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ObesityNCT05530980

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

A study testing GameDay Ready Program in people with Obesity and Physical Inactivity, run by University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Physical Inactivity, Diet, Healthy
What is being tested?
GameDay Ready Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteUnited States
Study dates
19 Aug 2022to 1 Jun 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 25 to 50 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

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 intervention, 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 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of South Carolina

    Columbia, South Carolina, 29208

Other trials in United States

About this study

Official title: Developing a Lifestyle Intervention to Reduce Body Weight for Obese African American 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.

Being tested
GameDay Ready Program
Medical subject headings
Obesity, Sedentary Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GameDay Ready ProgramBehavioural

    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.

Study groups in NCT05530980
Study groupRoleWhat they receive
GameDay Ready ProgramExperimentalThe GameDay Ready Program is a 12-week, football-themed, behavioral weight management intervention that promotes gradual increases in physical activity, reductions in sedentary time, and improvements in dietary habits through education, self-monitoring of physical activity and diet, personalized goal setting, group-based competition, social support, identifying and overcoming barriers, and including physical activity as a substantial component of meeting sessions. The program is sensitive to unique cultural influences surrounding gender, race, and rurality; and issues related to motivation are threaded throughout the program.
Receives: Behavioral: GameDay Ready Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Study Interest

    Number of people expressing interest in the study

    Measured: Up to week 1

  2. Eligibility

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

    Measured: Up to week 1

  3. Time to Enroll

    Length of time needed to enroll the desired sample size (length of time reflects when recruitment was initiated until study launch)

    Measured: Up to week 1

  4. Attendance

    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.

    Measured: Baseline to 3 months

  5. Attrition

    Number and percentage of enrolled men who withdraw from the study

    Measured: Baseline to 3 and 6 months

Secondary outcomes (15)

  1. Change in Weight

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

    Measured: Change from baseline to 3 and 6 months

  2. Change in Body Mass Index

    Weight in kilograms divided by height in meters squared

    Measured: Change from baseline to 3 and 6 months

  3. Change in Waist Circumference

    Measured using an anthropometric measuring tape

    Measured: Change from baseline to 3 and 6 months

  4. Change in Blood Pressure

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

    Measured: Change from baseline to 3 and 6 months

  5. Change in Moderate-to-vigorous Physical Activity

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

    Measured: Change from baseline to 3 and 6 months

  6. Dietary Intake

    Caloric intake, saturated fat intake, fruit and vegetable intake measured using 3-day 24 hour dietary recalls

    Measured: Change from baseline to 3 and 6 months

  7. Social Support for Diet and Physical Activity

    Measured using validated scales developed by Sallis et al.

    Measured: Change from baseline to 3 and 6 months

  8. Environmental Support for Physical Activity

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

    Measured: Change from baseline to 3 and 6 months

  9. Motivation for Weight Loss

    Measured using an 8-item Weight Control Motivation Scale

    Measured: Change from baseline to 3 and 6 months

  10. Motivation for Healthy Eating

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

    Measured: Change from baseline to 3 and 6 months

  11. Motivation for Physical Activity

    Measured using the 24-item Motivation for Exercise Scale

    Measured: Change from baseline to 3 and 6 months

  12. Self-efficacy for Exercise

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

    Measured: Change from baseline to 3 and 6 months

  13. Neighborhood Surroundings

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

    Measured: Change from baseline to 3 and 6 months

  14. Neighborhood Safety

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

    Measured: Change from baseline to 3 and 6 months

  15. Relatedness to Others in Physical Activity

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

    Measured: Change from baseline to 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2022
  2. Study start19 Aug 2022
  3. Primary completion1 Apr 2023
  4. Study completion1 Jun 2023

Resources

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
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05530980
Sponsor's protocol ID
Pro00116611
Other IDs
K23MD013899
Status last verified
Jan 2024
First submitted
30 Aug 2022
Last updated
2 Feb 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data can be shared upon reasonable request.

Questions about this trial

What is this clinical trial studying?

A study testing GameDay Ready Program in people with Obesity and Physical Inactivity, 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 3 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: finished, as of the sponsor's last update on 2 Feb 2024. 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?

Yes. Results are posted in the registry (first posted 2 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Study Interest (time frame: Up to week 1). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05530980.

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 2 Feb 2024.

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Clinical Trial NCT05530980 | AzTrials