Rural Engagement in Primary Care for Optimizing Weight Reduction

NCT02456636 | Completed Results DMC

• 3 other identifiers: RE-POWERPCORI-1402-09413STUDY00002654
• Study Type: interventional
• Target: 1,432
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Weight loss; Weight management; Diabetes; Heart disease

Outcome Measures

Primary Outcomes (2)

• Mean Weight Change Over 24 Months; Unadjusted Except for Affiliation

  Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Unadjusted except for affiliation.

  Baseline and 6, 18 and 24 months

• Mean Weight Change Over 24 Months; Adjusted

  Mean weight change (kg) of participants between the three study groups. Weight loss at 24 months, and all relevant study visits in between, will be compared 1) between PCMH (in clinic group visits) versus FFS (in clinic individual visits), 2) between DM (phone group visits) versus FFS (in clinic individual visits), and 3) between PCMH (in clinic group visits) versus DM (phone group visits). Adjusted for affiliation, sex, race/ethnicity, education, diabetes, cardiovascular disease, and travel time to clinic.

  Baseline and 6, 18 and 24 months

Secondary Outcomes (13)

• Mean Percent Weight Loss Over 24 Months; Unadjusted Except for Affiliation

  Baseline and 6, 18 and 24 months

• Mean Change in Systolic Blood Pressure; Unadjusted Except for Affiliation

  Baseline and 6, 18 and 24 months

• Mean Change in Diastolic Blood Pressure; Unadjusted Except for Affiliation

  Baseline and 6, 18 and 24 months

• Mean Change in Fasting Glucose; Unadjusted Except for Affiliation

  Baseline and 6 and 24 months

• Mean Change in Fasting Cholesterol; Unadjusted Except for Affiliation

  Baseline and 6 and 24 months

Study Arms (3)

Fee-for-Service Model (FFS, In clinic individual visits)

ACTIVE COMPARATOR

Participants will receive individual counseling from their physician or other healthcare professional during regular clinic visits.

Behavioral: Fee-for-Service Model (FFS, In clinic individual visits)

Patient Centered Medical Home (PCMH, In clinic group visits)

ACTIVE COMPARATOR

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.

Behavioral: Patient Centered Medical Home (PCMH, In clinic group visits)

Disease Management (DM, Phone group visits)

ACTIVE COMPARATOR

Participants will take part in group weight-management counseling by telephone.

Behavioral: Disease Management (DM, Phone group visits)

Interventions

Fee-for-Service Model (FFS, In clinic individual visits) BEHAVIORAL

To be performed by participant's doctor or other healthcare professional in their doctor's office.

Also known as: Individual weight management counseling

Fee-for-Service Model (FFS, In clinic individual visits)

Patient Centered Medical Home (PCMH, In clinic group visits) BEHAVIORAL

To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.

Also known as: Group weight management counseling (in-person and telephone)

Patient Centered Medical Home (PCMH, In clinic group visits)

Disease Management (DM, Phone group visits) BEHAVIORAL

To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.

Also known as: Group weight management counseling (telephone)

Disease Management (DM, Phone group visits)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (6)

• 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.

  PMID: 35398370 DERIVED

• 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.

  PMID: 35081912 DERIVED

• 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.

  PMID: 34714976 DERIVED

• 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.

  PMID: 34175347 DERIVED

• 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.

  PMID: 33496775 DERIVED

• 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.

  PMID: 32126987 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Diabetes Mellitus; Heart Diseases

Interventions

Disease Management

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration

Results Point of Contact

• Title: Christie Befort, PhD
• Organization: University of Kansas Medical Center

cbefort@kumc.edu

913 588-3338

Study Officials

• Christie Befort, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 28, 2015
• Study Start: February 15, 2016
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: December 7, 2020
• Results First Posted: July 29, 2020

Record last verified: 2020-12

Locations

US (1)