Actively Recruiting
Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss
Led by Northwestern University · Updated on 2026-05-07
212
Participants Needed
7
Research Sites
387 weeks
Total Duration
On this page
Sponsors
N
Northwestern University
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Presence of peripheral artery disease (PAD)
- Body mass index (BMI) greater than 25 kg/m2
- Age 18 years or older
- Diagnosis of PAD confirmed by ankle brachial index (ABI) ≤ 0.90, or toe brachial index ≤ 0.70, or ABI > 0.90 and ≤ 1.00 with ≥ 20% drop after heel-rise test, or vascular laboratory/angiographic evidence of PAD
- History of lower extremity revascularization with symptomatic PAD and ABI > 0.90 with ≥ 20% drop after exercise test
You will not qualify if you...
- Above or below knee amputation, critical limb ischemia, or wheelchair confinement
- Walking limited by a condition other than PAD
- Failure to complete study run-in by not entering at least 800 Kcal of consumed calories per day for 5 days during 14-day run-in
- Major surgery, coronary or leg revascularization in past 3 months or anticipated in next year
- Heart attack or stroke in past 3 months
- Major medical illness including lung disease requiring oxygen, life-threatening illness, Parkinson's disease, cancer requiring treatment in past 2 years (except early stage with excellent prognosis)
- Mini-Mental Status Examination score less than 23 unless explained by non-cognitive reasons
- Recent treatment for schizophrenia or psychosis in past 6 months
- Psychiatric hospitalization in past 6 months
- BMI greater than 45 kg/m2
- Active significant eating disorder within past 5 years or weight loss treatment in past 6 months
- Weight change over 25 pounds in past 6 months
- Unwilling or unable to use a smartphone or attend weekly study sessions
- Excessive alcohol use (>14 drinks/week men, >10 drinks/week women)
- Current foot ulcer
- Current or recent supervised treadmill exercise participation
- Increase in angina or angina at rest without clearance
- Non-English speaking
- Visual impairment limiting walking
- Regular walking exercise at level comparable to study
- Participation in clinical trial in past 3 months
- Investigator discretion if trial is unsafe or unsuitable
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
3
Tulane University
New Orleans, Louisiana, United States, 70130
Active, Not Recruiting
4
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Actively Recruiting
5
Henry Ford Health
Detroit, Michigan, United States, 48202
Actively Recruiting
6
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
7
Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
M
Mary M McDermott, MD
CONTACT
K
Kathryn J Domanchuk, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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