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Purpose

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

Eligibility

Eligible Ages
Between 20 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Local Care + Model 		Quarterly clinic visits with a local primary care provider
  • 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.
Active Comparator
Team Care Model 		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
    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.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Missouri 66160
Contact:
Stacy McCrea-Robertson, MS
913-945-6941
smccrea-robertson@kumc.edu

More Details

Status
Recruiting
Sponsor
University of Kansas Medical Center

Study Contact

Stacy J McCrea-Robertson, MS
9139456941
smccrea-robertson@kumc.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.