Optimal Digital Weight Loss Treatment for Rural Individuals

Last updated: October 31, 2024
Sponsor: University of South Carolina
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Obesity

Hypertriglyceridemia

Treatment

Counselor Crafted Feedback

Core

Individual Coaching Calls

Clinical Study ID

NCT06105957
Pro00123003
1R01DK135227-01
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • have a body mass index [BMI] > 25-55 kg/m2;

  • home address in a zip code classified as non-urban in the USDA Rural-UrbanCommuting Area [RUCA] codes of 4-10);

  • have no physical limitations that prevent walking at a moderate pace for atleast 10 minutes without stopping;

  • be able to provide informed consent;

  • have access to a smartphone and a computer or tablet with a video camera andstable access to the Internet (at home or work or some other stable source ofaccess);

  • complete all screening and baseline questionnaires and activities.

Exclusion

Exclusion Criteria:

  • only one member of a household may participate concurrently.

  • currently participating in another weight loss program, taking a weight lossmedication, 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 pregnantduring the time frame of the investigation;

  • report a medical condition that would affect the safety and/or efficacy of a weightmanagement program involving diet and physical activity (e.g., uncontrolled heartcondition, dementia, bulimia nervosa or binge eating disorder, or other significantpsychiatric 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 theintervention protocol for 6 months, including conditions which might comprise theirability to engage independently with the intervention website materials, provideself-monitoring information on a smartphone app, attend Zoom video group orindividual sessions at the available times (if randomized to receive these treatmentcomponents), and complete online questionnaires.

Study Design

Total Participants: 616
Treatment Group(s): 5
Primary Treatment: Counselor Crafted Feedback
Phase:
Study Start date:
January 03, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • University of South Carolina

    Columbia, South Carolina 29208
    United States

    Active - Recruiting

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