Together Everyone Achieves More (TEAM) Trial

Study Overview
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Brief Summary
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The Together Everyone Achieve More (TEAM) Physical Activity trial evaluates the efficacy of a group-based social affiliation intervention (vs. a standard group-delivered physical activity comparison program) for increasing physical activity among inactive African American women. Using a group cohort randomized design implemented at community centers across five years, the primary aim of this study is to evaluate the efficacy of the 10-week TEAM-PA group-based intervention (vs. comparison program) on increasing daily total physical activity from baseline to post-intervention and maintenance at a 6-month follow-up.

Official Title
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The Together Everyone Achieves More Physical Activity Trial

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Intervention
* Behavioral: Comparison


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years of age self-identifying as an African American or Black female engaging in < 60 minutes of moderate to vigorous physical activity per week for the last three months Exclusion Criteria: having a cardiovascular or orthopedic condition that would limit physical activity (including walking with a cane/walker) currently pregnant or planning to become pregnant in the next 2 months uncontrolled blood pressure (systolic >180 mmHg/diastolic > 110 mmHg)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>This group will receive a 10-week group-based intervention program. | Behavioral: Intervention<br>* Participants receiving the intervention will complete a 10-week group program. Group sessions meet once per week for 2 hours and include three components - discussion-based health promotion initiative, team-based physical activity games/activities, and team-based goal-setting and behavioral skills training. The health promotion initiative uses cultural targeting and includes a focus on cultural topics related to collectivism. Participants receive FitBits to track their physical activity and through the FitBit mobile app are connected to their group members to encourage communication and social support.<br>|
| Active Comparator: Comparison<br>The group will receive a 10-week group-based comparison program. | Behavioral: Comparison<br>* Participants receiving the comparison program will complete a 10-week group program. Group sessions meet once per week for 2 hours and include three components - discussion-based health promotion initiative, group walking program, and individual-based goal-setting and behavioral skills training. The health promotion initiative uses cultural targeting only (and no focus on collectivism). Participants receive FitBits to track their physical activity, but are not connected to their group members on the mobile app.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Physical Activity | Average minutes of total physical activity (PA) per day; Objective assessments of total PA will be obtained with ActiGraph accelerometers. Participants will wear the monitor on the non-dominant wrist for 7 consecutive days. The investigators will evaluate whether there is a change in minutes of total PA per day from baseline to 10 weeks and maintenance at 6 months post-intervention, and whether there are group differences between the intervention and comparison programs. | Baseline, post-intervention (10 weeks), and 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage meeting national guidelines for weekly moderate to vigorous physical activity | Percentage of participants with at least 150 minutes of moderate physical activity and/or 75 minutes of vigorous physical activity per week; Objective assessments of minutes of moderate to vigorous physical activity will be obtained with ActiGraph accelerometers. The investigators will evaluate whether there is a change in the percentage of participants meeting national guidelines from baseline to 10 weeks and maintenance at 6 months post-intervention, and whether there are group differences between the intervention and comparison programs. | Baseline, post-intervention (10 weeks), and 6 months post-intervention | 
| Light Physical Activity | Average minutes of light physical activity (PA) per day; Objective assessments of light PA will be obtained with ActiGraph accelerometers. The investigators will evaluate whether there is a change in daily minutes of light PA from baseline to 10 weeks and maintenance at 6 months post-intervention, and whether there are group differences between the intervention and comparison programs. | Baseline, post-intervention (10 weeks), and 6 months post-intervention | 
| Sedentary Behavior | Average minutes of sedentary behavior per day; Objective assessments of sedentary behavior will be obtained with ActiGraph accelerometers. The investigators will evaluate whether there is a change in sedentary behavior from baseline to 10 weeks and maintenance at 6 months post-intervention, and whether there are group differences between the intervention and comparison programs. | Baseline, post-intervention (10 weeks), and 6 months post-intervention | 
| Body Mass Index (BMI) | Height (cm) and weight (kg) will be measured using a stadiometer and medical-grade scale. Scores will be used to calculate BMI (kg/m^2). The investigators will evaluate whether there is a change in BMI from baseline to 10 weeks and maintenance at 6 months post-intervention, and whether there are group differences between the intervention and comparison programs. | Baseline, post-intervention (10 weeks), and 6 months post-intervention | 
| Blood Pressure | Systolic and diastolic blood pressure will be measured using an automatic blood pressure machine. The investigators will evaluate whether there is a change in blood pressure from baseline to 10 weeks and maintenance at 6 months post-intervention, and whether there are group differences between the intervention and comparison programs. | Baseline, post-intervention (10 weeks), and 6 months post-intervention | 
| Two-Minute Walk Test (Walking Speed) | Starting from a standing position, participants are asked to walk as far as they can in a safe manner for two minutes over a flat out and back 50 feet course. The distance traveled to the nearest foot is recorded. | Baseline, post-intervention (10 weeks), and 6 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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African American women, Community-Based Intervention, Social Environment