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
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Fee-for-Service Model Behavioral: Patient Centered Medical Home Behavioral: Disease Management||Not Applicable|
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
- Group weight-management counseling, both in person and by telephone
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1432 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
- 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.
- Change in blood pressure [ Time Frame: Change from Baseline to Month 24 ]
- Change in fasting glucose and lipids [ Time Frame: Change from Baseline to Month 24 ]
- 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.
- 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).
- 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.
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
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Christie Befort, PhD||University of Kansas Medical Center|