Rural Engagement in TelemedTeam for Options in Obesity Treatment Solutions

RECRUITING

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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

🗓️ Study Start (Actual) 10 March 2023

🗓️ Primary Completion (Estimated) August 2026

✅ Study Completion (Estimated) August 2026

👥 Enrollment (Estimated) 560

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 Kansas City, Missouri, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 20 Years to 75 Years (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 29 December 2022
First Submitted that Met QC Criteria 24 January 2023
First Posted 2 February 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 7 June 2024
Last Update Posted 10 June 2024
Last Verified June 2024