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

NCT ID: NCT05970042

Last Updated: 2025-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-04
• Study Completion Date: 2026-05-01

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 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

GameDay Ready Program

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

Group Type: EXPERIMENTAL

GameDay Ready

Intervention Type: BEHAVIORAL

GameDay Ready is a 12-week, group-based behavioral weight management program in which participants will meet in-person once per week at a publicly accessible walking track. The GameDay Ready program promotes increasing physical activity, reducing sedentary time, and improving dietary habits through education, behavioral self-monitoring, and goal setting. Each 60-minute intervention session includes a brief educational component followed by a group discussion of weekly progress. Following a short warmup walk, participants engage in group-based competitive physical activities and then a short cooldown walk. Participants then set individual and group-based goals for the upcoming week and discuss strategies for overcoming barriers to achieving goals. The program is sensitive to intersectional influences of gender, race, and rurality on health; and strategies to enhance motivation are threaded throughout the program.

Walking and General Health Education Program

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

Group Type: ACTIVE_COMPARATOR

Walking and General Health Education

Intervention Type: BEHAVIORAL

Participants receiving the comparison program will complete a 12-week walking and general health education program. Group sessions meet once per week at a publicly accessible walking track, and each 60-minute session consists of a brief educational component on a health topic followed by walking and socializing during the remainder of the session.

Interventions

GameDay Ready

GameDay Ready is a 12-week, group-based behavioral weight management program in which participants will meet in-person once per week at a publicly accessible walking track. The GameDay Ready program promotes increasing physical activity, reducing sedentary time, and improving dietary habits through education, behavioral self-monitoring, and goal setting. Each 60-minute intervention session includes a brief educational component followed by a group discussion of weekly progress. Following a short warmup walk, participants engage in group-based competitive physical activities and then a short cooldown walk. Participants then set individual and group-based goals for the upcoming week and discuss strategies for overcoming barriers to achieving goals. The program is sensitive to intersectional influences of gender, race, and rurality on health; and strategies to enhance motivation are threaded throughout the program.

Intervention Type: BEHAVIORAL

Walking and General Health Education

Participants receiving the comparison program will complete a 12-week walking and general health education program. Group sessions meet once per week at a publicly accessible walking track, and each 60-minute session consists of a brief educational component on a health topic followed by walking and socializing during the remainder of the session.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Demetrius Abshire

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of South Carolina

Columbia, South Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Demetrius A Abshire, PhD

Role: CONTACT

abshired@mailbox.sc.edu

803-576-6262

Facility Contacts

Demetrius A Abshire, PhD

Role: primary

abshired@mailbox.sc.edu

803-576-6262

Other Identifiers

5K23MD013899

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00127414

Identifier Type: -

Identifier Source: org_study_id