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

University of Kansas

Status: Active, not recruiting

Conditions: Obesity; Obesity, Morbid

Treatments: Behavioral: Local Care + Model; Behavioral: Team Care Model

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05710510

1R01CA268034-01 (U.S. NIH Grant/Contract)

STUDY00147574

Details and patient eligibility

About

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.

Full 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.

Enrollment: 560 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI: >= 30 kg/m2
• Rural resident
• English speaking
• Physician clearance to participate
• Able to walk without assistance
• Seen at least once in their primary care clinic within the past year
• Internet access or smart phone (to access smart scale for weight measurement)

Exclusion criteria

• History of myocardial infarction within last six months
• History of stroke within last six months
• History of new cancer diagnosis within last six months
• History of bariatric surgery within the last two years
• Pregnancy within last 6 months or planned within the next 18 months
• Currently breastfeeding
• End stage renal disease, currently on dialysis, or anticipated dialysis or renal transplant within the next 18 months
• End stage liver disease, or anticipated liver transplant within the next 18 months
• Currently enrolled or planning to enroll in another study where weight loss is targeted or weight fluctuation is expected
• Currently planning to move outside of current provider area, or leave primary care clinic within the next 18 months
• Another household member is already participating in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

560 participants in 2 patient groups

Local Care + Model

Active Comparator group

Description:

Quarterly clinic visits with a local primary care provider

Treatment:

Behavioral: Local Care + Model

Team Care Model

Active Comparator group

Description:

An intensive group lifestyle intervention led by a lifestyle coach via Zoom, paired with quarterly clinic visits with a local primary care provider and the lifestyle coach, the coach joining via telemedicine.

Treatment:

Behavioral: Team Care Model