A Program to Increase Physical Activity Among Blacks
Condition: Physical Activity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Faith-based; Non-faith-based
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The faith-based intervention will include 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. All items will be delivered with biblical references to further guide the participants.; The non-faith based intervention will include 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. All items will be delivered without biblical references as in the faith-based intervention.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: Physical Activity; Faith based; Non faith based; African American; Female; Pedometers