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

NCT05530980 | Completed Results

• 2 other identifiers: Pro00116611K23MD013899
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Physical Inactivity; Diet, Healthy

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (15)

• Change in Weight

  Change from baseline to 3 and 6 months

• Change in Body Mass Index

  Change from baseline to 3 and 6 months

• Change in Waist Circumference

  Change from baseline to 3 and 6 months

• Change in Blood Pressure

  Change from baseline to 3 and 6 months

• Change in Moderate-to-vigorous Physical Activity

  Change from baseline to 3 and 6 months

Study Arms (1)

GameDay Ready Program

EXPERIMENTAL

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

Interventions

GameDay Ready Program BEHAVIORAL

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.

GameDay Ready Program

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Obesity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Results Point of Contact

• Title: Dr. Demetrius Abshire
• Organization: University of South Carolina College of Nursing

abshired@mailbox.sc.edu

803-576-6262

Study Officials

• Demetrius A Abshire, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 7, 2022
• Study Start: August 19, 2022
• Primary Completion: April 1, 2023
• Study Completion: June 1, 2023
• Last Updated: February 2, 2024
• Results First Posted: February 2, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)