Clinical trial NCT06105957: Optimal Digital Weight Loss Treatment for Rural Individuals
Official title: Addressing Rural Health Disparities by Optimizing "High Touch" Intervention Components in Digital Obesity Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Overweight and Obesity
Keywords: behavioral weight control
weight management
online weight loss program
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: University of Virginia
name: University of Vermont
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2023-10-30
Enrollment: 616
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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-Urban Commuting Area \[RUCA\] codes of 4-10);
  * 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.

Primary outcomes:
measure: Change in weight at 6 months
timeFrame: 6 months
Secondary outcomes:
measure: Change in weight at 12 months
timeFrame: 12 months
Other outcomes:
measure: Change in weight at 2 months
timeFrame: 2 months
measure: Days of self-monitoring of body weight
timeFrame: Calculated continuously for 12 months
measure: Days of dietary self-monitoring
timeFrame: Calculated continuously for 12 months
measure: Days of physical activity self-monitoring
timeFrame: Calculated continuously for 12 months
measure: Proportion of interactive, e-learning modules completed
timeFrame: Calculated continuously for 6 months
measure: Proportion of Group Chat Sessions and Individual Coaching calls attended (percentage), for those who are randomized to receive these treatment elements
timeFrame: Calculated continuously for 6 months
measure: Self-regulation
timeFrame: administered at baseline, 6 and 12 months
measure: Supportive Accountability
timeFrame: administered at 2 and 6 months
measure: Problem solving
timeFrame: administered at baseline and 6 months
measure: Motivation
timeFrame: administered at baseline and 2, 6 and 12 months
measure: Social Support for Weight Control Behaviors
timeFrame: administered at baseline and 2, 6 and 12 months
measure: Group Cohesion and Social Support
timeFrame: administered at 2 and 6 months
measure: Cost
timeFrame: Calculated continuously for 6 months
measure: Perceptions of Accountability
timeFrame: administered at 2 and 6 months
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Delia West, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia School of Medicine
name: Rebecca Krukowski, PhD
role: PRINCIPAL_INVESTIGATOR
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