Status:
RECRUITING
Investigating the Effects of the "GameDay Ready" Behavioral Weight Management Program for Black Men Living in the Rural South
Lead Sponsor:
University of South Carolina
Collaborating Sponsors:
National Institute on Minority Health and Health Disparities (NIMHD)
Conditions:
Obesity
Eligibility:
MALE
25-65 years
Phase:
NA
Brief Summary
This pilot study investigates the effects of a newly developed 12-week weight management program called "GameDay Ready" (compared to a walking and general health education program) for decreasing body...
Eligibility Criteria
Inclusion
- Self-identified African American or Black American male
- 25-65 years of age
- BMI 27kg/m2 to ≤50kg/m2 (those with a BMI \>45 will need documented approval by a healthcare provider to participate in the study)
- Live in a rural area of South Carolina and have lived in a rural area for at least 1 year
- Able to speak and understand English
- Willing to be randomized to the intervention or comparison program
Exclusion
- Positive response to any question on the Physical Activity Readiness Questionnaire (PAR-Q) (Participant may be included if approval is provided and documented by a healthcare provider)
- Currently participating in another weight loss trial or program or have participated in a trial or program within 6 months prior to starting the intervention
- Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg), diabetes, or asthma (Participant may be included if approval is provided and documented by a healthcare provider)
- Pulmonary disease requiring supplemental oxygen or daily use of short-acting bronchodilators
- Any musculoskeletal condition that would preclude meeting recommended levels of moderate-to- vigorous physical activity
- Within 30 days prior to participating in the study, have taken prescription or nonprescription medications, herbals, or supplements for weight loss
- On special diet for a serious health condition (does not include general dietary advice from a healthcare provider for common risk factors such as hypertension, diabetes, or hyperlipidemia).
- Major surgery in the past 6 months
- Have undergone weight loss surgery or considering weight loss surgery within the next 6 months
- Have been treated for cancer in the past 12 months (other than non-melanoma skin cancer)
- Weight loss ≥5% during the past 6 months
- Plans to move to another county in the next 6 months
- Any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss
Key Trial Info
Start Date :
August 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05970042
Start Date
August 4 2023
End Date
May 1 2026
Last Update
April 30 2025
Active Locations (1)
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1
University of South Carolina
Columbia, South Carolina, United States, 29208