Who is eligible for clinical trial NCT04228978?

Participants must meet protocol criteria for Peripheral Artery Disease. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT04228978 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-05

Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss (NCT04228978)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: Northwestern University

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (1 items) and avoid the listed exclusions (23 items).

Location: Northwestern University — Chicago, Illinois

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

are a) presence of PAD; b) BMI\> 25 kg/m2; c) Age \>= 18. The diagnosis of PAD will be based on the following. First, an ankle brachial index (ABI) value \<= 0.90, which is a well-accepted standard for diagnosing PAD. People with a toe brachial index of \<=0.70, performed at the study visit, will be eligible. Second, people with an ABI of \>0.90 and \<=1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test will also be included. Third, potential participants with an ABI \> 0.90 who provide vascular laboratory evidence or angiographic evidence of PAD will be included. Prior vascular laboratory evidence consists of objective evidence of PAD including toe brachial index (TBI) \< 0.70, Duplex measure showing 70% stenosis or greater, a post-exercise ABI drop in either leg of 20% or greater, or ABI values \<= 0.90. Angiographic evidence of PAD consists of a stenosis of 70% or greater in a lower extremity artery. Fourth, people with a history of lower extremity revascularization who do not meet the criterion above and have an ABI \> 0.90 with a 20% or higher drop in ABI after an exercise test will be eligible if they have symptomatic PAD. Symptomatic PAD will be defined as leg symptoms associated with exertion that resolved within 10 minutes of rest. The presence of symptomatic PAD will be determined based on the claudication questionnaire, the six-minute walk, or principal investigator interview/discussion with the potential participant. The post-exercise ABI drop will be measured by obtaining an ABI, having the participant exercise, and then immediately repeating the ABI. The exercise may consist of either the six-minute walk test or the heel-rise test. The heel-rise test consists of 50 heel rises at a rate of one per second. From the beginning of the trial until early 2023, we used the BMI inclusion criterion of \> 28 kg/m2 because overweight and obesity are defined as a BMI of 25 to 29 kg/m2 and \> 30 kg/m2, respectively, and because in our PAD cohorts, those with BMI \> 28 kg/m2 have significantly greater functional impairment and faster functional decline than those with BMI of 20-28 kg/m2. In order to increase the rate of recruitment, on 1/19/2022, investigators reduced the BMI inclusion criterion to \> 25 kg/ m2. People with BMI above 25 are overweight or obese and therefore are expected to benefit from the healthy lifestyle intervention.

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Above or below knee amputation, critical limb ischemia, or wheelchair confinement.
Walking is limited by a condition other than PAD.
Failure to complete the study run-in, defined as not entering at least 800 Kcal of consumed calories per day for at least five days during the 14-day run-in\*.
Major surgery, coronary or leg revascularization in the past 3 months or anticipated in the next year.
Experienced a heart attack or stroke in the past 3 months.
Major medical illness including lung disease requiring oxygen or life-threatening illness, Parkinson's disease, a life-threatening illness with life expectancy less than six months, or cancer requiring treatment in the previous two years. \[NOTE: potential participants may still qualify if they have had treatment for an early stage cancer in the past two years and the prognosis is excellent.
Mini-Mental Status Examination (MMSE) score \< 23, dementia and substance abuse. Potential participants with an MMSE score of less than 23 may be eligible if the principal investigator determines that their lower score is due to reasons other than poor cognition. Other potential reasons for lower scores include poor literacy or that English is not their first language.
History of being treated for new onset or an acute episode of schizophrenia or psychosis in the past 6 months.
Hospitalization for a psychiatric disorder in the past 6 months.
BMI \> 45 kg/m2
History of a significant eating disorder that has been active within the past 5 years or any weight loss treatment in the past 6 months. Weight loss treatment includes weight watchers, any history of weight loss surgery, and using weight loss medications now or in the past six months.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (7 Sites)

Northwestern University — Chicago, Illinois
University of Chicago — Chicago, Illinois
Tulane University — New Orleans, Louisiana
Johns Hopkins University — Baltimore, Maryland
Henry Ford Health — Detroit, Michigan
University of Minnesota — Minneapolis, Minnesota
Ohio State University — Columbus, Ohio

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