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Behavioural Intervention

"GameDay Ready" Program for Obesity

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 (12 weeks), and 3 months post-intervention
Awards & highlights

Study Summary

This trial looks at a 12-week weight loss program ("GameDay Ready") for Black men in the rural South, compared to a walking and health education program. Outcomes are expected to show greater weight loss with the new program.

Who is the study for?
Black men aged 25-65 living in rural South Carolina, with a BMI of 27 to ≤50 (approval needed if >45), can join this weight management study. They must speak English and be okay with random program assignment. Exclusions include recent major surgery, other weight loss programs within the last 6 months, uncontrolled hypertension or diabetes, severe asthma, certain musculoskeletal conditions, and some medication use.Check my eligibility
What is being tested?
The 'GameDay Ready' program is being tested against a walking and general health education program for its effectiveness in reducing body weight over a period of 12 weeks among Black men residing in the rural South who are part of the study.See study design
What are the potential side effects?
Since 'GameDay Ready' is a behavioral intervention focusing on weight management through lifestyle changes rather than medication or medical procedures, side effects may include muscle soreness from increased physical activity but are generally expected to be minimal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (12 weeks), and 3 months post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, post-intervention (12 weeks), and 3 months post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Body weight
Secondary outcome measures
Added sugar consumption
Blood pressure (BP)
Body mass index (BMI)
+12 more
Other outcome measures
Neighborhood safety
Neighborhood surroundings

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GameDay Ready ProgramExperimental Treatment1 Intervention
GameDay Ready is a 12-week, group-based behavioral weight management program.
Group II: Walking and General Health Education ProgramActive Control1 Intervention
The walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men.

Find a Location

Who is running the clinical trial?

University of South CarolinaLead Sponsor
213 Previous Clinical Trials
121,226 Total Patients Enrolled
30 Trials studying Obesity
8,876 Patients Enrolled for Obesity
National Institute on Minority Health and Health Disparities (NIMHD)NIH
393 Previous Clinical Trials
1,221,010 Total Patients Enrolled
40 Trials studying Obesity
254,724 Patients Enrolled for Obesity

Media Library

GameDay Ready (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05970042 — N/A
Obesity Research Study Groups: Walking and General Health Education Program, GameDay Ready Program
Obesity Clinical Trial 2023: GameDay Ready Highlights & Side Effects. Trial Name: NCT05970042 — N/A
GameDay Ready (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05970042 — N/A
~11 spots leftby Jan 2025
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