RECRUITING

Optimal Digital Weight Loss Treatment for Rural Individuals

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Addressing Rural Health Disparities by Optimizing "High Touch" Intervention Components in Digital Obesity Treatment

Quick Facts

Study Start:2024-01-03
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06105957

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * have a body mass index \[BMI\] \> 25-55 kg/m2;
  2. * home address in a zip code classified as non-urban in the USDA Rural-Urban Commuting Area \[RUCA\] codes of 4-10);
  3. * have no physical limitations that prevent walking at a moderate pace for at least 10 minutes without stopping;
  4. * be able to provide informed consent;
  5. * 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);
  6. * complete all screening and baseline questionnaires and activities.
  1. * only one member of a household may participate concurrently.
  2. * 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;
  3. * are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation;
  4. * 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);
  5. * 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.

Contacts and Locations

Study Contact

Teace Markwalter, MPH, CHES
CONTACT
434-297-5874
bdw9cp@virginia.edu
Janna Borden, MS
CONTACT
803-777-3471
jsborden@mailbox.sc.edu

Principal Investigator

Delia West, PhD
PRINCIPAL_INVESTIGATOR
University of South Carolina
Rebecca Krukowski, PhD
PRINCIPAL_INVESTIGATOR
University of Virginia School of Medicine

Study Locations (Sites)

University of South Carolina
Columbia, South Carolina, 29208
United States

Collaborators and Investigators

Sponsor: University of South Carolina

  • Delia West, PhD, PRINCIPAL_INVESTIGATOR, University of South Carolina
  • Rebecca Krukowski, PhD, PRINCIPAL_INVESTIGATOR, University of Virginia School of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-03
Study Completion Date2027-12

Study Record Updates

Study Start Date2024-01-03
Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

  • behavioral weight control
  • weight management
  • online weight loss program

Additional Relevant MeSH Terms

  • Overweight and Obesity