Obesity Clinical Trial
Official title:
Evaluation of the National Black Women's Health Project Walking for Wellness Program
The overall purpose of this project is to conduct an innovative, culturally-tailored
demonstration project designed to facilitate the adoption and maintenance of regular,
moderate physical activity (i.e., brisk walking) in a sample of sedentary African American
women. In addition, we will test the impact of varying types of counseling and social
support on the adoption and maintenance of regular physical activity and help women improve
their weight control. The core behavioral change program will be based on a comprehensive
wellness oriented website offered by the National Black Women's Health Project (NBWHP).
Comparisons will be made between the effects of the web-based program with only minimal face
to face contacts, primarily for enrollment, data collection, and participant retention, the
web-based program with the addition of telephone counseling and support, and the web-based
program with face to face group counseling and support.
Hypotheses. Hypothesis 1. Participation in the intervention will result in increased
physical activity levels, regardless of the level of social support.
Hypothesis 2. The intervention arm involving the lowest level of social support will be
marginally effective for increasing physical activity levels, and additional social support
will result in significantly improved physical activity levels when compared with the lowest
level of social support.
The specific intervention questions are:
1. How well do the interventions address the program objectives ((quality of
implementation), to be determined through protocol review for operationalization of
theoretical constructs)?
2. Was the program implemented as planned ((fidelity to protocol and dose of
intervention), to be determined from implementation process variables, including
characteristics of women recruited, fidelity to protocols for contact with
participants, and quality of counseling given, where applicable)?
3. Did the program (separately for each format tested) have a significant effect on
potential mediators of behavior change (influence on presumed intermediate outcomes)?
For the purpose of this proposal, a mediator is defined as any barrier to or
facilitator of physical activity participation (e.g., time, self efficacy, social
support, access, perceived norms) as implied in the 12 behavioral objectives that have
been specified.
4. What is the optimum type of counseling and support to enhance the on-line activities in
order to produce significant behavior change (importance of various program
components)?
5. Did the program (separately for each format tested) have a significant effect on the
primary study outcomes (influence on primary behavioral outcome, e.g., physical
activity by self-report of activity levels or pedometer counts)?
6. Do changes in mediators explain changes in the primary outcomes (multivariate models to
understand if presumed process of behavioral change was observed in practice)?
7. Does the internet only program appear to result in increased physical activity
participation when compared to extant data on trends among Black women in the U.S.
population (what is accomplished with very minimal intervention and how does it compare
with a more extensive program)?
n/a
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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