Clinical trial NCT05710510: Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions
Official title: Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions (RE-TOOL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Obesity, Morbid
Keywords: Weight loss
Weight management
Behavioral intervention
Medical management of obesity
Team care
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-02-02
Enrollment: 560
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percent weight loss at 18 months
timeFrame: 18 months
Secondary outcomes:
measure: Percent weight loss at 6 months
timeFrame: 6 months
measure: Percent weight loss at 12 months
timeFrame: 12 months
measure: Weight loss (kg) at 6 months
timeFrame: 6 months
measure: Weight loss (kg) at 12 months
timeFrame: 12 months
measure: Weight loss (kg) at 18 months
timeFrame: 18 months
measure: Proportion achieving ≥5% weight loss at 6 months
timeFrame: 6 months
measure: Proportion achieving ≥5% weight loss at 12 months
timeFrame: 12 months
measure: Proportion achieving ≥5% weight loss at 18 months
timeFrame: 18 months
measure: Proportion achieving ≥10% weight loss at 6 months
timeFrame: 6 months
measure: Proportion achieving ≥10% weight loss at 12 months
timeFrame: 12 months
measure: Proportion achieving ≥10% weight loss at 18 months
timeFrame: 18 months
measure: Change in diet quality at 6 months
timeFrame: Baseline and 6 months
measure: Change in diet quality at 12 months
timeFrame: Baseline and 12 months
measure: Change in diet quality at 18 months
timeFrame: Baseline and 18 months
measure: Change in physical activity at 6 months
timeFrame: Baseline and 6 months
measure: Change in physical activity at 12 months
timeFrame: Baseline and 12 months
measure: Change in physical activity at 18 months
timeFrame: Baseline and 18 months
measure: Change in physical quality of life at 6 months
timeFrame: Baseline and 6 months
measure: Change in physical quality of life at 12 months
timeFrame: Baseline and 12 months
measure: Change in physical quality of life at 18 months
timeFrame: Baseline and 18 months
measure: Change in mental quality of life at 6 months
timeFrame: Baseline and 6 months
measure: Change in mental quality of life at 12 months
timeFrame: Baseline and 12 months
measure: Change in mental quality of life at 18 months
timeFrame: Baseline and 18 months
measure: Change in weight-related quality of life at 6 months
timeFrame: Baseline and 6 months
measure: Change in weight-related quality of life at 12 months
timeFrame: Baseline and 12 months
measure: Change in weight-related quality of life at 18 months
timeFrame: Baseline and 18 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Christie Befort, PhD
role: PRINCIPAL_INVESTIGATOR
References: