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Exercise and Weight Loss for Obese PAD Patients (PROVE Trial)

N/A
Recruiting
Led By Mary M McDermott, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of PAD based on ABI of > 0.90 and <= 1.00 with a 20% or greater drop in ABI after the heel-rise test
History of lower extremity revascularization with symptomatic PAD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 12 months
Awards & highlights

PROVE Trial Summary

This trial will test whether a weight loss intervention combined with walking exercise is more effective than walking exercise alone in people with PAD and BMI > 28 kg/m2. The primary outcome is change in six-minute walk distance at 12-month follow-up.

Who is the study for?
This trial is for adults over 18 with Peripheral Artery Disease (PAD) and a Body Mass Index (BMI) of more than 25 kg/m2. They should have leg symptoms from PAD that improve with rest, and an ankle brachial index (ABI) below 0.90 or other diagnostic criteria for PAD. People can't join if they've had recent major surgery, are unable to use a smartphone, drink excessively, have certain medical conditions like severe lung disease or cancer under treatment, or if their walking is limited by something other than PAD.Check my eligibility
What is being tested?
The PROVE Trial tests whether combining weight loss strategies with walking exercises helps people with obesity and PAD walk better after one year compared to just exercise alone. The weight loss program includes group support, mobile tech monitoring by a coach, and a special low-calorie diet called the OMNIHeart diet.See study design
What are the potential side effects?
Potential side effects may include typical exercise-related issues such as muscle soreness or strain. Diet changes might cause digestive discomfort initially as the body adjusts to new eating habits.

PROVE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have PAD, confirmed by specific leg blood flow tests showing changes after exercise.
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I had surgery to improve blood flow in my legs due to PAD symptoms.
Select...
I am 18 years old or older.
Select...
I have been diagnosed with peripheral artery disease (PAD) based on tests or imaging.
Select...
I have been diagnosed with PAD based on specific index values.
Select...
I have peripheral artery disease (PAD).
Select...
I experience leg pain during exercise that stops after resting for 10 minutes.
Select...
You have peripheral artery disease (PAD), a body mass index (BMI) greater than 28 kg/m2, and are between the ages of 18 and 90. The diagnosis of PAD will be based on specific tests to measure blood flow in your legs, and if you have certain symptoms related to leg pain during physical activity.
Select...
I have peripheral artery disease (PAD).

PROVE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
12-month change in six-minute walk distance
Secondary outcome measures
12-month change in Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire
12-month change in Walking Impairment Questionnaire (WIQ) distance score
12-month change in minutes of walking exercise/week
+2 more
Other outcome measures
12-month change in calf muscle biopsy measured COX enzyme activity
12-month change in calf muscle inflammation (IL-6, TNF-α, and IL1β)
12-month change in capillary density (capillaries per muscle fiber)
+6 more

Side effects data

From 2016 Phase 3 trial • 150 Patients • NCT00856609
98%
hunger decrease
60%
Nausea
57%
Headache
40%
Diarrhea
35%
Constipation
33%
Injection site reaction
33%
Gastroesophageal reflux
30%
Itchiness
28%
Vomiting
25%
hypoglycemia
15%
Skin rash
10%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Exenatide
Placebo

PROVE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Weight loss + exercise (WL+EX)Experimental Treatment2 Interventions
Weight loss + home based walking exercise (WL+EX)
Group II: Exercise alone (EX)Active Control1 Intervention
Home based walking exercise (EX)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Exercise
2016
Completed Phase 1
~760
Weight loss
2010
Completed Phase 4
~1690

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,579 Previous Clinical Trials
916,573 Total Patients Enrolled
32 Trials studying Obesity
11,032 Patients Enrolled for Obesity
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,819 Previous Clinical Trials
47,295,545 Total Patients Enrolled
250 Trials studying Obesity
205,696 Patients Enrolled for Obesity
Wake Forest UniversityOTHER
187 Previous Clinical Trials
153,325 Total Patients Enrolled
6 Trials studying Obesity
809 Patients Enrolled for Obesity

Media Library

Exercise Clinical Trial Eligibility Overview. Trial Name: NCT04228978 — N/A
Obesity Research Study Groups: Weight loss + exercise (WL+EX), Exercise alone (EX)
Obesity Clinical Trial 2023: Exercise Highlights & Side Effects. Trial Name: NCT04228978 — N/A
Exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT04228978 — N/A
Obesity Patient Testimony for trial: Trial Name: NCT04228978 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the criteria to qualify for participating in this trial?

"This trial is recruiting 212 people suffering from peripheral arterial disease (PAD) aged between 18 and 89. To be eligible, candidates must meet the following criteria: a BMI of more than 28 kg/m2; an ankle-brachial index below 0.90 or a toe brachial index below 0.70 after heel rise test with 20% drop in ABI; prior vascular laboratory evidence such as objective indications of PAD including TBI at <0.7, Duplex measure showing 70% stenosis or higher, post heel-rise ABI decrease of 20%; angiographic proof of PAD consisting a"

Answered by AI

Are there opportunities for participants to join this trial?

"Affirmative. The information posted on clinicaltrials.gov reveals that this medical trial, which was first announced on March 1st 2020, is still actively recruiting participants. To date 212 patients have been sought from a single site."

Answered by AI

Is the minimum age for enrolment in this trial set at 25 or higher?

"According to the specified rules, only individuals aged 18 to 89 may join this trial. There are 80 opportunities for minors and 550 openings for seniors above 65 years old."

Answered by AI

What is the total number of participants in this experiment?

"Yes, according to the information on clinicaltrials.gov this trial is actively recruiting patients. It was initially posted on March 1st 2020 and last updated February 17th 2022, with a total of 212 participants needed from one site."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Illinois
How old are they?
18 - 65
What site did they apply to?
University of Minnesota
Northwestern University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

I need to lose weight. I want to keep my A1c in the normal range.
PatientReceived no prior treatments
~74 spots leftby May 2026