Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER)

University of Kansas

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Patient Centered Medical Home (PCMH, In clinic group visits); Behavioral: Disease Management (DM, Phone group visits); Behavioral: Fee-for-Service Model (FFS, In clinic individual visits)

Study type: Interventional

Funder types: Other

Identifiers

NCT02456636

STUDY00002654 (Other Identifier)

RE-POWER

PCORI-1402-09413 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to compare three methods for managing obesity in rural patients, to see which method will result in patients being able to attain their weight loss goal and maintain that weight loss.

Full description

Nearly 20% of the U.S. population lives in rural communities. Rural residents suffer at a higher rate from obesity and obesity-related illnesses, including diabetes, heart disease, and arthritis. Local primary care physicians are an important resource for treating obesity in rural areas because of a lack of other community resources.

This study is looking at how effective current, real-world primary care treatment models are in helping rural residents lose weight and maintain that weight loss. Physician clinics will be randomized (like picking numbers from a hat) to conduct one of the three methods. The method a participant is part of will depend on the method their physician's clinic is randomized to. The three methods involved in this study are:

1. Individual weight-management counseling in person (in clinic individual visits)
2. Group weight-management counseling, both in person and by telephone; the latter if preferred by the group (in clinic group visits)
3. Group weight-management counseling by telephone (phone group visits)

Participants will be in the study about 24 months. The number of in-person clinic visits and phone calls each participant will be asked to complete depends on the method.

Enrollment: 1,432 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• BMI between 30 kg/m2 and 45 kg/m2.
• Live in a rural location.
• Have clearance from their primary care provider to participate in a diet and exercise weight control intervention.
• Have access to a telephone.
• One individual per household will be permitted to enroll in the study.

Exclusion criteria

• History of heart attack in the last six months, stroke in the last six months, or new cancer diagnosis in the last six months.
• History of bariatric surgery or planning bariatric surgery in the next two years.
• Pregnancy within the last six months or planned within the next two years or currently pregnant or lactating.
• Serious medical conditions where weight loss is contraindicated.
• End stage renal disease or end stage liver disease.
• Other medical contraindications as determined by the patient's primary care physician (PCP); documented PCP clearance will be obtained.
• Participants who are already enrolled in, or planning to enroll in another research study where weight loss is targeted.
• Participants who plan to relocate outside of their provider's service area or who plan to leave their primary care clinic in the next 2 years.
• Unable to read and understand English.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,432 participants in 3 patient groups

Fee-for-Service Model (FFS, In clinic individual visits)

Active Comparator group

Description:

Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.

Treatment:

Behavioral: Fee-for-Service Model (FFS, In clinic individual visits)

Patient Centered Medical Home (PCMH, In clinic group visits)

Active Comparator group

Description:

Participants will take part in group weight-management counseling during in-person group visits; later sessions may be conducted via group telephone calls if the group prefers.

Treatment:

Behavioral: Patient Centered Medical Home (PCMH, In clinic group visits)

Disease Management (DM, Phone group visits)

Active Comparator group

Description:

Participants will take part in group weight-management counseling by telephone.

Treatment:

Behavioral: Disease Management (DM, Phone group visits)