Recruiting

Digital Weight Loss

Sponsor:

University of South Carolina

Code:

NCT06105957

Conditions

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Core

Facilitated Weekly Group Sessions

Counselor Crafted Feedback

Individual Coaching Calls

Pre-Scripted Feedback

Study Details

Brief 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.

Conditions

Overweight and Obesity

Study ID

NCT06105957

Start date

Jan 3, 2024

Status verified date

Dec, 2025

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

616 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback+Individual Coaching Calls

Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.

Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.

Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message.

Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss.

experimental: Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback

Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.

Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.

Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement.

experimental: Core+Facilitated Weekly Group Sessions+Pre-Scripted Feedback+Individual Coaching Calls

Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.

Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.

Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement.

Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss.

experimental: Core+Facilitated Weekly Group Sessions+Counselor Crafted Feedback

Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.

Behavioral: Facilitated Weekly Group Sessions Participants will receive 24, 60-minute facilitated online video-conference-based weekly group sessions.

Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message.

experimental: Core+ Counselor Crafted Feedback+Individual Coaching Calls

Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.

Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message.

Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss.

experimental: Core+ Counselor Crafted Feedback

Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.

Behavioral: Counselor Crafted Feedback Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message.

experimental: Core+Pre-Scripted Feedback+Individual Coaching Calls

Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.

Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement.

Behavioral: Individual Coaching Calls Participants will receive 3 30-minute online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss.

experimental: Core+Pre-Scripted Feedback

Behavioral: Core The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals.

Behavioral: Pre-Scripted Feedback Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring related to diet monitoring, physical activity, and self-weighing, as well as on weekly module engagement.

Interventions

Core

The core intervention will include 24 online weekly behavioral modules, an online interactive discussion board, a physical activity tracker, an e-scale with recommendations for daily self-weighing, dietary self-monitoring via an app, as well as weekly calorie and physical activity goals. Weekly tips and discussion board postings invite participants to apply skills introduced in the modules and prompt interaction and social support within the closed group which starts the program simultaneously.

Facilitated Weekly Group Sessions

Participants will receive 24 facilitated online video-conference-based weekly group sessions. These groups will be 60 minutes long and will be facilitated by a trained professional, who reinforces the information and behavioral strategies introduced in the weekly modules, elicits the experiences of participants in applying behavioral skills to establish new diet and exercise habits, and guides problem solving. Group cohesion to offer social support is promoted.

Counselor Crafted Feedback

Participants will receive up to 24 weekly messages that are crafted by a trained professional based on their dietary, physical activity, and weight monitoring for the week as well as their completion of online modules, to construct an individualized feedback message. The emailed feedback will provide positive reinforcement for successful goal achievement, identify possible areas for improvement, and suggest possible strategies for identified challenges.

Individual Coaching Calls

Participants will receive 3 online one-on-one coaching calls to focus on identifying and addressing challenges to successful behavior change and weight loss. The first call will emphasize amplifying motivation and promoting early treatment engagement by establishing rapport, exploring personal reasons for weight loss and lifestyle change, and reinforcing and expanding change talk, and it will occur prior to starting the core program. Subsequent calls will use a motivational interviewing-informed approach to problem solve barriers to self-monitoring, particularly dietary self-monitoring because of the strong role it plays in promoting better weight loss and will occur during the first half of the program, reflecting the critical role of early engagement in the treatment program on long term weight loss success. Coaching calls will be of approximately 30 min duration and will follow a semi-structured interview format.

Pre-Scripted Feedback

Participants will receive up to 24 weekly messages constructed from a bank of pre-scripted messages that align with success, partial success, or absence of self-monitoring within each of the following domains: dietary monitoring, physical activity monitoring, and self-weighing, as well as on weekly module completion. Feedback is automatically generated based on decision algorithms and will be sent from program staff.

Primary outcome measure

  • Change in weight at 6 months [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Teace Markwalter, MPH, CHES

434-297-5874bdw9cp@virginia.edu

Janna Borden, MS

803-777-3471jsborden@mailbox.sc.edu

Locations

University of South Carolina

Recruiting

Columbia, South Carolina, United States, 29208

Contacts

Teace Markwalter, MPH, CHES

866-271-7217bdw9cp@virginia.edu

Janna Borden, MS

866-271-7217jsborden@mailbox.sc.edu

More Information

Sponsor

University of South Carolina

Last update posted

Dec 23, 2025

Last verified

Dec, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Carolina on 2025-12-23.