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

Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American Men Living in the Rural South

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diet, Healthy; Physical Inactivity
• Intervention / Treatment: Behavioral: GameDay Ready Program

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Self-identified African American or Black American male
• BMI 27kg/m^2 to 50kg/m^2 (healthcare provider approval required for those with a BMI >45)
• Able to speak and understand English

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 intervention, 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 surgery
• Have been treated for cancer in the past 12 months (other than non-melanoma skin cancer)
• Weight loss ≥5% during the past 6 months
• Any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss
• Intending to move within 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: GameDay Ready Program; The GameDay Ready Program is a 12-week, football-themed, behavioral weight management intervention that promotes gradual increases in physical activity, reductions in sedentary time, and improvements in dietary habits through education, self-monitoring of physical activity and diet, personalized goal setting, group-based competition, social support, identifying and overcoming barriers, and including physical activity as a substantial component of meeting sessions. The program is sensitive to unique cultural influences surrounding gender, race, and rurality; and issues related to motivation are threaded throughout the program.

Behavioral: GameDay Ready Program; 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. Each weekly session will be led by a trained facilitator and will include a brief educational component, participant updates on progress, group discussions about overcoming barriers, supervised competitive physical activities, and goal setting for the upcoming week. Educational content will be reinforced and social support will be provided during warmup and cool down walks. Participants will be asked to set behavioral goals toward increasing physical activity and improving dietary habits and will be provided resources to self-monitor their activity, dietary intake, and weight.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Interest	Number of people expressing interest in the study	Up to week 1
Eligibility	Number of men who express interest in the study and are eligible.	Up to week 1
Time to Enroll	Length of time needed to enroll the desired sample size (length of time reflects when recruitment was initiated until study launch)	Up to week 1
Attendance	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.	Baseline to 3 months
Attrition	Number and percentage of enrolled men who withdraw from the study	Baseline to 3 and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Weight	Participant body weight measured using a portable, professional-grade scale	Change from baseline to 3 and 6 months
Change in Body Mass Index	Weight in kilograms divided by height in meters squared	Change from baseline to 3 and 6 months
Change in Waist Circumference	Measured using an anthropometric measuring tape	Change from baseline to 3 and 6 months
Change in Blood Pressure	Systolic and diastolic blood pressure measured using an a portable automatic monitor	Change from baseline to 3 and 6 months
Change in Moderate-to-vigorous Physical Activity	Average minutes of moderate-to-vigorous physical activity measured over 7 consecutive days using an accelerometer	Change from baseline to 3 and 6 months
Dietary Intake	Caloric intake, saturated fat intake, fruit and vegetable intake measured using 3-day 24 hour dietary recalls	Change from baseline to 3 and 6 months
Social Support for Diet and Physical Activity	Measured using validated scales developed by Sallis et al.	Change from baseline to 3 and 6 months
Environmental Support for Physical Activity	Measured using the 33-item Rural Active Living Perceived Environmental Support Scale	Change from baseline to 3 and 6 months
Motivation for Weight Loss	Measured using an 8-item Weight Control Motivation Scale	Change from baseline to 3 and 6 months
Motivation for Healthy Eating	Measured using a 15-item scale of the Treatment Self-Regulation Questionnaire	Change from baseline to 3 and 6 months
Motivation for Physical Activity	Measured using the 24-item Motivation for Exercise Scale	Change from baseline to 3 and 6 months
Self-efficacy for Exercise	Measured using a 16-item Self-Efficacy for Exercise Scale	Change from baseline to 3 and 6 months
Neighborhood Surroundings	Measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale	Change from baseline to 3 and 6 months
Neighborhood Safety	Measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale	Change from baseline to 3 and 6 months
Relatedness to Others in Physical Activity	Measured using a 6-item scale developed by Wilson & Bengoechea	Change from baseline to 3 and 6 months

Collaborators and Investigators

• Sponsor: University of South Carolina
• Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
• Investigators: Principal Investigator: Demetrius A Abshire, PhD, University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2022
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pro00116611; K23MD013899 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data can be shared upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No