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Completed

NCT Number: NCT05530980

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

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.

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Key information

Conditions

Obesity Behavior Body Weight Diet, Healthy Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Inactivity Sedentary Behavior Signs and Symptoms

Age range

25 year–50 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
  • 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

Treatment and study plan

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.

Primary outcomes

  1. Study Interest

    Time frame: Up to week 1

    Number of people expressing interest in the study

  2. Eligibility

    Time frame: Up to week 1

    Number of men who express interest in the study and are eligible.

  3. Time to Enroll

    Time frame: 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)

  4. Attendance

    Time frame: 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.

  5. Attrition

    Time frame: Baseline to 3 and 6 months

    Number and percentage of enrolled men who withdraw from the study

Secondary outcomes

  1. Change in Weight

    Time frame: Change from baseline to 3 and 6 months

    Participant body weight measured using a portable, professional-grade scale

  2. Change in Body Mass Index

    Time frame: Change from baseline to 3 and 6 months

    Weight in kilograms divided by height in meters squared

  3. Change in Waist Circumference

    Time frame: Change from baseline to 3 and 6 months

    Measured using an anthropometric measuring tape

  4. Change in Blood Pressure

    Time frame: Change from baseline to 3 and 6 months

    Systolic and diastolic blood pressure measured using an a portable automatic monitor

  5. Change in Moderate-to-vigorous Physical Activity

    Time frame: Change from baseline to 3 and 6 months

    Average minutes of moderate-to-vigorous physical activity measured over 7 consecutive days using an accelerometer

  6. Dietary Intake

    Time frame: 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

  7. Social Support for Diet and Physical Activity

    Time frame: Change from baseline to 3 and 6 months

    Measured using validated scales developed by Sallis et al.

  8. Environmental Support for Physical Activity

    Time frame: Change from baseline to 3 and 6 months

    Measured using the 33-item Rural Active Living Perceived Environmental Support Scale

  9. Motivation for Weight Loss

    Time frame: Change from baseline to 3 and 6 months

    Measured using an 8-item Weight Control Motivation Scale

  10. Motivation for Healthy Eating

    Time frame: Change from baseline to 3 and 6 months

    Measured using a 15-item scale of the Treatment Self-Regulation Questionnaire

  11. Motivation for Physical Activity

    Time frame: Change from baseline to 3 and 6 months

    Measured using the 24-item Motivation for Exercise Scale

  12. Self-efficacy for Exercise

    Time frame: Change from baseline to 3 and 6 months

    Measured using a 16-item Self-Efficacy for Exercise Scale

  13. Neighborhood Surroundings

    Time frame: Change from baseline to 3 and 6 months

    Measured using the neighborhood surroundings subscale of the Neighborhood Environment Walkability Scale

  14. Neighborhood Safety

    Time frame: Change from baseline to 3 and 6 months

    Measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale

  15. Relatedness to Others in Physical Activity

    Time frame: Change from baseline to 3 and 6 months

    Measured using a 6-item scale developed by Wilson & Bengoechea

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
2022
Primary completion
2023
Study completion
2023
First posted
Sep 7, 2022
Registry last updated
Feb 2, 2024

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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