NCT05530980

"GameDay Ready": Evaluating a Behavioral Weight Management Program for Black Men Living in the Rural South

Completed NA Results posted Last updated 2 February 2024

What this trial tests

NA trial testing GameDay Ready Program in Obesity in 7 participants. Completed in 1 June 2023.

Timeline

19 August 2022

Primary endpoint
1 April 2023

1 June 2023

Quick facts

Lead sponsor	University of South Carolina
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	7
Start date	19 August 2022
Primary completion	1 April 2023
Estimated completion	1 June 2023
Sites	1 location across United States

Drugs / interventions tested

• GameDay Ready Program

Conditions studied

• Obesity — all drugs for Obesity →
• Physical Inactivity — all drugs for Physical Inactivity →
• Diet, Healthy — all drugs for Diet, Healthy →

Sponsor

University of South Carolina

Who can join

Adults 25 to 50, male only, with Obesity or Physical Inactivity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Study Interest Primary · Up to week 1

Number of people expressing interest in the study

Group	Value	95% CI
GameDay Ready Program	91

Eligibility Primary · Up to week 1

Number of men who express interest in the study and are eligible.

Group	Value	95% CI
GameDay Ready Program	14

Time to Enroll Primary · Up to week 1

Length of time needed to enroll the desired sample size (length of time reflects when recruitment was initiated until study launch)

Group	Value	95% CI
GameDay Ready Program	5

Attendance Primary · Baseline to 3 months

Number and proportion of enrolled men who attend each intervention session and total number of sessions. Percentage of sessions attended calculated as the total number of sessions attended divided by total number of sessions offered.

Percentage of sessions attended based on 7 enrolled participants.

Group	Value	95% CI
GameDay Ready Intervention	49

Percentage of sessions attended excluding one participant who attended 0 sessions.

Group	Value	95% CI
GameDay Ready Intervention	57

Percentage of sessions attended excluding participants who attended 0 or just 1 session.

Group	Value	95% CI
GameDay Ready Intervention	67

Attrition Primary · Baseline to 3 and 6 months

Number and percentage of enrolled men who withdraw from the study

Number of enrolled participants remaining in study at 3 months.

Group	Value	95% CI
GameDay Ready Intervention	5

Number of enrolled participants remaining in study at 6 months.

Group	Value	95% CI
GameDay Ready Intervention	4

Sponsor's own description

The primary objective of this study is to test the feasibility and acceptability of a 12-week behavioral weight management intervention adapted for Black men living in the rural South. The intervention is guided by Self-Determination Theory of Motivation, Social Cognitive Theory, and Ecological Systems Theory. Key aspects of the intervention include a football-themed curriculum, facilitator and peer concordance to the extent possible (ie., similarly aged Black men), an emphasis on male-specific health concerns, group-based competition at multiple levels of the intervention (e.g., during in-person physical activity sessions and for achieving behavioral goals), a limited educational component, and physical activity being a substantial component of meeting sessions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.