Investigating the Effects of the "GameDay Ready" 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: Recruiting

Administrative data

• NCT number: NCT05970042
• Other study ID #: Pro00127414
• Secondary ID: 5K23MD013899
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: University of South Carolina
• Contact: Demetrius A Abshire, PhD
• Phone: 803-576-6262
• Email: abshired[@]mailbox.sc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This pilot study investigates the effects of a newly developed 12-week weight management program called "GameDay Ready" (compared to a walking and general health education program) for decreasing body weight among Black men who live in the rural South. The researchers expect to see evidence of greater weight loss among participants randomized to receive the "GameDay Ready" program.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Self-identified African American or Black American male

• 25-65 years of age

• BMI 27kg/m2 to =50kg/m2 (those with a BMI >45 will need documented approval by a healthcare provider to participate in the study)

• Live in a rural area of South Carolina and have lived in a rural area for at least 1 year

• Able to speak and understand English

• Willing to be randomized to the intervention or comparison program

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 study, 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 weight loss surgery within the next 6 months

• Have been treated for cancer in the past 12 months (other than non-melanoma skin cancer)

• Weight loss =5% during the past 6 months

• Plans to move to another county in the next 6 months

• Any other perceived physical or mental health-related condition that would preclude participating in a behavioral program designed to promote weight loss

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• GameDay Ready
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. The GameDay Ready program promotes increasing physical activity, reducing sedentary time, and improving dietary habits through education, behavioral self-monitoring, and goal setting. Each 60-minute intervention session includes a brief educational component followed by a group discussion of weekly progress. Following a short warmup walk, participants engage in group-based competitive physical activities and then a short cooldown walk. Participants then set individual and group-based goals for the upcoming week and discuss strategies for overcoming barriers to achieving goals. The program is sensitive to intersectional influences of gender, race, and rurality on health; and strategies to enhance motivation are threaded throughout the program.
• Walking and General Health Education
Participants receiving the comparison program will complete a 12-week walking and general health education program. Group sessions meet once per week at a publicly accessible walking track, and each 60-minute session consists of a brief educational component on a health topic followed by walking and socializing during the remainder of the session.

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
Other	Neighborhood surroundings	Neighborhood surroundings will be measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Other	Neighborhood safety	Neighborhood safety will be measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Primary	Body weight	Participants' body weight will be measured in pounds using a portable, professional-grade scale. Changes in body weight will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Body mass index (BMI)	Participants' body weight will be measured in pounds using a portable, professional-grade scale, and height will be measured using a portable, professional-grade stadiometer. BMI will be computed as weight (lb) / [height (in)]2 x 703. Changes in BMI will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Waist circumference (WC)	Participants' WC will be measured using anthropometric measuring tape. Changes in WC will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Blood pressure (BP)	Participants' systolic and diastolic BP will be measured using an automatic blood pressure machine. Changes in BP will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Moderate-to-vigorous physical activity (MVPA)	Average minutes of MVPA will be measured over 7 consecutive days using research-grade, wrist-worn accelerometers (ActiGraph). Changes in MVPA will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Fruit and vegetable consumption	Fruit and vegetable consumption will be measured using the National Cancer Institute's Dietary Screener Questionnaire that was used in the 2009-2010 National Health and Nutrition Examination Survey. Changes in fruit and vegetable consumption will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Added sugar consumption	Added sugar consumption will be measured using the National Cancer Institute's Dietary Screener Questionnaire that was used in the 2009-2010 National Health and Nutrition Examination Survey. Changes in added sugar consumption will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Whole grain consumption	Whole grain consumption will be measured using the National Cancer Institute's Dietary Screener Questionnaire that was used in the 2009-2010 National Health and Nutrition Examination Survey. Changes in whole grain consumption will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Social support for exercise and diet	Social support for exercise and diet will be measured using validated scales developed by Sallis et al. Changes in social support for exercise and diet will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Perceived environmental support for physical activity	Perceived environmental support for physical activity will be measured using the 33-item Rural Active Living Perceived Environmental Support Scale. Changes in perceived environmental support for physical activity will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Motivation for weight loss	Motivation for weight loss will be measured using an 8-item Weight Control Motivation Scale. Changes in motivation for weight loss will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Motivation for healthy eating	Motivation for healthy eating will be measured using a 15-item scale of the Treatment Self-Regulation Questionnaire. Changes in motivation for healthy eating will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Motivation for physical activity	Motivation for physical activity will be measured using the 24-item Motivation for Exercise Scale. Changes in motivation for physical activity will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Exercise self-efficacy	Exercise self-efficacy will be measured using a 16-item Self-Efficacy for Exercise Scale. Changes in exercise self-efficacy will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Relatedness to others in physical activity	Relatedness to others in physical activity will be measured using a 6-item scale developed by Wilson & Bengoechea. Changes in relatedness to others in physical activity will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary	Perceived stress	Perceived stress will be measured using the 10-item Perceived Stress Scale. Changes in perceived stress will be compared between the intervention and comparison programs.	Baseline, post-intervention (12 weeks), and 3 months post-intervention