Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06105957

Optimal Digital Weight Loss Treatment for Rural Individuals

Led by University of South Carolina · Updated on 2025-12-23

616

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

U

University of South Carolina

Lead Sponsor

U

University of Virginia

Collaborating Sponsor

AI-Summary

What this Trial Is About

Over 130 million adults in the US experience overweight and obesity, and rural communities experience significantly higher rates of obesity and related chronic diseases. Although lifestyle interventions successfully produce clinically significant weight losses, the availability of weight management programs is limited in rural areas. Digital interventions offer an attractive alternative for delivering lifestyle programs to rural populations. However, in-person behavioral obesity treatment programs achieve better weight losses than digital programs, likely because in-person programs typically include personnel-intensive "high touch" treatment components. Some studies indicate that having a human "behind the curtain" of a digital program through emailed feedback or with the addition of online group sessions can significantly increase weight loss. Therefore, the aims of this study are to increase the public health impact of digital obesity treatment for rural populations by simultaneously investigating 3 "high touch" intervention components. The investigators will conduct a highly efficient experiment with participants residing in non-urban areas recruited online from across the United States. Participants (N=616; 22% racial/ethnic minority; 40% male) will be randomized to: (1) weekly facilitated synchronous group video sessions (yes vs. no); (2) type of self-monitoring feedback received (counselor-crafted vs. pre-scripted); and (3) individual coaching calls (yes vs. no). These components will be layered onto our 24-week evidence-based, interactive digital weight loss program delivered to groups of eligible individuals. Based on the results of the experiment, The investigators will identify an optimized program in which each component (or combination of components) contributes meaningfully (at least 1.5 kg greater weight loss at 6-months) to enhanced weight loss. The investigators will also exploratory analyses of weight trajectories 6-months post-treatment (i.e., at 12-months) to elucidate extended impact of the specific components on weight control. Ultimately, this research will set the stage for confirming the most promising digital behavioral weight loss intervention that can be used without geographic borders to reduce obesity rates among rural residents and provide the evidence needed to establish best practice policies for broadly effective digital approaches to weight control.

CONDITIONS

Official Title

Optimal Digital Weight Loss Treatment for Rural Individuals

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with a body mass index (BMI) between 25 and 55 kg/m2
  • Living in a non-urban area as defined by rural zip codes or federal rural classifications (RUCA code 4-10, CMS Rural Health Clinic Program, or Federal Office of Rural Health Policy)
  • No physical limitations preventing walking at a moderate pace for at least 10 minutes without stopping
  • Able to provide informed consent
  • Have access to a smartphone and a computer or tablet with a video camera and stable internet connection
  • Willing to complete all screening and baseline questionnaires and activities
Not Eligible

You will not qualify if you...

  • Only one member per household may participate at the same time
  • Currently participating in another weight loss program, using weight loss medication, have had bariatric surgery, or lost 10 or more pounds in the last 6 months
  • Pregnant, breastfeeding, less than 6 months postpartum, or planning pregnancy during the study
  • Have a medical condition that affects safety or effectiveness of diet and physical activity weight management (e.g., uncontrolled heart condition, dementia, bulimia nervosa, binge eating disorder, or serious psychiatric problems)
  • Conditions that make it unlikely to follow the intervention independently for 6 months, including difficulty engaging with online materials, providing self-monitoring data, attending video sessions, or completing online questionnaires

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University of South Carolina

Columbia, South Carolina, United States, 29208

Actively Recruiting

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Research Team

T

Teace Markwalter, MPH, CHES

CONTACT

J

Janna Borden, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

8

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