ObesityNCT05970042
Investigating the Effects of the "GameDay Ready" Behavioral Weight Management Program for Black Men Living in the Rural South
A study testing GameDay Ready and Walking and General Health Education in people with Obesity, run by University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- GameDay Ready and Walking and General Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2023to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of South Carolina
Columbia, South Carolina, 29208
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- GameDay Ready, Walking and General Health Education
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GameDay ReadyBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| GameDay Ready Program | Experimental | GameDay Ready is a 12-week, group-based behavioral weight management program. Receives: Behavioral: GameDay Ready |
| Walking and General Health Education Program | Active comparator | The walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men. Receives: Behavioral: Walking and General Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Secondary outcomes (15)
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Waist circumference (WC)
Participants' WC will be measured using anthropometric measuring tape. Changes in WC will be compared between the intervention and comparison programs.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
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.
Measured: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start4 Aug 2023
- Primary completion23 Mar 2026
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Demetrius Abshire, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970042
- Sponsor's protocol ID
- Pro00127414
- Other IDs
- 5K23MD013899
- Status last verified
- May 2026
- First submitted
- 24 Jul 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be shared upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American Men Living in the Rural South
- ClinicalTrials.gov ID
- NCT05970042
- Acronym / sponsor ID
- Pro00127414
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GameDay Ready Program | Experimental | Behavioral: GameDay ReadyGameDay Ready is a 12-week, group-based behavioral weight management program. |
| Walking and General Health Education Program | Active comparator | Behavioral: Walking and General Health EducationThe walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GameDay ReadyGameDay 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. | Behavioural | GameDay Ready Program |
| Walking and General Health EducationParticipants 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. | Behavioural | Walking and General Health Education Program |
Primary outcome
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.
15 secondary outcomes
Body mass index (BMI)
Time frame: 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
Blood pressure (BP)
Time frame: 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
Fruit and vegetable consumption
Time frame: 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
Whole grain consumption
Time frame: 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
Perceived environmental support for physical activity
Time frame: 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 healthy eating
Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Motivation for physical activity
Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Exercise self-efficacy
Time frame: 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
Perceived stress
Time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Individual participant dataSharing planned: Yes. Data can be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GameDay Ready and Walking and General Health Education in people with Obesity, run by University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: Baseline, post-intervention (12 weeks), and 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.