Reduce Their Nicotine Exposure From Tobacco
Smoke
Principal Investigator: Hock-Long, Linda
Institution: City of Philadelphia Department of Public Health,
Philadelphia, PA
Funding Agency: Not available
Project ID: Not available
Project Funding Period: Not available
Abstract: This study used a quasi-experimental pre-post
comparison design to test the feasibility and effectiveness
of an intervention that coupled routine biochemical screening
at each prenatal visit with systematic advice and expanded
counseling provided by clinicians, indigenous community
health advisors, and maternity care advocates.
Title: Preventing Initiation of Smoking by Children
Principal Investigator: Jackson, Christine
Institution: University of North Carolina Chapel Hill, Chapel
Hill, NC
Funding Agency: National Institute of Child Health and Human
Development
Project ID: HD036514
Project Funding Period: 30 September 1997 – 31 August 2003
Abstract: Children whose parents smoke cigarettes are at
high risk for early initiation of smoking, and those who
initiate smoking during childhood are at high risk for subsequent
addiction to tobacco.
Few programs are available that aim to prevent initiation
of cigarette smoking during childhood, and none is available
that aims to prevent early initiation by engaging parents
who smoke in altering children's smoking-specific socialization.
This project tests an innovative program to change smoking-specific
socialization of children in households where parents smoke
cigarettes. This continuation application requests one additional
year of support for this research. Aim l: Develop an anti-smoking
socialization program for parents who smoke.
Through communication, modeling, rule setting, monitoring,
and other socialization practices, parents influence their
children's perceptions of the prevalence of smoking, the
acceptability of smoking, the accessibility of cigarettes,
and many other aspects of smoking. The premise of this research
is that all parents, including parents who smoke, can engage
in anti-smoking socialization, and that anti-smoking socialization
can lower children's risk of smoking. Barriers to anti-smoking
socialization include the misperception by parents that
initiation of smoking is uncommon during childhood and the
strong belief among parents who smoke that they lack credibility
as sources of anti-smoking socialization. The program developed
for this project addresses these and other barriers to involvement
by parents who smoke in preventing their children from smoking.
Aim 2: Using a 2-group randomized design, test the effects
of antismoking socialization on children's susceptibility
to and initiation of cigarette smoking.
Sample: To date, this study has enrolled 813 mother-child
pairs, where mothers were biological mothers, stepmothers,
or other adult female guardians, from single- or 2-parent
households, who reported smoking at baseline and whose children
were in the 3rd grade at baseline. Design: Eligible participants
who completed the baseline survey were randomly assigned
to the treatment (n = 408) or control (n = 405) condition.
Data on program implementation and impact have been obtained
from mothers using telephone interviews administered 1 month
post-treatment.
Interviews administered to children 12, 24, and 36 months
post-baseline will be used to assess program effects. Hypotheses:
Children exposed to a program of anti-smoking socialization
by mothers who smoke will be less susceptible to and report
less initiation of smoking than unexposed peers. Analyses:
A latent transition model will test the effects of anti-smoking
socialization on children's susceptibility to cigarette
smoking. Survival analysis will test the effects of anti-smoking
socialization on children's initiation of smoking.
Title: Pilot: Nicotine and Exercise Related Energy Expenditure
in Women
Principal Investigator: Jorenby, Douglas E.
Institution: University of Wisconsin Madison, Madison, WI
Funding Agency: National Cancer Institute
Project ID: CA084724-04S10004
Project Funding Period: 30 September 1999 – 31 August 2004
Abstract: On average, smokers weigh less than nonsmokers,
and most smokers gain 2-3 kg of weight in the first six
months of a cessation attempt. Fear of weight gain is a
significant barrier to cessation attempts, particularly
among women who smoke as a weight control strategy. For
all its clinical relevance, little is known about the metabolic
mechanisms of post-cessation weight gain or strategies to
prevent it, esp. in women. This study will utilize a human
indirect calorimetry chamber to assess exercise-related
energy expenditure in 20 pre-menopausal women who are regular
smokers. Each will participate in a pre-cessation assessment
of resting energy expenditure, response to 20 minutes of
standardized light exercise, and recovery time from exercise.
