Clinical trial NCT02456636: Rural Engagement in Primary Care for Optimizing Weight Reduction
Official title: Rural Engagement in Primary Care for Optimizing Weight Reduction (RE-POWER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Weight loss
Weight management
Diabetes
Heart disease
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-05-28
Enrollment: 1432
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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.

Primary outcomes:
measure: Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation
timeFrame: Baseline and 6, 18 and 24 months
measure: Mean Weight Change Over 24 Months; Adjusted
timeFrame: Baseline and 6, 18 and 24 months
Secondary outcomes:
measure: Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation
timeFrame: Baseline and 6, 18 and 24 months
measure: Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation
timeFrame: Baseline and 6, 18 and 24 months
measure: Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation
timeFrame: Baseline and 6, 18 and 24 months
measure: Mean Change in Fasting Glucose; Unadjusted Except for Affiliation
timeFrame: Baseline and 6 and 24 months
measure: Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation
timeFrame: Baseline and 6 and 24 months
measure: Mean Change in Fasting Triglycerides; Unadjusted Except for Affiliation
timeFrame: Baseline and 6 and 24 months
measure: Mean Change in Fasting Low Density Lipoprotein (LDL); Unadjusted Except for Affiliation
timeFrame: Baseline and 6 and 24 months
measure: Mean Change in Fasting High Density Lipoprotein (HDL); Unadjusted Except for Affiliation
timeFrame: Baseline and 6 and 24 months
measure: Mean Change in Physical Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation
timeFrame: Baseline and 6 and 24 months
measure: Mean Change in Mental Quality of Life Score, Measured by SF-12; Unadjusted Except for Affiliation
timeFrame: Baseline and 6 and 24 months
measure: Mean Change in Total Quality of Life Score Measured by IWQOL-L; Unadjusted Except for Affiliation
timeFrame: Baseline and 6 and 24 months
measure: Mean Change in Quality of Sleep Score Measured by PSQI; Unadjusted Except for Affiliation
timeFrame: Baseline and 6 and 24 months
measure: Mean Change in Stress Measured by PSS; Unadjusted Except for Affiliation
timeFrame: Baseline and 6, 18 and 24 months
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Christie Befort, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.