Rural Engagement in Primary Care for Optimizing Weight Reduction

Study Overview
=================
Brief Summary
-----------------
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.

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

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

Conditions
-----------------
Obesity

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fee-for-Service Model (FFS, In clinic individual visits)<br>Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits. | Behavioral: Fee-for-Service Model (FFS, In clinic individual visits)<br>* To be performed by participant's doctor or other healthcare professional in their doctor's office.<br>* Other names: Individual weight management counseling;|
| Active Comparator: Patient Centered Medical Home (PCMH, In clinic group visits)<br>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. | Behavioral: Patient Centered Medical Home (PCMH, In clinic group visits)<br>* To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.<br>* Other names: Group weight management counseling (in-person and telephone);|
| Active Comparator: Disease Management (DM, Phone group visits)<br>Participants will take part in group weight-management counseling by telephone. | Behavioral: Disease Management (DM, Phone group visits)<br>* To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.<br>* Other names: Group weight management counseling (telephone);|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 6, 18 and 24 months | 
| Mean Weight Change Over 24 Months; Adjusted | 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). Adjusted for affiliation, sex, race/ethnicity, education, diabetes, cardiovascular disease, and travel time to clinic. | Baseline and 6, 18 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Baseline and 6, 18 and 24 months | 
| Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation | Mean change in diastolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation. | Baseline and 6, 18 and 24 months | 
| Mean Change in Fasting Glucose; Unadjusted Except for Affiliation | Mean change in fasting glucose will be compared across all treatment arms; unadjusted except for affiliation. | Baseline and 6 and 24 months | 
| Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation | Mean change in fasting cholesterol will be compared across all treatment arms; unadjusted except for affiliation. | Baseline and 6 and 24 months | 
| Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation | Mean change in fasting triglycerides will be compared across all treatment arms; unadjusted except for affiliation. | Baseline and 6 and 24 months | 
| Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation | Mean change in fasting low density lipoprotein (LDL) will be compared across all treatment arms; unadjusted except for affiliation. | Baseline and 6 and 24 months | 
| Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation | Mean change in fasting high density lipoprotein (HDL) will be compared across all treatment arms; unadjusted except for affiliation. | Baseline and 6 and 24 months | 
| Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Change in physical quality of life score, measured by SF-12. The Short Form Health Survey (SF-12) is a general quality of life measure with mental functioning and physical functioning summary scores. Each is scored from 0 to 100 with higher scores representing better functioning. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation. | Baseline and 6 and 24 months | 
| Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation | Mean change in mental quality of life score, measured by SF-12. The Short Form Health Survey (SF-12) is a general quality of life measure with mental functioning and physical functioning summary scores. Each is scored from 0 to 100 with higher scores representing better functioning. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation. | Baseline and 6 and 24 months | 
| Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation | The Impact of Weight on Quality of Life-Lite (IWQOL-L) measure consists of a total score and five subscales--physical function, self-esteem, sexual life, public distress, and work. The total score ranges from 0 to 100 with higher scores indicating better quality of life. Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation. | Baseline and 6 and 24 months | 
| Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation | Measured using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 (better) to 21 (worse). Measures will be collected at baseline, 6 months and 24 months. Unadjusted Except for Affiliation. | Baseline and 6 and 24 months | 
| Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation | Mean change in stress measured using the Perceived Stress Scale (PSS). Scores range from 0 to 40. Higher numbers represent greater levels of stress. Measures will be collected at baseline, 6 months, 18 months and 24 months. Unadjusted except for affiliation. | Baseline and 6, 18 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss, Weight management, Diabetes, Heart disease