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

Not Applicable

Completed

Conditions: Physical Inactivity
Obesity
Diet, Healthy

Interventions: Behavioral: GameDay Ready Program

Registration Number: NCT05530980

Lead Sponsor: University of South Carolina

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 7

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GameDay Ready Program	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.

Primary Outcome Measures

Name	Time	Method
Study Interest	Up to week 1	Number of people expressing interest in the study
Attendance	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.
Time to Enroll	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)
Attrition	Baseline to 3 and 6 months	Number and percentage of enrolled men who withdraw from the study
Eligibility	Up to week 1	Number of men who express interest in the study and are eligible.

Secondary Outcome Measures

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