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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05530980
• Other study ID #: Pro00116611
• Secondary ID: K23MD013899
• Status: Completed
• Phase: N/A
• Start date: August 19, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: January 2024
• Source: University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet, Healthy
• Obesity
• Physical Inactivity

Intervention

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.

Locations

Country	Name	City	State
United States	University of South Carolina	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Carolina	National Institute on Minority Health and Health Disparities (NIMHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Interest	Number of people expressing interest in the study	Up to week 1
Primary	Eligibility	Number of men who express interest in the study and are eligible.	Up to week 1
Primary	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
Primary	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
Primary	Attrition	Number and percentage of enrolled men who withdraw from the study	Baseline to 3 and 6 months
Secondary	Change in Weight	Participant body weight measured using a portable, professional-grade scale	Change from baseline to 3 and 6 months
Secondary	Change in Body Mass Index	Weight in kilograms divided by height in meters squared	Change from baseline to 3 and 6 months
Secondary	Change in Waist Circumference	Measured using an anthropometric measuring tape	Change from baseline to 3 and 6 months
Secondary	Change in Blood Pressure	Systolic and diastolic blood pressure measured using an a portable automatic monitor	Change from baseline to 3 and 6 months
Secondary	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
Secondary	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
Secondary	Social Support for Diet and Physical Activity	Measured using validated scales developed by Sallis et al.	Change from baseline to 3 and 6 months
Secondary	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
Secondary	Motivation for Weight Loss	Measured using an 8-item Weight Control Motivation Scale	Change from baseline to 3 and 6 months
Secondary	Motivation for Healthy Eating	Measured using a 15-item scale of the Treatment Self-Regulation Questionnaire	Change from baseline to 3 and 6 months
Secondary	Motivation for Physical Activity	Measured using the 24-item Motivation for Exercise Scale	Change from baseline to 3 and 6 months
Secondary	Self-efficacy for Exercise	Measured using a 16-item Self-Efficacy for Exercise Scale	Change from baseline to 3 and 6 months
Secondary	Neighborhood Surroundings	Measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale	Change from baseline to 3 and 6 months
Secondary	Neighborhood Safety	Measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale	Change from baseline to 3 and 6 months
Secondary	Relatedness to Others in Physical Activity	Measured using a 6-item scale developed by Wilson & Bengoechea	Change from baseline to 3 and 6 months