N/A
N=1,432
Rural Engagement in Primary Care for Optimizing Weight Reduction
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02456636 ↗Enrolled (actual)
1,432
Serious AEs
18.4%
Results posted
Jul 2020
Primary outcome: Primary: Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation — -5.73; -8.34; -7.72; -3.35 kg — p=.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Fee-for-Service Model (FFS, In clinic individual visits) (Behavioral); Patient Centered Medical Home (PCMH, In clinic group visits) (Behavioral); Disease Management (DM, Phone group visits) (Behavioral)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation |
-5.73; -8.34; -7.72; -3.35; -5.58; -5.17 | .025 sig |
| PRIMARY Mean Weight Change Over 24 Months; Adjusted |
-6.01; -8.62; -7.97; -3.65; -5.84; -5.44 | .025 sig |
| SECONDARY Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation |
-5.58; -8.20; -7.52; -3.23; -5.47; -5.06 | — |
| SECONDARY Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation |
-2.41; -2.08; -2.27; -0.27; -0.10; -1.28 | — |
| SECONDARY Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation |
-2.23; -2.42; -2.02; -1.03; -1.97; -0.49 | — |
| SECONDARY Mean Change in Fasting Glucose; Unadjusted Except for Affiliation |
-1.69; -3.71; -4.48; 3.07; 0.94; 0.29 | — |
| SECONDARY Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation |
-6.20; -8.22; -5.89; -3.85; -1.69; -0.74 | — |
| SECONDARY Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation |
-12.61; -25.39; -18.61; -0.46; -19.17; -10.40 | — |
| SECONDARY Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation |
-3.38; -4.05; -2.94; -5.26; -1.38; -0.83 | — |
| SECONDARY Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation |
0.25; 0.76; -0.05; 1.32; 1.88; 2.12 | — |
| SECONDARY Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation |
1.71; 2.69; 2.61; 1.39; 1.50; 0.89 | — |
| SECONDARY Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation |
1.49; 1.92; -0.09; 0.89; 0.93; -0.07 | — |
| SECONDARY Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation |
11.16; 11.70; 11.73; 11.83; 11.32; 11.23 | — |
| SECONDARY Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation |
-0.70; -0.90; -0.97; -0.62; -0.75; -0.56 | — |
| SECONDARY Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation |
0.03; -0.33; -0.26; 0.53; 0.46; 0.69 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT02456636). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.