Together Everyone Achieves More (TEAM) Trial

NCT ID: NCT05519696

Last Updated: 2024-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-12

Study Completion Date

2026-12-31

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.

Detailed Description

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Conditions

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Physical Activity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
All measurement staff will be blind to treatment condition

Study Groups

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Intervention

This group will receive a 10-week group-based intervention program.

Group Type EXPERIMENTAL

Intervention

Intervention Type BEHAVIORAL

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.

Comparison

The group will receive a 10-week group-based comparison program.

Group Type ACTIVE_COMPARATOR

Comparison

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Allison M. Sweeney

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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College of Nursing, University of South Carolina

Columbia, South Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Allison Sweeney, PhD

Role: CONTACT

803-576-7891

Facility Contacts

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Allison Sweeney, PhD

Role: primary

803-576-7891

References

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Sweeney AM, Wilson DK, Zarrett N, Simmons T, Mansfield M, Decker L. Using formative process evaluation to improve program implementation and accessibility of competitive group-based physical activity in the TEAM-PA trial. Int J Behav Nutr Phys Act. 2024 Aug 13;21(1):88. doi: 10.1186/s12966-024-01635-1.

Reference Type DERIVED
PMID: 39138496 (View on PubMed)

Sweeney AM, Wilson DK, Zarrett N, Martin P, Hardin JW, Fairchild A, Mitchell S, Decker L. An overview of the Together Everyone Achieves More Physical Activity (TEAM-PA) trial to increase physical activity among African American women. Contemp Clin Trials. 2023 Jun;129:107207. doi: 10.1016/j.cct.2023.107207. Epub 2023 Apr 26.

Reference Type DERIVED
PMID: 37116644 (View on PubMed)

Other Identifiers

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R01HL160618

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00113152

Identifier Type: -

Identifier Source: org_study_id

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