Study Design, Rationale, and Methodology for Promote Weight Loss in Patients With Peripheral Artery Disease Who Also Have Obesity: The PROVE Trial

Author:

Whipple Mary O.1ORCID,Pfammatter Angela Fidler2ORCID,Spring Bonnie3ORCID,Rejeski W. Jack4ORCID,Treat‐Jacobson Diane1ORCID,Domanchuk Kathryn J.3,Dressler Emily V.5ORCID,Ferrucci Luigi6ORCID,Gildea Lois1,Guralnik Jack M.7,Harvin Lea5,Leeuwenburgh Christiaan8ORCID,Polonsky Tamar S.9ORCID,Reynolds Eric5,Stowe Cynthia L.5ORCID,Sufit Robert3ORCID,Van Horn Linda3ORCID,Walkup Michael P.4,Ambrosius Walter T.5,McDermott Mary M.3ORCID

Affiliation:

1. School of Nursing University of Minnesota Minneapolis MN

2. College of Education, Health, and Human Sciences University of Tennessee Knoxville TN

3. Feinberg School of Medicine Northwestern University Chicago IL

4. Department of Health and Exercise Science Wake Forest University Winston‐Salem NC

5. Department of Biostatistics and Data Science Wake Forest University School of Medicine Winston‐Salem NC

6. National Institute on Aging, National Institutes of Health Baltimore MD

7. University of Maryland School of Medicine Baltimore MD

8. College of Medicine University of Florida Gainesville FL

9. University of Chicago Medicine Chicago IL

Abstract

Background Overweight and obesity are associated with adverse functional outcomes in people with peripheral artery disease (PAD). The effects of weight loss in people with overweight/obesity and PAD are unknown. Methods The PROVE (Promote Weight Loss in Obese PAD Patients to Prevent Mobility Loss) Trial is a multicentered randomized clinical trial with the primary aim of testing whether a behavioral intervention designed to help participants with PAD lose weight and walk for exercise improves 6‐minute walk distance at 12‐month follow‐up, compared with walking exercise alone. A total of 212 participants with PAD and body mass index ≥25 kg/m 2 will be randomized. Interventions are delivered using a Group Mediated Cognitive Behavioral intervention model, a smartphone application, and individual telephone coaching. The primary outcome is 12‐month change in 6‐minute walk distance. Secondary outcomes include total minutes of walking exercise/wk at 12‐month follow‐up and 12‐month change in accelerometer‐measured physical activity, the Walking Impairment Questionnaire distance score, and the Patient‐Reported Outcomes Measurement Information System mobility questionnaire. Tertiary outcomes include 12‐month changes in perceived exertional effort at the end of the 6‐minute walk, diet quality, and the Short Physical Performance Battery. Exploratory outcomes include changes in gastrocnemius muscle biopsy measures of mitochondrial cytochrome C oxidase activity, mitochondrial biogenesis, capillary density, and inflammatory markers. Conclusions The PROVE randomized clinical trial will evaluate the effects of exercise with an intervention of coaching and a smartphone application designed to achieve weight loss, compared with exercise alone, on walking performance in people with PAD and overweight/obesity. Results will inform optimal treatment for the growing number of patients with PAD who have overweight/obesity. Registration URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04228978.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Cardiology and Cardiovascular Medicine

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