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

December 2, 2020 updated by: University of Kansas Medical Center

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

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.

Study Overview

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:

  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

Enrollment (Actual)

1432

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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)
Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.
To be performed by participant's doctor or other healthcare professional in their doctor's office.
Other Names:
  • Individual weight management counseling
Active Comparator: Patient Centered Medical Home (PCMH, In clinic group visits)
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.
To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.
Other Names:
  • Group weight management counseling (in-person and telephone)
Active Comparator: Disease Management (DM, Phone group visits)
Participants will take part in group weight-management counseling by telephone.
To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.
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
Time Frame: Baseline and 6, 18 and 24 months
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
Time Frame: Baseline and 6, 18 and 24 months
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
Time Frame: Baseline and 6, 18 and 24 months
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
Time Frame: Baseline and 6, 18 and 24 months
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
Time Frame: Baseline and 6, 18 and 24 months
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
Time Frame: Baseline and 6 and 24 months
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
Time Frame: Baseline and 6 and 24 months
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
Time Frame: Baseline and 6 and 24 months
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
Time Frame: Baseline and 6 and 24 months
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
Time Frame: Baseline and 6 and 24 months
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
Time Frame: Baseline and 6 and 24 months
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
Time Frame: Baseline and 6 and 24 months
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
Time Frame: Baseline and 6 and 24 months
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
Time Frame: Baseline and 6 and 24 months
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
Time Frame: Baseline and 6, 18 and 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2016

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2019

Study Registration Dates

First Submitted

May 26, 2015

First Submitted That Met QC Criteria

May 27, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Actual)

December 7, 2020

Last Update Submitted That Met QC Criteria

December 2, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RE-POWER
  • PCORI-1402-09413 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)
  • STUDY00002654 (Other Identifier: KUMC IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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