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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Physical Inactivity, Diet, Healthy

Intervention / Treatment
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* Behavioral: GameDay Ready Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GameDay Ready Program<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study interest | Number of men expressing interest in the study | Up to week 1 | 
| Eligibility | Number of men who express interest in the study and are eligible or ineligible | Up to week 1 | 
| Time to enroll | Length of time needed to enroll the desired sample size | Up to week 1 | 
| Attendance | Number and proportion of enrolled men who attend each intervention session and total number of sessions | Baseline to 3 months | 
| Attrition | Number and proportion of enrolled men who withdraw from the study | Baseline to 3 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 |