"GameDay Ready" Program for Obesity

Overseen By Demetrius A Abshire, PhD

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of South Carolina

Must not be taking: Weight loss drugs

Disqualifiers: Uncontrolled hypertension, Diabetes, Asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new 12-week weight management program called "GameDay Ready" to help Black men in the rural South lose weight. The trial compares this program to a walking and general health education program to determine which is more effective in reducing body weight. It suits Black men living in rural South Carolina who struggle with obesity and want to lose weight. As an unphased trial, this study allows participants to contribute to valuable research that could lead to more effective weight management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you've taken any weight loss medications or supplements in the 30 days before the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that programs like "GameDay Ready," which focus on weight management through behavior changes, are generally easy for participants to handle. These programs typically involve changes to diet and exercise routines, which are safe for most people. Similar programs have not reported any serious side effects and often encourage gradual changes rather than sudden ones.

The "GameDay Ready" program is part of an early research study and is still being tested. While researchers are interested in its effects on weight loss, they are still gathering information about its long-term safety. However, because the program focuses on behavior and lifestyle, it is less likely to cause harmful effects compared to treatments involving medication or surgery. Participants should always consult their healthcare provider about any concerns before starting a new program. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The "GameDay Ready" program is unique because it combines behavioral weight management strategies with a group-based format, fostering a supportive community environment. Unlike standard obesity treatments that often focus solely on diet or exercise, GameDay Ready emphasizes behavioral change, potentially leading to sustainable weight loss. Researchers are excited about its potential to address obesity by not just focusing on physical health but also enhancing mental and social well-being.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that game-based health programs like "GameDay Ready," one of the programs tested in this trial, can help people lose weight. A review of various studies found that these programs lead to a small but meaningful drop in body mass index (BMI) for overweight individuals, resulting in weight loss. Another study found that attending community-based sessions, similar to the "Walking and General Health Education Program" arm of this trial, also decreased BMI and body weight percentage. These findings suggest that both "GameDay Ready" and the "Walking and General Health Education Program" might effectively support weight loss for trial participants. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Black men aged 25-65 living in rural South Carolina, with a BMI of 27 to ≤50 (approval needed if >45), can join this weight management study. They must speak English and be okay with random program assignment. Exclusions include recent major surgery, other weight loss programs within the last 6 months, uncontrolled hypertension or diabetes, severe asthma, certain musculoskeletal conditions, and some medication use.

Inclusion Criteria

Willing to be randomized to the intervention or comparison program

Self-identified African American or Black American male

Live in a rural area of South Carolina and have lived in a rural area for at least 1 year

Exclusion Criteria

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)

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 12-week weight management program called 'GameDay Ready' or a walking and general health education program

12 weeks

Weekly group sessions

Follow-up

Participants are monitored for changes in body weight, blood pressure, and other health metrics post-intervention

3 months

What Are the Treatments Tested in This Trial?

Interventions

• GameDay Ready
• Walking and General Health Education

Trial Overview The 'GameDay Ready' program is being tested against a walking and general health education program for its effectiveness in reducing body weight over a period of 12 weeks among Black men residing in the rural South who are part of the study.

How Is the Trial Designed?

Group I: GameDay Ready Program Experimental Treatment 1 Intervention

GameDay Ready is a 12-week, group-based behavioral weight management program.

Group II: Walking and General Health Education Program Active Control 1 Intervention

The walking and general health education program is a 12-week, group-based program that addresses common chronic health conditions that affect men.

Who Is Running the Clinical Trial?

University of South Carolina

Lead Sponsor

Trials

233

Recruited

122,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

A systematic review of 18 studies found that eHealth interventions, such as web-based programs and physical activity monitors, can effectively promote physical activity in adults with obesity.

The review highlighted that techniques like self-monitoring, which are effective in traditional face-to-face settings, can be more efficiently implemented through eHealth technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of eHealth Interventions to Promote Physical Activity in Adults with Obesity or Overweight. Lee, S., Patel, P., Myers, ND., et al.[2023]

A tailored, telephone-based physical activity coaching intervention significantly reduced Body Mass Index (BMI) by 7.4% in a higher support group of severely obese women, while the other groups either increased or showed minimal change in BMI.

Both the higher and lower support groups experienced substantial increases in physical activity (39% and 30%, respectively), demonstrating that coaching can effectively enhance physical activity levels in this population compared to a decline in the awareness group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial to increase physical activity and reduce obesity in a predominantly African American group of women with mobility disabilities and severe obesity. Rimmer, JH., Rauworth, A., Wang, E., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05970042

Study Details | NCT05970042 | Investigating the Effects of ... The researchers expect to see evidence of greater weight loss among participants randomized to receive the "GameDay Ready" program. Official Title. Developing a ...

2. trialx.com trialx.com/clinical-trials/listings/227587/investigating-the-effects-of-the-gameday-ready-behavioral-weight-management-program-for-black-men-living-in-the-rural-south/?&geo_lat=34.0004&geo_lng=-81.0334&radius=10&place=Columbia&user_country=United%20States

Investigating the Effects of the "GameDay Ready ... The researchers expect to see evidence of greater weight loss among participants randomized to receive the "GameDay Ready" program. Eligibility.

3. liebertpub.com liebertpub.com/doi/10.1089/chi.2017.0250

Impact of Game-Based Health Promotion Programs on ... All studies included in the review found that game-based interventions had a positive impact on reducing weight and BMI among participants. However, several ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3728727/

Evaluation of a Community-Based Weight Management ... For each nutrition group attended, there were significant decreases in BMI (−0.07 kg/m2 per month; p<0.001), percent overweight (−0.002%/month; p<0.001) and BMI ...

5. researchgate.net researchgate.net/publication/321381362_Impact_of_Game-Based_Health_Promotion_Programs_on_Body_Mass_Index_in_OverweightObese_Children_and_Adolescents_A_Systematic_Review_and_Meta-Analysis_of_Randomized_Controlled_Trials

A Systematic Review and Meta-Analysis of Randomized ... ... Game-based health interventions produce small but significant BMI reductions in overweight/obese youth [42] , with multicomponent approaches ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05970042?cond=Obesity&term=weight-loss%20program;%20weight%20management%20program&aggFilters=funderType:nih%20fed,status:rec&rank=8

Investigating the Effects of the "GameDay Ready ... This pilot study investigates the effects of a newly developed 12-week weight management program called "GameDay Ready" (compared to a walking and general ...

7. trialstoday.org trialstoday.org/trial/NCT05970042

Investigating the Effects of the "GameDay Ready ... This pilot study investigates the effects of a newly developed 12-week weight management program called "GameDay Ready" (compared to a walking ...

8. allclinicaltrials.com allclinicaltrials.com/study/NCT05970042

Investigating the Effects of the "GameDay Ready" ... This pilot study investigates the effects of a newly developed 12-week weight management program called "GameDay Ready" (compared to a walking and general ...

9. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05530980?keyword=%22Inactivity%22

San Mateo Clinical Trial GameDay Ready The primary objective of this study is to test the feasibility and acceptability of a 12-week behavioral weight management intervention adapted for Black ...