Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02103582 |
| Other study ID # |
2012-1516 Georgetown Lombardi |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
March 27, 2014 |
| Last updated |
November 27, 2017 |
| Start date |
April 2013 |
| Est. completion date |
November 2017 |
Study information
| Verified date |
November 2017 |
| Source |
Georgetown University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The Quit & Fit intervention will be designed as a 12-week study to promote smoking cessation,
increase physical activity levels, and reduce weight gain through regular exercise and
healthy nutrition for African American Women smokers.
Patients will be assigned to the fitness intervention group or control groups by a computer.
Description:
1. * Purpose of project (one or two sentences): The feasibility phase of the proposed study
is comprised of a two-arm randomized pilot trial to evaluate the feasibility,
satisfaction, and preliminary efficacy of 'Quit & Fit'. Women (N=40) will receive 12
weekly smoking cessation telephone counseling sessions. Participants will be randomized
to either a fitness intervention (Quit & Fit) or a contact time control (Quit for Life).
2. * Study design (for example, hypothesis, research questions, standard and experimental
procedures/drugs/devices or equipment, etc.):
The Quit & Fit intervention will be designed as a 12-week, tailored multiple health
outcome intervention to promote smoking cessation, achieve energy balance, and reduce
post-cessation weight gain through regular PA and healthy nutrition for AAW smokers.
Culturally tailored comprehensive interventions that address smoking-cessation and
obesity/weight-control among AAW are needed. The conceptual basis of the proposal is
Albert Bandura's social cognitive Theory (SCT), which posits that people learn through
observation and modeling of behaviors, attitudes, and emotional reactions. When applied
to smoking cessation and health behavior change, social learning can be viewed as a
transition through stages of increased knowledge, self-efficacy, and social support,
culminating in readiness to change behaviors. The SCT model allows for targeting of
factors relevant to a given individual and tailoring messages to each each participant's
cultural values. Participants will be randomized into one of the study groups: the
'control arm' or the 'exercise arm'. Both groups will receive 12 weeks of smoking
cessation counseling, telephone counseling and and will receive 10 weeks of nicotine
replacement therapy (NRT) in the form of nicotine lozenges.
Participants who are randomized to the 'control arm' will be asked to maintain their
current daily activities for 12 weeks. They will also be required to visit the study
site 3 times per week for 12 weeks to view videos on different wellness topics. Control
participants will have anthropometric measurements of weight, height, hip size and waist
size taken at the beginning of the study, 6 weeks, and at 12 weeks. Control participants
will also have a fitness test on a treadmill, full body scan, blood pressure, heart rate
and questionnaires given at the beginning of the study, 6 weeks and at 12 weeks.
Participants who are randomized to the 'intervention arm' will be asked to come to the
study site to exercise 3 days per week for 12 weeks. The exercise duration will increase
over time from 75 minutes per week to 150 minutes per week. Intervention participants
will have anthropometric measurements of weight, height, hip size and waist size taken
at the beginning of the study, 6 weeks, and at 12 weeks. Intervention participants will
also have a fitness test on a treadmill, full body scan, blood pressure, heart rate and
questionnaires given at the beginning of the study, 6 weeks and at 12 weeks.
The proposed design of the intervention is to provide high does of education, support,
NR, and structured exercise to optimize success experiences that can build self-doses in
the first sessions. As the intervention progresses, support through mobile phones will
be used to assist with problem solving and social support as participants transition to
self-management. Content will be based on the extant literature on tobacco cessation,
nutrition, and exercise interventions, with emphasis given to published descriptions of
interventions tailored for AAW. Examples of resources from which content may be drawn
include Commit to Quit, Smoke Free Woman (NCI), Pathways to Freedom (2003 version), and
the Diabetes Prevention Program. Key content messages will be developed for each
counseling session. all print materials will be specifically targeted with visual images
and content that has been found to engage AAW. Focus groups will be conducted with women
representing the targeting population in order to develop the messages and visual
content. These qualitative data will be critical in the development of intervention
materials that engage and connect with the women. Focus groups will be conducted during
the first 3 months of the award, with the primary goal of furthering tailoring
intervention materials and protocols to the lives of African-American women residing in
urban District of Columbia (DC) neighborhoods. A total of 4 groups will be run with 8
women in each. The demographic makeup of the groups will resemble that of our target
population on such factors as educational attainment and socio-economic status (SES).
Participants will be recruited through outreach methods (flyers, community talks) used
successfully by Dr. Adams-Campbell's community lab. The multiple principal investigators
(MPIs) will refine the focus group facilitator's guide and review focus group
transcripts and notes to maintain protocol integrity. Open-ended questions will probe
views on target health behaviors as well as preferred information delivery modalities
and ways to remain in contact and provide optimal support. All focus groups will be
audio-taped, with a research assistant taking notes at each of the sessions. Audiotapes
will then be transcribed and translated in order to analyze their content.
