Investigating the Effects of the "GameDay Ready" Behavioral Weight Management Program for Black Men Living in the Rural South

University of South Carolina

Status: Enrolling

Conditions: Obesity

Treatments: Behavioral: GameDay Ready; Behavioral: Walking and General Health Education

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05970042

Pro00127414

5K23MD013899 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 weight among Black men who live in the rural South. The researchers expect to see evidence of greater weight loss among participants randomized to receive the "GameDay Ready" program.

Enrollment: 30 estimated patients

Sex: Male

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

GameDay Ready Program

Experimental group

Description:

GameDay Ready is a 12-week, group-based behavioral weight management program.

Treatment:

Behavioral: GameDay Ready

Walking and General Health Education Program

Active Comparator group

Description:

The walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men.

Treatment:

Behavioral: Walking and General Health Education