Rural Engagement in Primary Care for Optimizing Weight Reduction

Obesity Clinical Trial

— RE-POWER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02456636
• Other study ID #: RE-POWER
• Secondary ID: PCORI-1402-09413
• Status: Completed
• Phase: N/A
• Start date: February 15, 2016
• Est. completion date: December 30, 2019

Study information

• Verified date: December 2020
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1432
• Est. completion date: December 30, 2019
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Behavioral:
• Fee-for-Service Model (FFS, In clinic individual visits)
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)
To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.
• Disease Management (DM, Phone group visits)
To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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