Rural Engagement in Primary Care for Optimizing Weight Reduction
NCT ID: NCT02456636
Last Updated: 2020-12-07
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1432 participants
INTERVENTIONAL
2016-02-15
2019-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fee-for-Service Model (FFS, In clinic individual visits)
Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.
Fee-for-Service Model (FFS, In clinic individual visits)
To be performed by participant's doctor or other healthcare professional in their doctor's office.
Patient Centered Medical Home (PCMH, In clinic group 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.
Patient Centered Medical Home (PCMH, In clinic group visits)
To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.
Disease Management (DM, Phone group visits)
Participants will take part in group weight-management counseling by telephone.
Disease Management (DM, Phone group visits)
To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.
Interventions
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Fee-for-Service Model (FFS, In clinic individual visits)
To be performed by participant's doctor or other healthcare professional in their doctor's office.
Patient Centered Medical Home (PCMH, In clinic group visits)
To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.
Disease Management (DM, Phone group visits)
To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
20 Years
75 Years
ALL
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of Kansas Medical Center
OTHER
Responsible Party
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Principal Investigators
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Christie Befort, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PCORI-1402-09413
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
STUDY00002654
Identifier Type: OTHER
Identifier Source: secondary_id
RE-POWER
Identifier Type: -
Identifier Source: org_study_id