Weight loss intervention using health technology for underserved groups
Managing Obesity by Leveraging Health Information Technology to Lower Cancer Risk
This study is testing if a new weight loss program delivered through a health app can help underserved groups lose more weight than a standard diabetes support program.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Tennessee Academic / other |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT05410353 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of a multicomponent behavioral weight loss intervention delivered through an electronic health record patient portal. It will randomize 250 participants into two groups: one receiving an intensive lifestyle intervention adapted for underserved populations and the other receiving a comparison intervention based on diabetes support and education. The study will be conducted in two stages, starting with formative assessments to optimize the intervention for acceptability, followed by a clinical trial to measure weight loss outcomes after 12 months. The goal is to determine if the technology-based intervention leads to greater weight loss compared to the comparison group.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older who are overweight or obese and from underserved groups with access to the internet.
Not a fit: Patients with recent coronary or cerebrovascular events, uncontrolled psychiatric disorders, or those planning bariatric surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to significant weight loss and improved health outcomes for underserved populations.
How similar studies have performed: Previous studies, such as the Look AHEAD trial, have shown success with similar lifestyle interventions, indicating potential for this adapted approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. are ≥ 16 years old 2. are overweight or obese (BMI ≥ 25 kg/m2) 3. have access to the Internet via the computer or use a cellphone with a data-plan access 4. are patients at one of the participating practice sites 5. are willing to accept a random assignment, and 6. are from an underserved group (racial / ethnic minority, lower socioeconomic status, or reside in a rural location). Exclusion Criteria: 1. coronary or cerebrovascular disease events or vascular procedures within the past 6 months 2. certain medical conditions that put participants at high risk of adverse events or preclude exercising 3. uncontrolled psychiatric disorders 4. current substance abuse, including heavy alcohol use ≥ 5 drinks on the same occasion for ≥ 5 days in the past 30 days 5. a history of amputation or bariatric surgery or are planning to have bariatric surgery within the next 12 months 6. current weight loss medication use 7. malignancy within the last 5 years (except skin cancer) 8. plans to move out of the area during the next year 9. current participation in another clinical trial 10. pregnancy or breast feeding or are planning to become pregnant within the next 12 months, and 11. instances judged by the investigators' and primary care providers' discretion.
Where this trial is running
Memphis, Tennessee
- University of Tennessee Health Science Center / Department of Preventive Medicine — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Karen Johnson, MD — University of Tennessee
- Study coordinator: Julia Graber
- Email: jgraber@uthsc.edu
- Phone: 901-448-1083
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.