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

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ClinicalTrials.gov Identifier: NCT02456636
Recruitment Status : Active, not recruiting
First Posted : May 28, 2015
Last Update Posted : January 24, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Fee-for-Service Model Behavioral: Patient Centered Medical Home Behavioral: Disease Management Not Applicable

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
  2. Group weight-management counseling, both in person and by telephone
  3. Group weight-management counseling by telephone

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER)
Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Fee-for-Service Model
Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.
Behavioral: Fee-for-Service Model
To be performed by participant's doctor or other healthcare professional in their doctor's office.
Other Name: Individual weight-management counseling

Active Comparator: Patient Centered Medical Home
Participants will take part in group weight-management counseling during in-person group visits and then by group telephone calls.
Behavioral: Patient Centered Medical Home
To be performed by a registered dietitian, a nurse or other healthcare professional.
Other Name: Group weight management counseling (in-person and telephone)

Active Comparator: Disease Management
Participants will take part in group weight-management counseling by telephone.
Behavioral: Disease Management
To be preformed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling
Other Name: Group weight management counseling (telephone)




Primary Outcome Measures :
  1. Reduction in Weight at 24 Months [ Time Frame: Change from Baseline to Month 24 ]
    Comparison in weight loss of participants between the three study groups.


Secondary Outcome Measures :
  1. Change in blood pressure [ Time Frame: Change from Baseline to Month 24 ]
  2. Change in fasting glucose and lipids [ Time Frame: Change from Baseline to Month 24 ]
  3. Change in quality of life measured by SF-12 and IWQOL-L [ Time Frame: Change from Baseline to Month 24 ]
    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 31 to 155 with higher scores indicating poorer quality of life. The SF-12 is a general quality of life measures with mental functioning and physical functioning component scores. It is scored from 0 to 100 with higher scores representing better functioning.

  4. Change in quality of sleep measured by PSQI [ Time Frame: Change from Baseline to Month 24 ]
    Measured using the Pittsburgh Sleep Quality Index (PSQI). The total score ranges from 0 (better) to 21 (worse).

  5. Change in stress measured by PSS [ Time Frame: Change from Baseline to Month 24 ]
    Measured using the Perceived Stress Scale (PSS). Scores range from 0 to 40. Higher numbers represent greater levels of stress.



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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Participants must have access to a telephone
  • One individual per household will be permitted to enroll in the study

Exclusion Criteria:

  • History of heart attack, stroke, new cancer diagnosis, bariatric surgery
  • Pregnancy planned within the next two years or currently pregnant or lactating
  • Serious medical conditions where weight loss is contraindicated
  • Medical contraindications will be determined by the patient's primary care physician (PCP), and 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
  • Able to read and understand English

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02456636


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas Medical Center
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Christie Befort, PhD University of Kansas Medical Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT02456636     History of Changes
Other Study ID Numbers: RE-POWER
PCORI-1402-09413 ( Other Grant/Funding Number: Patient-Centered Outcomes Research Institute )
STUDY00002654 ( Other Identifier: KUMC IRB )
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: January 24, 2019
Last Verified: January 2019
Keywords provided by University of Kansas Medical Center:
Weight loss
Weight management
Diabetes
Heart disease
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms