NCT05710510

Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions

Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions (RE-TOOL)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 560 (estimated)
• Sponsor: University of Kansas Medical Center · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare two methods for managing obesity in rural primary care patients. The first method includes quarterly 1:1 meetings with the participant and their primary care provider and the second includes a group lifestyle intervention over Zoom paired with quarterly team meetings with the participant, their primary care provider and their lifestyle coach, the coach joining via Zoom. Investigators will evaluate which method is best at helping participants lose weight over 18 months.

Detailed description

Obesity increases risk for 13 types of cancer and now affects over 40% of the U.S. adult population, with even higher prevalence among rural Americans. Rural residents often lack access to weight control programs and food and physical activity resources that promote healthy lifestyles, especially in small or remote rural areas. It is important for obesity treatment to be offered in rural primary care, yet local resources are often lacking. Medical management by a primary care provider (PCP) during behavioral weight loss is essential to address co-morbid medical conditions, evaluate obesogenic medications, and explore options for guideline-recommended pharmacotherapy and surgical treatment. This study is designed to enhance sustainable access to obesity treatment in rural communities by offering education to local providers on obesity management and integrating team-based care into an obesity treatment model through telemedicine. The two methods of obesity treatment to be studied are: * Local Care + Arm: Quarterly clinic visits with the participants and their local primary care provider * Team Care Arm: An intensive group lifestyle intervention offered by a lifestyle coach via Zoom, paired with quarterly clinic visits with the participant, their local primary care provider and the lifestyle coach, the coach joining via telemedicine. Participants will be in the study about 18 months. Participants in the Local Care + arm will be asked to complete 4 data collection visits and 6 quarterly clinic visits. Participants in the Team Care arm will be asked to complete 4 data collection visits, 30 counseling sessions and 6 quarterly clinic visits.

Conditions

• Obesity
• Obesity, Morbid

Interventions

Type	Name	Description
BEHAVIORAL	Local Care + Model	Local primary care providers receive training in medical management of obesity prior to the start of the participant intervention. Participants receive 6 quarterly clinic visits with their local primary care provider focused on medical management of obesity.
BEHAVIORAL	Team Care Model	Local primary care providers receive training in medical management of obesity prior to the start of the participant intervention. Participants receive an intensive 18-month group lifestyle intervention (30 total sessions) led by a study lifestyle coach via Zoom, and 6 quarterly 1:1 visits via Zoom with their lifestyle coach. Participants also receive 6 quarterly clinic visits with their local primary care provider; the study lifestyle coach joins the visits via telemedicine. All three parties may meet via telemedicine if needed. The group lifestyle intervention is led by obesity treatment specialists with relevant graduate training and experience.

Timeline

• Start date: 2023-03-10
• Primary completion: 2026-10-27
• Completion: 2026-10-27
• First posted: 2023-02-02
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States