"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

Trial Summary

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.

What data supports the effectiveness of the 'GameDay Ready' treatment for obesity?

The systematic review of eHealth interventions suggests that using technology to promote physical activity can be effective for adults with obesity. Additionally, proactive marketing strategies have been shown to successfully recruit participants to obesity prevention programs, which may enhance the reach and impact of treatments like 'GameDay Ready'. ^{1 2 3 4 5}

What makes the 'GameDay Ready' treatment for obesity unique?

The 'GameDay Ready' program is unique because it combines walking, general health education, and a specific treatment approach, potentially addressing obesity-specific barriers to physical activity, which are often overlooked in other interventions. ^{2 6 7 8 9}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of eHealth Interventions to Promote Physical Activity in Adults with Obesity or Overweight. [2023]

2. Australia pubmed.ncbi.nlm.nih.gov

Piloting proactive marketing to recruit disadvantaged adults to a community-wide obesity prevention program. [2016]

3. England pubmed.ncbi.nlm.nih.gov

A mixed methods approach to investigating physical activity in people with obesity participating in a chronic care programme awaiting total knee or hip arthroplasty. [2023]

4. Ireland pubmed.ncbi.nlm.nih.gov

Optimizing acceptability and feasibility of an evidence-based behavioral intervention for obese adults with obesity-related co-morbidities or additional risk factors for co-morbidities: an open-pilot intervention study in secondary care. [2022]

5. United States 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. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy of a novel web-based physical activity intervention in adults with overweight/obesity: A pilot randomized controlled trial. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Leader Behaviors, Group Cohesion, and Participation in a Walking Group Program. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a workplace treadmill desk intervention: a randomized controlled trial. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Exercise Adherence in Hispanic Adolescents with Obesity or Type 2 Diabetes. [2022]