Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions

NCT05710510 | Active Not Recruiting DMC

• 2 other identifiers: STUDY001475741R01CA268034-01
• Study Type: interventional
• Target: 560
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Obesity, Morbid

Keywords

Weight loss; Weight management; Behavioral intervention; Medical management of obesity; Team care

Outcome Measures

Primary Outcomes (1)

• Percent weight loss at 18 months

  Mean percent weight loss at 18 months; unadjusted

  18 months

Secondary Outcomes (26)

• Percent weight loss at 6 months

  6 months

• Percent weight loss at 12 months

  12 months

• Weight loss (kg) at 6 months

  6 months

• Weight loss (kg) at 12 months

  12 months

• Weight loss (kg) at 18 months

  18 months

Study Arms (2)

Local Care + Model

ACTIVE COMPARATOR

Quarterly clinic visits with a local primary care provider

Behavioral: Local Care + Model

Team Care Model

ACTIVE COMPARATOR

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.

Behavioral: Team Care Model

Interventions

Local Care + Model BEHAVIORAL

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.

Local Care + Model

Team Care Model BEHAVIORAL

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.

Team Care Model

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

Location

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Weight Loss

Interventions

Models, Biological

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Models, Theoretical; Investigative Techniques

Study Officials

• Christie Befort, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: February 2, 2023
• Study Start: March 10, 2023
• Primary Completion (Estimated): October 27, 2026
• Study Completion (Estimated): October 27, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Within 30 days of publication of the primary outcome paper
• Access Criteria: upon email request to the Principal Investigator

Locations

US (1)