Back to resultsRural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER)
Primary Purpose
Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fee-for-Service Model (FFS, In clinic individual visits)
Patient Centered Medical Home (PCMH, In clinic group visits)
Disease Management (DM, Phone group visits)
Sponsored by
About this trial
This is an interventional treatment trial for Obesity focused on measuring Weight loss, Weight management, Diabetes, Heart disease
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.
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Fee-for-Service Model (FFS, In clinic individual visits)
Patient Centered Medical Home (PCMH, In clinic group visits)
Disease Management (DM, Phone group visits)
Arm Description
Participants will receive individual counseling from their physician or other healthcare professional during regular clinic 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.
Participants will take part in group weight-management counseling by telephone.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT02456636
First Posted
May 26, 2015
Last Updated
December 2, 2020
Sponsor
University of Kansas Medical Center
Collaborators
Patient-Centered Outcomes Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02456636
Brief Title
Rural Engagement in Primary Care for Optimizing Weight Reduction
Acronym
RE-POWER
Official Title
Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
December 30, 2019 (Actual)
Study Completion Date
December 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Patient-Centered Outcomes Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Weight loss, Weight management, Diabetes, Heart disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1432 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fee-for-Service Model (FFS, In clinic individual visits)
Arm Type
Active Comparator
Arm Description
Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.
Arm Title
Patient Centered Medical Home (PCMH, In clinic group visits)
Arm Type
Active Comparator
Arm 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.
Arm Title
Disease Management (DM, Phone group visits)
Arm Type
Active Comparator
Arm Description
Participants will take part in group weight-management counseling by telephone.
Intervention Type
Behavioral
Intervention Name(s)
Fee-for-Service Model (FFS, In clinic individual visits)
Other Intervention Name(s)
Individual weight management counseling
Intervention Description
To be performed by participant's doctor or other healthcare professional in their doctor's office.
Intervention Type
Behavioral
Intervention Name(s)
Patient Centered Medical Home (PCMH, In clinic group visits)
Other Intervention Name(s)
Group weight management counseling (in-person and telephone)
Intervention Description
To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.
Intervention Type
Behavioral
Intervention Name(s)
Disease Management (DM, Phone group visits)
Other Intervention Name(s)
Group weight management counseling (telephone)
Intervention Description
To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.
Primary Outcome Measure Information:
Title
Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation
Description
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
Title
Mean Weight Change Over 24 Months; Adjusted
Description
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.
Time Frame
Baseline and 6, 18 and 24 months
Secondary Outcome Measure Information:
Title
Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation
Description
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
Title
Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation
Description
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
Title
Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation
Description
Mean change in diastolic blood pressure will be compared across all treatment arms; unadjusted except for affiliation.
Time Frame
Baseline and 6, 18 and 24 months
Title
Mean Change in Fasting Glucose; Unadjusted Except for Affiliation
Description
Mean change in fasting glucose will be compared across all treatment arms; unadjusted except for affiliation.
Time Frame
Baseline and 6 and 24 months
Title
Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation
Description
Mean change in fasting cholesterol will be compared across all treatment arms; unadjusted except for affiliation.
Time Frame
Baseline and 6 and 24 months
Title
Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation
Description
Mean change in fasting triglycerides will be compared across all treatment arms; unadjusted except for affiliation.
Time Frame
Baseline and 6 and 24 months
Title
Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation
Description
Mean change in fasting low density lipoprotein (LDL) will be compared across all treatment arms; unadjusted except for affiliation.
Time Frame
Baseline and 6 and 24 months
Title
Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation
Description
Mean change in fasting high density lipoprotein (HDL) will be compared across all treatment arms; unadjusted except for affiliation.
Time Frame
Baseline and 6 and 24 months
Title
Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation
Description
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.
Time Frame
Baseline and 6 and 24 months
Title
Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation
Description
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.
Time Frame
Baseline and 6 and 24 months
Title
Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation
Description
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.
Time Frame
Baseline and 6 and 24 months
Title
Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation
Description
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.
Time Frame
Baseline and 6 and 24 months
Title
Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation
Description
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.
Time Frame
Baseline and 6, 18 and 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christie Befort, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
35398370
Citation
Saint Onge JM, Fagan M, Befort CA. The association between the obesogenic environment and 6-month and 24-month weight change in a rural weight loss intervention trial in the United States. Prev Med. 2022 May;158:107040. doi: 10.1016/j.ypmed.2022.107040. Epub 2022 Apr 7.
Results Reference
derived
PubMed Identifier
35081912
Citation
Tang F, Befort CA, Wick J, Gajewski BJ. Unifying the analysis of continuous and categorical measures of weight loss and incorporating group effect: a secondary re-analysis of a large cluster randomized clinical trial using Bayesian approach. BMC Med Res Methodol. 2022 Jan 26;22(1):28. doi: 10.1186/s12874-021-01499-0.
Results Reference
derived
PubMed Identifier
34714976
Citation
Katzmarzyk PT, Apolzan JW, Gajewski B, Johnson WD, Martin CK, Newton RL Jr, Perri MG, VanWormer JJ, Befort CA. Weight loss in primary care: A pooled analysis of two pragmatic cluster-randomized trials. Obesity (Silver Spring). 2021 Dec;29(12):2044-2054. doi: 10.1002/oby.23292. Epub 2021 Oct 29.
Results Reference
derived
PubMed Identifier
34175347
Citation
Goessl CL, VanWormer JJ, Pathak RD, Ellerbeck EF, Befort CA. Affective disorders, weight change, and patient engagement in a rural behavioral weight loss trial. Prev Med. 2021 Nov;152(Pt 2):106698. doi: 10.1016/j.ypmed.2021.106698. Epub 2021 Jun 24.
Results Reference
derived
PubMed Identifier
33496775
Citation
Befort CA, VanWormer JJ, Desouza C, Ellerbeck EF, Gajewski B, Kimminau KS, Greiner KA, Perri MG, Brown AR, Pathak RD, Huang TT, Eiland L, Drincic A. Effect of Behavioral Therapy With In-Clinic or Telephone Group Visits vs In-Clinic Individual Visits on Weight Loss Among Patients With Obesity in Rural Clinical Practice: A Randomized Clinical Trial. JAMA. 2021 Jan 26;325(4):363-372. doi: 10.1001/jama.2020.25855.
Results Reference
derived
PubMed Identifier
32126987
Citation
Befort CA, Kurz D, VanWormer JJ, Ellerbeck EF. Recruitment and reach in a pragmatic behavioral weight loss randomized controlled trial: implications for real-world primary care practice. BMC Fam Pract. 2020 Mar 3;21(1):47. doi: 10.1186/s12875-020-01117-w.
Results Reference
derived
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Rural Engagement in Primary Care for Optimizing Weight Reduction
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