Physical Activity Clinical Trial
Official title:
A Faith-Based Intervention to Increase Physical Activity Among Blacks
The purpose of this research study is to evaluate three different approaches for increasing physical activity in African American women who are not currently doing enough physical activity. One approach will teach people about physical activity, in groups, using general principles (general physical activity program). The second approach will teach people about physical activity, in groups, using principles from the bible (faith-based physical activity program). The third approach will teach people about physical activity by giving them written materials created at the National Institutes of Health (control group). Control groups are used in research studies to see if the program being studied really does have an effect on physical activity. At the end of the study, people in the control group will also participate in either the general physical activity program or the faith-based physical activity program.
The intervention will be conducted in 24 churches. Participating churches will be recruited
from the list of churches that participated in the Health Ministry Institute, a program
including ~40 minority-serving churches in Forsyth County conducted by Dr. Whitt-Glover 2
years ago. We will enroll churches from the list of participating HMI churches over a
two-year period until 24 churches have been recruited for randomization. If we exhaust the
list of HMI before we have 24 churches enrolled in the study, we will place advertisements in
local newspapers and send out directed mailings to the ~210 minority-serving churches in
Forsyth County, NC explaining the study and inviting them to send a representative to a study
information session to learn more.
Eligible participants will include 480 African American women > 18 years of age who report
that they are not currently meeting the guidelines for regular moderate or vigorous physical
activity. Participants should have no physical limitations or disabilities that would limit
physical activity participation. In addition, participants should have no contraindications
for increasing daily physical activity, such as recent myocardial infarction or congestive
heart failure, and should be willing to participate in a two-year study.
Participants in the active intervention will participate in 24 group sessions. Sessions 1 -
16 will occur weekly, sessions 17 - 20 will occur bi-weekly, and sessions 21 - 24 will occur
monthly. Sessions will be scheduled to last for 90 minutes each. This will include a
30-minute physical activity session (led by a trained exercise leader) and 60 minutes of
group discussion (led by a Community Health Worker trained in group facilitation, familiarity
with theology and health ministry education, and experience implementing group-based
activities in faith settings). Group discussion content will be standardized to ensure
consistent delivery.
Thirty-Minute Physical Activity Session. At the beginning of each weekly meeting and
immediately prior to the group discussion, participants will engage in a standard 30-minute
physical activity session led by a trained exercise leader. The 30-minute physical activity
session will include warm-up, an activity period, and cool down. Inclusion of an exercise
period during the weekly sessions proved to be a motivator for on-time arrival to weekly
sessions during the pilot study, as well as an opportunity for participants to learn methods
for proper warm-up and cool-down prior to and following physical activity, as well as time to
rehearse using physical activity incentives (e.g., exercise tapes, hand weights), and to
understand the body's physiological reactions to moderate-intensity physical activity (i.e.,
many participants in the pilot study were not exactly sure what moderate-intensity physical
activity felt like (e.g., how hard should they be breathing, what should heart rate be?) and
may not have engaged in the appropriate intensity-level for physical activity outside of
class without opportunities to rehearse activity in class).
Group-Based Intervention Sessions. The group discussion sessions will be led by a Community
Health Worker and the format will be similar for each group and will include five segments:
1. Prayer/scripture and check-in (5 minutes). To ensure the cultural appropriateness of the
intervention each session in both active arms of the intervention will begin with prayer
and reading of an assigned scripture, and will end with prayer, as most church-based
activities begin and end this way. By deliberately writing this into both the
faith-based and non-faith-based intervention, we can control the amount of spirituality
that will be naturally incorporated into the non-faith-based curriculum, which has been
a limitation in previous studies comparing faith- and non-faith-based curricula.
2. Review of participant progress in implementing the strategies recommended for changing
their physical activity in the previous session (10 minutes). We will use the five-step
approach from the continuous care problem-solving model for this segment. The underlying
assumption is that problems are a normal part of behavior change and that solutions must
be tailored to each individual. The 5 steps include: 1) problem orientation, 2) problem
definition and formulation, 3) generation of alternatives, 4) systematic decision
making, and 5) implementation and verification. The group leaders will encourage
participants to openly describe the progress they have achieved, and to identify any
problems they might have encountered. Good progress will be highlighted with strong
positive feedback. Difficulties will be dealt with through group support and advice.
3. Skill training (30 minutes) will be related to the new content to be presented during
the session and cognitive-behavioral self-management skills (e.g., goal setting,
self-monitoring). Content will be delivered from a faith-based perspective incorporating
biblical principles or from a non-faith-based perspective that does not include biblical
principles.
4. Goal setting (10 minutes). Participant will be asked to identify specific behavioral
goals for the next period and will receive feedback and encouragement from the group.
Participants will be compensated for completing all three rounds of data collection.
Participants who miss a scheduled data collection visit will be contacted for up to two weeks
after the missed visit to attempt to collect the data. At minimum, participants will be asked
to report pedometer steps to ensure collection of data related to the primary variables of
interest.
Pedometer-Assessed Daily Walking. Daily walking will be measured using a pedometer and a
physical activity log in which to record the daily number of steps taken by each study
participant. Studies have demonstrated the feasibility of the pedometer both as an objective
measure of physical activity and as a potential motivator to increase physical activity
levels. All participants will receive the New Lifestyle Pedometer 2000 (NL-2000) at the
beginning of the study, and will be asked to keep a record of daily walking on a study log
sheet throughout the active intervention period. The NL-2000 also stores walking data for up
to 7 days and automatically resets at the beginning of each day, reducing participant burden
to remember to reset and record pedometer data each day, and also increasing the likelihood
that we will be able to collect complete data on walking for all participants. Participant
logs will be reviewed, and feedback will be provided, at the beginning of each group session
during the review of participant progress. Participants will measure walking using the
NL-2000 daily throughout the active intervention phase.
Accelerometer-Assessed Daily Moderate-to-Vigorous Physical Activity. Participation in daily
bouts of moderate-to-vigorous physical activity will be assessed using the Actical
Accelerometer (MiniMitter Company, Inc, Bend, OR). Participants will wear wrist-mounted
accelerometers for seven consecutive days (one week) at the baseline, 10 month, and 22 month
data collection visits. Several continuous variables may be calculated from accelerometer
data, including total daily energy expenditure through physical activity, total daily
participation in inactivity and light-, moderate-, and vigorous-intensity activity, the
average length of each bout of activity at a given intensity level, adherence to the
moderate- and vigorous-intensity physical activity recommendations, and adherence to the
recommended bout length.
Self-efficacy will be assessed as self-regulatory efficacy and performance efficacy. A
barriers self-efficacy scale will be employed as a means of evaluating a key self-regulation
process component of the social cognitive framework for the intervention, that is, problem
solving necessary to address barriers in their pursuit of changing lifestyle behaviors. The
physical activity measure is a 14-item scale that is predictive of 6-month and 1-year
adherence to physical activity.
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