Together Everyone Achieves More (TEAM) Trial

Not Applicable

Recruiting

• Conditions: Physical Activity

• Registration Number: NCT05519696
• Lead Sponsor: University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-29
• Study Start: 2022-09-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-24
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 360

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Total Physical Activity	Baseline, post-intervention (10 weeks), and 6 months post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Percentage meeting national guidelines for weekly moderate to vigorous physical activity	Baseline, post-intervention (10 weeks), and 6 months post-intervention	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.
Light Physical Activity	Baseline, post-intervention (10 weeks), and 6 months post-intervention	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.
Sedentary Behavior	Baseline, post-intervention (10 weeks), and 6 months post-intervention	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.
Body Mass Index (BMI)	Baseline, post-intervention (10 weeks), and 6 months post-intervention	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.
Blood Pressure	Baseline, post-intervention (10 weeks), and 6 months post-intervention	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.
Two-Minute Walk Test (Walking Speed)	Baseline, post-intervention (10 weeks), and 6 months post-intervention	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.

Trial Locations

Locations (1)

College of Nursing, University of South Carolina; 🇺🇸 Columbia, South Carolina, United States