Digital weight loss program for rural individuals
Addressing Rural Health Disparities by Optimizing "High Touch" Intervention Components in Digital Obesity Treatment
This study tests a digital weight loss program for people living in rural areas to see if it helps them lose weight through online group sessions and personal coaching.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 616 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of South Carolina Academic / other |
| Locations | 1 site (Columbia, South Carolina) |
| Trial ID | NCT06105957 on ClinicalTrials.gov |
What this trial studies
This study aims to improve weight management for rural populations by implementing a digital weight loss program that includes facilitated weekly group sessions, personalized feedback from counselors, and individual coaching calls. Given the higher rates of obesity in rural areas and the limited availability of in-person programs, this intervention seeks to combine the benefits of digital accessibility with the effectiveness of human interaction. Participants will engage in a structured program designed to promote significant weight loss through behavioral changes and support. The study will assess the impact of these combined approaches on weight loss outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults with a BMI between 25-55 who live in non-urban areas and have access to the necessary technology.
Not a fit: Patients who are currently participating in another weight loss program or have recently lost significant weight may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide an effective weight loss solution for individuals in rural areas, improving their health and quality of life.
How similar studies have performed: Previous studies have shown that incorporating human interaction into digital weight loss programs can enhance outcomes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * have a body mass index \[BMI\] \> 25-55 kg/m2; * home address in a zip code classified as non-urban; classification of an individual as living in a non-urban area will be determined by meeting any one of the following criteria: (1) having a home address corresponding to a Rural-Urban Commuting Area \[RUCA\] code of 4-10); (2) qualifying as rural under the Centers for Medicare and Medicaid Services Rural Health Clinic Program based on the 2010 or 2020 Census Bureau data; or (3) meeting the definition of rural from the Federal Office of Rural Health Policy; * have no physical limitations that prevent walking at a moderate pace for at least 10 minutes without stopping; * be able to provide informed consent; * have access to a smartphone and a computer or tablet with a video camera and stable access to the Internet (at home or work or some other stable source of access); * complete all screening and baseline questionnaires and activities. Exclusion Criteria: * only one member of a household may participate concurrently. * currently participating in another weight loss program, taking a weight loss medication, have a history of bariatric surgery, or lost ≥ 10 pounds during the past 6-months; * are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation; * report a medical condition that would affect the safety and/or efficacy of a weight management program involving diet and physical activity (e.g., uncontrolled heart condition, dementia, bulimia nervosa or binge eating disorder, or other significant psychiatric problems); * or report conditions that in the judgment of the one of the Principal Investigators (MPIs) would render them unlikely to be able to independently follow the intervention protocol for 6 months, including conditions which might comprise their ability to engage independently with the intervention website materials, provide self-monitoring information on a smartphone app, attend Zoom video group or individual sessions at the available times (if randomized to receive these treatment components), and complete online questionnaires.
Where this trial is running
Columbia, South Carolina
- University of South Carolina — Columbia, South Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Delia West, PhD — University of South Carolina
- Study coordinator: Teace Markwalter, MPH, CHES
- Email: bdw9cp@virginia.edu
- Phone: 434-297-5874
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.