- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05970042
Investigating the Effects of the "GameDay Ready" Behavioral Weight Management Program for Black Men Living in the Rural South
December 18, 2023 updated by: Demetrius Abshire, University of South Carolina
Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American 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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Demetrius A Abshire, PhD
- Phone Number: 803-576-6262
- Email: abshired@mailbox.sc.edu
Study Locations
-
-
South Carolina
-
Columbia, South Carolina, United States, 29208
- Recruiting
- University of South Carolina
-
Contact:
- Demetrius A Abshire, PhD
- Phone Number: 803-576-6262
- Email: abshired@mailbox.sc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GameDay Ready Program
GameDay Ready is a 12-week, group-based behavioral weight management 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.
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.
|
Active Comparator: Walking and General Health Education Program
The walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, post-intervention (12 weeks), and 3 months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline, post-intervention (12 weeks), and 3 months post-intervention
|
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.
|
Baseline, post-intervention (12 weeks), and 3 months post-intervention
|
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.
|
Baseline, post-intervention (12 weeks), and 3 months post-intervention
|
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.
|
Baseline, post-intervention (12 weeks), and 3 months post-intervention
|
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.
|
Baseline, post-intervention (12 weeks), and 3 months post-intervention
|
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.
|
Baseline, post-intervention (12 weeks), and 3 months post-intervention
|
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.
|
Baseline, post-intervention (12 weeks), and 3 months post-intervention
|
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.
|
Baseline, post-intervention (12 weeks), and 3 months post-intervention
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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.
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Baseline, post-intervention (12 weeks), and 3 months post-intervention
|
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.
|
Baseline, post-intervention (12 weeks), and 3 months post-intervention
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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.
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Baseline, post-intervention (12 weeks), and 3 months post-intervention
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Motivation for physical activity
Time Frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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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
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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.
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Baseline, post-intervention (12 weeks), and 3 months post-intervention
|
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.
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Baseline, post-intervention (12 weeks), and 3 months post-intervention
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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.
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Baseline, post-intervention (12 weeks), and 3 months post-intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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Baseline, post-intervention (12 weeks), and 3 months post-intervention
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Neighborhood safety
Time Frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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Neighborhood safety will be measured using the neighborhood safety subscale of the Neighborhood Environment Walkability Scale.
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Baseline, post-intervention (12 weeks), and 3 months post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 4, 2023
Primary Completion (Estimated)
February 1, 2024
Study Completion (Estimated)
February 1, 2024
Study Registration Dates
First Submitted
July 24, 2023
First Submitted That Met QC Criteria
July 24, 2023
First Posted (Actual)
August 1, 2023
Study Record Updates
Last Update Posted (Estimated)
December 19, 2023
Last Update Submitted That Met QC Criteria
December 18, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Pro00127414
- 5K23MD013899 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data can be shared upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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