PROVE Trial: Weight Loss and Exercise for Peripheral Artery Disease

This study, called the PROVE Trial, is looking at whether combining a weight loss program with walking exercise can better improve or slow the decline in walking ability for people with peripheral artery disease (PAD) and a BMI (Body Mass Index) over 25 kg/m2. The weight loss program includes coaching, mobile technology, and a special diet. You could join if you are at least 18 years old, have PAD (diagnosed by specific ankle or toe blood pressure readings), and a BMI over 25. The main goal is to see how far participants can walk in six minutes after 12 months.

Study design
This is a randomized clinical trial with 212 participants. You would be assigned to either a group receiving weight loss support plus exercise, or a group receiving exercise alone.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 months to measure changes in their six-minute walk distance.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04228978

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

Recruiting
NAAges 18+InterventionalTreatment
Northwestern University
~212 participants
Updated 2026-05-07 on ClinicalTrials.gov
What's tested:Weight lossExercise

At a glance

Recruiting sites
6 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
12-month change in six-minute walk distance
Measured over Baseline to 12 months
Peripheral Artery Disease
Overweight or Obesity
7 sites across 6 states
Illinois2
Louisiana1
Maryland1
Michigan1
Minnesota1
Ohio1
  • Mary M McDermott, MD · PRINCIPAL_INVESTIGATOR · Northwestern University
  • Walter Ambrosius, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University

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  • 12-month change in six-minute walk distanceBaseline to 12 months

    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.