Peripheral Artery DiseasePROVENCT04228978
Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss
A study testing Weight loss and Exercise in people with Peripheral Artery Disease and Overweight or Obesity, run by Northwestern University at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease, Overweight or Obesity
- What is being tested?
- Weight loss and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Mar 2020to 1 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
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- 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.
- Weight gain or loss of more than 25 pounds in the past six months
- Potential participants unwilling/unable to use a smart phone and unwilling to attend weekly study sessions.
- Excessive alcohol use, defined as >14 drinks/week in men and > 10 alcoholic drinks/week in women.
- Current ulcer on bottom of foot
- Current participation in supervised treadmill exercise, participation in supervised treadmill exercise in the past three months, or planning to participate in supervised treadmill exercise in the next year
- Increase in angina or angina at rest. Potential participants may become eligible following an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing with their own physician.
- Non-English speaking
- Visual impairment that limits walking ability
- Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
- Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.]
- In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Johns Hopkins University
Baltimore, Maryland, 21287
Northwestern University
Chicago, Illinois, 60611
University of Chicago
Chicago, Illinois, 60637
Ohio State University
Columbus, Ohio, 43210
Henry Ford Health
Detroit, Michigan, 48202
University of Minnesota
Minneapolis, Minnesota, 55455
Tulane University
New Orleans, Louisiana, 70130
About this study
Official title: PROmote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to preVEnt Mobility Loss: The PROVE Trial
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
- Peripheral Artery Disease, Overweight or Obesity
- Being tested
- Weight loss, Exercise
- Medical subject headings
- Peripheral Arterial Disease, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight lossBehavioural
Walking exercise combined with weight loss
ExerciseBehavioural
Walking exercise
| Study group | Role | What they receive |
|---|---|---|
| Weight loss + exercise (WL+EX) | Experimental | Weight loss + home based walking exercise (WL+EX) Receives: Behavioral: Weight loss; Behavioral: Exercise |
| Exercise alone (EX) | Active comparator | Home based walking exercise (EX) Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-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.
Measured: Baseline to 12 months
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Mar 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Wake Forest University
- Responsible party
- Principal investigator, Mary McDermott, Northwestern University
- Investigators
- Mary M McDermott, MD, Principal investigator, Northwestern UniversityWalter Ambrosius, PhD, Principal investigator, Wake Forest University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228978
- Sponsor's protocol ID
- STU00209524
- Other IDs
- UG3HL141729-01A1
- Acronym
- PROVE
- Status last verified
- Sep 2026
- First submitted
- 8 Dec 2019
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whipple MO, Pfammatter AF, Spring B, Rejeski WJ, Treat-Jacobson D, Domanchuk KJ, Dressler EV, Ferrucci L, Gildea L, Guralnik JM, Harvin L, Leeuwenburgh C, Polonsky TS, Reynolds E, Stowe CL, Sufit R, Van Horn L, Walkup MP, Ambrosius WT, McDermott MM. Study Design, Rationale, and Methodology for Promote Weight Loss in Patients With Peripheral Artery Disease Who Also Have Obesity: The PROVE Trial. J Am Heart Assoc. 2023 Sep 5;12(17):e031182. doi: 10.1161/JAHA.123.031182. Epub 2023 Aug 29.
PubMed 37642035McDermott MM, Cetlin MD, Domanchuk KJ, Xu S, Whipple MO, Polonsky T, Criqui MH, Guralnik JM, Tian L, Zhao L, Ho KJ, Greenland P, Treat-Jacobson D. Community-based recruitment with ankle brachial index testing to identify peripheral artery disease participants for randomized clinical trials. Am Heart J. 2026 Oct;300:107450. doi: 10.1016/j.ahj.2026.107450. Epub 2026 Apr 24.
PubMed 42035974