3. * Rationale and justification for study (i.e. historical background, investigator's
personal experience, pertinent medical literature, etc.): Smoking is the leading cause
of preventable morbidity and mortality in the US. African Americans experience clear
disparities in disease and death from smoking. African American women (AAW) are an
important subgroup to study because they are distinct from non-AAW and their male
African American counterparts on biopsychosocial factors that are relevant to smoking
behavior. In particular, AAW have lower smoking rates compared to Caucasian women (CAW)
yet similar lung cancer rates. Additional evidence indicates that AAW are more likely to
develop cancer of the larynx, esophageal cancer, cerebrovascular disease, and
cardiovascular disease than CAW. African American smokers are less likely to be screened
by providers for tobacco use, receive advice to quit, or use cessation aids during a
quit attempt, even after controlling for health service use and socioeconomic factors.
Smoking cessation is the single most important preventative health behavior AAW can
engage in to significantly reduce their chances of morbidity and premature mortality
related to smoking related illnesses. Due to their disparate smoking-related health
outcomes, targeted and tailored smoking cessation interventions are extremely critical
for AAW.
Along with the disease burden of tobacco use, sedentary lifestyles and obesity pose
heightened concerns for chronic diseases such as diabetes and vascular disease among AAW. In
2008, AAW had higher incidence of and mortality attributed to coronary heart disease, stroke,
heart failure, and high blood pressure, as compared to non-Hispanic Whites or Hispanics.
Energy balance is defined as the balance between energy taken in, generally by food and
drink, and energy expanded. Lifestyle behaviors strongly linked to obesity are taken in,
generally by low levels of physical activity (sedentary lifestyle) or high consumption rates
of high-fat or energy-dense diets, or both. African Americans have been found to have
different dietary traditions than Caucasians and to consume a higher percentage of calories
from fat even after controlling for individual characteristics and neighborhood SES. Despite
robust evidence of the cancer-protective and health promoting influence of physical activity
(PA), more than 50% of Americans do not engage in adequate levers of PA. A recent study
identified both physical inactivity and smoking as two health behaviors for which relative
inequalities are increasing among those with less formal education compared with those with
more. SES-related obesity disparities are also increasing in women and among African
Americans. There is indeed a public health call for evidence-based research on both
regionally and culturally targeted energy balance strategies that can effectively reach and
engage African Americans.
Nearly all evidence-based smoking cessation programs address the importance of post-cessation
weight gain through dietary choices and PA. However, these issues are not typically
emphasized as centrally important to the likelihood of success of the cessation attempt.
Likewise, weight control programs and initiatives that promote PA give only minimal attention
to tobacco cessation. Questions remain about the most effective ways to implement
interventions that simultaneously address multiple health behaviors. However, evidence
continues to emerge to suggest that such interventions are not only feasible, but have
advantages over approaches that focus on a single health promotion behavior. A targeted
multiple health outcome intervention has promise to change health behaviors that will lead to
improved health and ultimately reduce cancer death disparities among AAW. Culturally tailored
comprehensive interventions that address smoking-cessation and obesity/weight-control among
AAW are needed. This pilot project seeks to develop a combined health promotion intervention
tailored for urban AAW smokers. "Quit & Fit" will be designed as a 12-week program to promote
smoking cessation and achieve energy balance through regular PA and healthy nutrition. The
first several weeks of the intervention will provide maximum structured in-person support
which will be tapered over time and followed by tailored mobile phone sessions to provide
ongoing support, counseling, and assist with the transition from initial structured
counseling to self-management. The program will employ evidence-based strategies that meet
the needs and preferences of AAW in an urban environment.
Many studies have focused on the various health problems we aim to target, but in the other
studies, these interventions have focused on only one aspect of the problem, e.g., smoking
cessation alone or PA alone. The success of the proposed multiple health outcome intervention
would also contribute novel findings to addressing the leading health behaviors (tobacco use,
PA, diet) associated with morbidity and mortality among minority and low-income populations
in this country. The opportunity to engage women at one time across multiple behaviors in a
targeted and cost-effective way has significant implications. Moreover, the use of technology
(cell phones) to provide support for adherence to the programs is at the cutting edge of
health care delivery. Cell phones are a cost-effective way to maintain contact with, and
provide support to difficult-to-engage patients. As reviewed, tailored messages delivered by
phone have been found effective to change energy balance among urban African Americans.
Moreover, the focus of the study on building self-efficacy through structured exercise and
counseling in the initial sessions and then providing support transitioning behaviors from
the structured sessions to the home environments is a unique design that can optimize
retention and sustained behavior change. This program could have a profound impact on
reducing tobacco-related health disparities with important implications for developing
cost-efficient ways of engaging this and many other patient populations.