The entire sample will then quit smoking for 72 hours, half
using a 21 mg patch, half without nicotine replacement,
and repeat the
calorimetry assessment. The results should indicate the
degree to which nicotine replacement therapy can increase
exercise-related energy expenditure and/or prolong metabolic
recovery time. Providing women with an active intervention
to address weight gain may increase the number of successful
cessation attempts, and may aid those who relapse due to
fear of weight gain.
Title: Prevention of Tobacco Use in Rural Ethnic American
Youth
Principal Investigator: Kelly, Kathleen
Institution: Colorado State University, Fort Collins, CO
Funding Agency: National Institute on Drug Abuse
Project ID: DA007074
Project Funding Period: Not avilable
Abstract: Project IV: This project will determine whether
localized media campaigns aimed at rural 7th and 8th grade
Mexican American and White non-Hispanic students can influence
their attitudes toward tobacco use and the subsequent use
of tobacco (smoking cigarettes and smokeless tobacco). The
primary target will be young women, where smoking produces
potentially greater damage due to harmful effects to the
fetus, newborn, and infant
among pregnant smoking females. However, media messages
will not be focused solely on females, and effects on males
are expected such as reduction of smokeless tobacco.
An effective and relatively low cost media campaign would
be a valuable asset for rural communities that usually do
not have the financial and technical resources for costly
prevention efforts. However, typical media campaigns may
not be useful for rural communities who may view their problems
as more limited or unique compared to urban environments.
The media campaigns that will be tested, therefore, will
be localized to include local smoking data, identification
with local situations, and images of local landmarks. There
is evidence that prevention efforts may be enhanced by the
use of peers; therefore, the effect of the media campaign
alone (MEDIA) will be compared with the effect of the media
campaign when local peers are added as an integral part
of the media campaign (MEDIA+). In these MEDIA+ communities,
a team of local peers (11th grade women) will be trained
to present and monitor the media campaign. In addition,
they will make radio spots, be names in news releases, and
will be included in local visual references. The addition
of this social influence from older females will be tested
for its ability to reduce cigarette use and smokeless tobacco
among younger females and males, over and above effects
obtained in the MEDIA condition. Both experimental conditions
will be compared to a control condition in which pre- and
post assessments are obtained, with no intervention.
Media components that can be localized to rural ethnic minority
communities have been developed and tested, and the training
program for peer involvement in media campaigns has been
tested by the investigators. The programs are designed so
that, if successful, technology transfer through extension
services or 4H
organizations would be feasible.
Title: Ascertainment of Environmental Tobacco Exposure in
Pregnancy
Principal Investigator: Kharrazi, Martin
Institution: Sequoia Foundation, Berkeley, CA
Funding Agency: California Tobacco-Related Disease Research
Program
Project ID: 8RT-0115
Project Funding Period: 1 July 1999 –30 June 2002
Abstract: Even though it is well-known that the health of
pregnant women and their newborn offspring is damaged be
tobacco smoke, little is known about who in California is
exposed to tobacco smoke during pregnancy, for how long
and how much. One reason for this is that California is
the only state that does not have a smoking question as
part of its birth certificate.
The objectives of this research project are to put together
a source of information to answer these and other questions
about smoking. We will work together with other programs
of the California Department of Health Services, the National
Centers for Disease Control and Prevention (CDC), the San
Diego County Health Department, 20 delivery hospitals, area
medical laboratories, and numerous community clinics and
doctors to do this. We will collect information from pregnant
women in San Diego County during 1999-2001. Blood and urine
taken from pregnant women for non-study reasons and which
is left over after analysis wil1 be collected by the study,
stored and later used to measure how much tobacco smoke
these women were exposed to. We will obtain the blood and
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