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Social Affiliation Intervention for Physical Inactivity (TEAM Trial)
N/A
Recruiting
Research Sponsored by University of South Carolina
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post-intervention (10 weeks), and 6 months post-intervention
Awards & highlights
Summary
This trial is testing whether a group-based social affiliation intervention can help increase physical activity among inactive African American women, compared to a standard group-delivered physical activity program.
Who is the study for?
The TEAM trial is for African American women over 18 who are not very active, doing less than an hour of moderate exercise a week. It's not for those currently pregnant or planning to be soon, with uncontrolled high blood pressure, or with heart or bone problems limiting movement.Check my eligibility
What is being tested?
This study compares a new group-based social program called TEAM-PA aimed at increasing physical activity against a standard exercise program. The goal is to see if the intervention helps inactive women become more active over a period of 10 weeks and maintain it after six months.See study design
What are the potential side effects?
Since this trial involves physical activity programs, potential side effects may include muscle soreness, fatigue, and risk of injury related to exercise. However, these are common reactions when starting any new workout routine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-intervention (10 weeks), and 6 months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (10 weeks), and 6 months post-intervention
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Total Physical Activity
Secondary outcome measures
Blood Pressure
Body Mass Index (BMI)
Light Physical Activity
+3 moreOther outcome measures
Collective Efficacy for Physical Activity among Group Members
Group Cohesion among Group Members
Group Interactions (Communication, Cooperation, Friendly Competition)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 Intervention
This group will receive a 10-week group-based intervention program.
Group II: ComparisonActive Control1 Intervention
The group will receive a 10-week group-based comparison program.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intervention
2011
Completed Phase 4
~73780
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Who is running the clinical trial?
University of South CarolinaLead Sponsor
214 Previous Clinical Trials
120,996 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,512 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a heart or bone condition that limits my ability to move.I am an African American or Black female.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention
- Group 2: Comparison
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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