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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post-intervention (12 weeks), and 3 months post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post-intervention (12 weeks), and 3 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
Body weight
Secondary outcome measures
Added sugar consumption
Blood pressure (BP)
Body mass index (BMI)
+12 moreOther 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.
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Who is running the clinical trial?
University of South CarolinaLead Sponsor
211 Previous Clinical Trials
120,429 Total Patients Enrolled
30 Trials studying Obesity
8,645 Patients Enrolled for Obesity
National Institute on Minority Health and Health Disparities (NIMHD)NIH
380 Previous Clinical Trials
1,215,624 Total Patients Enrolled
39 Trials studying Obesity
254,200 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a musculoskeletal condition that would make it difficult for you to do the recommended amount of exercise.You have taken any medications, herbs, or supplements for weight loss in the 30 days leading up to the study.You have been treated for cancer, except for non-melanoma skin cancer, within the last year.You have lost more than 5% of your body weight in the last 6 months.You have a lung condition that requires you to use oxygen or take medicine every day to help you breathe.You have any other physical or mental health condition that would make it difficult for you to participate in a weight loss program focused on changing behaviors.
Research Study Groups:
This trial has the following groups:- Group 1: Walking and General Health Education Program
- Group 2: GameDay Ready Program
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still available slots in this clinical investigation?
"Affirmative, the available information on clinicaltrials.gov indicates that this research programme is actively searching for volunteers. This trial commenced on August 1st 2023 and was most recently updated July 24th of the same year. The study needs to enrol 30 people from a single medical facility."
Answered by AI
Is this research endeavor open to those who have exceeded 25 years of age?
"Data from this trial suggest that the ideal patient is aged 25 to 65. For those below 18, there are 182 studies available and for individuals over 65, 611 trials exist."
Answered by AI
How many people are actively enrolled in this medical research study?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical trial is currently recruiting for participants, with the first post dating back to August 1st 2023 and a recent edit on July 24th of the same year. The research team requires 30 volunteers from one location."
Answered by AI
What are the requirements to be eligible for this clinical experiment?
"Qualified participants to this study should have obesity and must be between 25-65 years old. There are 30 spots available in total."
Answered by AI
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