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

NCT05970042 | Recruiting

• 2 other identifiers: Pro001274145K23MD013899
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Body weight

  Participants' body weight will be measured in pounds using a portable, professional-grade scale. Changes in body weight will be compared between the intervention and comparison programs.

  Baseline, post-intervention (12 weeks), and 3 months post-intervention

Secondary Outcomes (15)

• Body mass index (BMI)

  Baseline, post-intervention (12 weeks), and 3 months post-intervention

• Waist circumference (WC)

  Baseline, post-intervention (12 weeks), and 3 months post-intervention

• Blood pressure (BP)

  Baseline, post-intervention (12 weeks), and 3 months post-intervention

• Moderate-to-vigorous physical activity (MVPA)

  Baseline, post-intervention (12 weeks), and 3 months post-intervention

• Fruit and vegetable consumption

  Baseline, post-intervention (12 weeks), and 3 months post-intervention

Other Outcomes (2)

• Neighborhood surroundings

  Baseline, post-intervention (12 weeks), and 3 months post-intervention

• Neighborhood safety

  Baseline, post-intervention (12 weeks), and 3 months post-intervention

Study Arms (2)

GameDay Ready Program

EXPERIMENTAL

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

Behavioral: GameDay Ready

Walking and General Health Education Program

ACTIVE COMPARATOR

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

Behavioral: Walking and General Health Education

Interventions

GameDay Ready 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.

GameDay Ready Program

Walking and General Health Education 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.

Walking and General Health Education Program

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identified African American or Black American male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Walking

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Central Study Contacts

Demetrius A Abshire, PhD

CONTACT

803-576-6262; abshired@mailbox.sc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: August 4, 2023
• Primary Completion: January 31, 2026
• Study Completion: May 1, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)