Optimal Digital Weight Loss Treatment for Rural Individuals

Part of paid clinical trials in Columbia, South Carolina.

Sponsor
University of South Carolina
Study ID
NCT06105957
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Core — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jan 3, 2024
Status verified
Dec 2025
Primary completion
Feb 28, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
616 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of South CarolinaColumbiaSouth Carolina29208
Teace Markwalter, MPH, CHES
[email protected]
866-271-7217
Janna Borden, MS
[email protected]
866-271-7217

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By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of South Carolina· Columbia, SC

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