Rural Engagement in Primary Care for Optimizing Weight Reduction

University of Kansas Medical Center1,432 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

1,432

Conditions

Obesity

Interventions

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

To be performed by participant's doctor or other healthcare professional in their doctor's office.

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

To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.

Disease Management (DM, Phone group visits)BEHAVIORAL

To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation

Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.

Time frame: Baseline and 6, 18 and 24 months

Mean Weight Change Over 24 Months; Adjusted

Time frame: Baseline and 6, 18 and 24 months

Secondary Outcomes

Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation

Comparison in percent weight loss from baseline of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.

Time frame: Baseline and 6, 18 and 24 months

Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation

Mean change in systolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation.

Time frame: Baseline and 6, 18 and 24 months

Data from ClinicalTrials.gov

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