The PROVE Trial is a randomized clinical trial that will determine whether a weight loss intervention combined with walking exercise achieves greater improvement or less decline in six-minute walk distance at 12 month follow-up than walking exercise alone in people with PAD and BMI\>25 kg/m2. The intervention uses a Group Mediated Cognitive Behavioral framework, connective mobile technology, remote monitoring by a coach, and a calorie restricted Dietary Approaches to Stop Hypertension (DASH)-derived Optimal Macronutrient Intake Trial for Heart Health (OMNIHeart) diet. 212 participants with PAD and BMI \> 25 kg/m2 will be randomized to one of two groups: weight loss + exercise (WL+EX) vs. exercise alone (EX). Participants will be randomized at Northwestern, Tulane University, and University of Minnesota. Our primary outcome is change in six-minute walk distance at 12-month follow-up. Secondary outcomes are change in 6-minute walk distance at 6-month follow-up and change in exercise adherence, physical activity, patient-reported walking ability (measured by the Walking Impairment Questionnaire (WIQ) distance score), and mobility (measured by the Patient-Reported Outcomes Measurement Information System \[PROMIS\] mobility questionnaire) at 12-month follow-up. Tertiary outcomes are perceived exertional effort (measured by the Borg scale at the end of the 6-minute walk at 12-month follow-up), and diet quality. Exploratory outcomes consist of change in the short physical performance battery (SPPB), the WIQ stair climbing and walking speed scores, and calf muscle biopsy measures at 12-month follow-up. Study investigators will perform calf muscle biopsies in 50 participants to compare changes in mitochondrial biogenesis and activity, capillary density, and inflammation between WL+EX vs. EX.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
212
Walking exercise combined with weight loss
Walking exercise
Northwestern University
Chicago, Illinois, United States
RECRUITINGTulane University
New Orleans, Louisiana, United States
ACTIVE_NOT_RECRUITINGJohns Hopkins University
Baltimore, Maryland, United States
RECRUITINGHenry Ford Health
Detroit, Michigan, United States
RECRUITINGUniversity of Minnesota
Minneapolis, Minnesota, United States
RECRUITING12-month change in six-minute walk distance
Change in six-minute walk distance at 12-month follow-up will be compared between individuals randomized to weight loss + exercise vs. those randomized to exercise alone.
Time frame: Baseline to 12 months
12-month change in minutes of walking exercise/week
Change in minutes walked for exercise in a week will be compared between individuals randomized to the weight loss + exercise vs. those randomized to exercise alone at 12-month follow-up.
Time frame: Baseline to 12 months
12-month change in physical activity measured by accelerometer data
Change in physical activity at 12-month follow-up will be compared between individuals randomized to the weight loss + exercise vs. those randomized to exercise alone. Change in physical activity will be compared using accelerometer data.
Time frame: Baseline to 12 months
12-month change in Walking Impairment Questionnaire (WIQ) distance score
Change in Walking Impairment Questionnaire (WIQ) distance score at 12-month follow-up will be compared between individuals randomized to the weight loss + exercise vs. those randomized to exercise alone. The WIQ distance score ranges from 0-100 with a higher score indicating a better outcome.
Time frame: Baseline to 12 months
12-month change in Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire score at 12-month follow-up will be compared between individuals randomized to the weight loss + exercise vs. those randomized to exercise alone. A higher score is better. There is no set minimum and maximum values for the PROMIS questionnaire. However, a higher PROMIS score indicates a better outcome.
Time frame: Baseline to 12 months
6-month change in 6-minute walk distance
Change in six-minute walk distance at 6-month follow-up will be compared between individuals randomized to weight loss + exercise vs. those randomized to exercise alone.
Time frame: Baseline to 6 months
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