TY - JOUR
T1 - Study Design, Rationale, and Methodology for Promote Weight Loss in Patients With Peripheral Artery Disease Who Also Have Obesity
T2 - The PROVE Trial
AU - Whipple, Mary O.
AU - Pfammatter, Angela Fidler
AU - Spring, Bonnie
AU - Rejeski, W. Jack
AU - Treat-Jacobson, Diane
AU - Domanchuk, Kathryn J.
AU - Dressler, Emily V.
AU - Ferrucci, Luigi
AU - Gildea, Lois
AU - Guralnik, Jack M.
AU - Harvin, Lea
AU - Leeuwenburgh, Christiaan
AU - Polonsky, Tamar S.
AU - Reynolds, Eric
AU - Stowe, Cynthia L.
AU - Sufit, Robert
AU - Van Horn, Linda
AU - Walkup, Michael P.
AU - Ambrosius, Walter T.
AU - McDermott, Mary M.
N1 - Publisher Copyright:
© 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
PY - 2023/9/5
Y1 - 2023/9/5
N2 - 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/m2 will be randomized. Interventions are delivered using a Group Mediated Cognitive Behavioral intervention model, a smartphone application, and individual telephone coach-ing. 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.
AB - 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/m2 will be randomized. Interventions are delivered using a Group Mediated Cognitive Behavioral intervention model, a smartphone application, and individual telephone coach-ing. 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.
KW - eating behavior
KW - home-based exercise
KW - mitochondria
KW - obesity
KW - peripheral artery disease
KW - physical function
KW - randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85169847601&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85169847601&partnerID=8YFLogxK
U2 - 10.1161/JAHA.123.031182
DO - 10.1161/JAHA.123.031182
M3 - Article
C2 - 37642035
AN - SCOPUS:85169847601
SN - 2047-9980
VL - 12
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 17
M1 - e031182
ER -