Together Everyone Achieves More (TEAM) Trial (TEAM)

The Together Everyone Achieves More Physical Activity Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Physical Activity
• Intervention / Treatment: Behavioral: Intervention; Behavioral: Comparison

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison Sweeney, PhD; Phone Number: 803-576-7891; Email: sweeneam@mailbox.sc.edu

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • Recruiting
      • College of Nursing, University of South Carolina
      • Contact: Allison Sweeney, PhD; Phone Number: 803-576-7891; Email: sweeneam@mailbox.sc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This group will receive a 10-week group-based intervention program.	Behavioral: Intervention; 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.
Active Comparator: Comparison; The group will receive a 10-week group-based comparison program.	Behavioral: Comparison; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reciprocal Social Support for Physical Activity	The Support for Exercise Scale (Sallis et al 1987) will be adapted [12 items; 1 = Never; 6 = Very Frequently ] to measure providing and receiving of social support among group members. Mean composite scores will be calculated (ranging from 1-6), with higher numbers indicate greater social support.	Baseline, post-intervention (10 weeks), and 6 months post-intervention
Group Cohesion among Group Members	Two subscales (Individual Attraction to the Group - Social; Group Integration - Social) from the Physical Activity Group Environment Questionnaire (Estrabrooks et al 2000) [10 items; 1 = Strongly Disagree, 6= Strongly Agree] will be used to assess group cohesion among group members. Mean composite scores will be calculated (ranging from 1-6), with higher numbers indicate greater group cohesion.	Baseline, post-intervention (10 weeks), and 6 months post-intervention
Group Interactions (Communication, Cooperation, Friendly Competition)	Items developed by Harden et al (2014) [12 items; 1 = Strongly Disagree, 6= Strongly Agree] will be used to assess communication, cooperation, and friendly competition among group members. Mean composite scores will be calculated (ranging from 1-6), with higher numbers indicate more positive group interactions.	Baseline, post-intervention (10 weeks), and 6 months post-intervention
Collective Efficacy for Physical Activity among Group Members	The Unity subscale from the Collective Efficacy Questionnaire for Sports (Short et al. 2005) will be adapted [4 items; 5-point, 1 = Not at all confident, 5 = Extremely confident] to assess collective efficacy for physical activity among group members. A mean composite score will be calculated (ranging from 1-5), with higher numbers indicating greater collective efficacy.	Baseline, post-intervention (10 weeks), and 6 months post-intervention
Relatedness among Group Members	The Need for Relatedness Scale (Richer & Vallerand, 1998) will be used [10 items; 1 = Strongly Disagree, 6= Strongly Agree] to assess relatedness among group members. A mean composite score will be calculated (ranging from 1-6), with higher numbers indicating greater relatedness.	Baseline, post-intervention (10 weeks), and 6 months post-intervention

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: August 22, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: African American women; Community-Based Intervention; Social Environment
• Other Study ID Numbers: Pro00113152; R01HL160618 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The investigators plan to share the Statistical Analysis Plan and Informed Consent Form.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No