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NCT Number: NCT05970042

Investigating the Effects of the "GameDay Ready" Behavioral Weight Management Program for Black Men Living in the Rural South

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

20 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of South Carolina

Columbia, South Carolina, 29208, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identified African American or Black American male
  • 20-70 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

Treatment and study plan

GameDay Ready

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. 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

Behavioral

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.

Primary outcomes

  1. Body weight

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

Secondary outcomes

  1. Body mass index (BMI)

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  2. Waist circumference (WC)

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    Participants' WC will be measured using anthropometric measuring tape. Changes in WC will be compared between the intervention and comparison programs.

  3. Blood pressure (BP)

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  4. Moderate-to-vigorous physical activity (MVPA)

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  5. Fruit and vegetable consumption

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  6. Added sugar consumption

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  7. Whole grain consumption

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  8. Social support for exercise and diet

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  9. Perceived environmental support for physical activity

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  10. Motivation for weight loss

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  11. Motivation for healthy eating

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  12. Motivation for physical activity

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  13. Exercise self-efficacy

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  14. Relatedness to others in physical activity

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

  15. Perceived stress

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    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.

Other outcomes

  1. Neighborhood surroundings

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    Neighborhood surroundings will be measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale.

  2. Neighborhood safety

    Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention

    Neighborhood safety will be measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale.

Sponsors and collaborators

Lead sponsor

University of South Carolina

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2023
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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