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NCT04228978 · ClinicalTrials.gov registry record · NA
Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss
A NA study of Peripheral Artery Disease and Overweight or Obesity, sponsored by Northwestern University.
- Recruiting
- Registry status
- NA
- Development phase
- 212
- Enrollment target
- 5
- Study locations
NCT04228978: Recruiting NA study of Peripheral Artery Disease and Overweight or Obesity, sponsored by Northwestern University.
NCT04228978 is a NA study of Peripheral Artery Disease and Overweight or Obesity that is actively recruiting participants, run by Northwestern University. The registered enrollment target is 212 participants, above the 122-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (74% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04228978, a NA study of Peripheral Artery Disease and Overweight or Obesity, is actively recruiting participants, sponsored by Northwestern University.
- RECRUITING
- Registry status
- NA
- Development phase
- 212 participants
- Enrollment target
- 5
- Study locations
Study 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. 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.
Primary Outcome
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.
Conditions Studied
Interventions
- BEHAVIORAL Exercise
- BEHAVIORAL Weight loss
Study Locations (5)
Illinois
- Northwestern University - Chicago
Louisiana
- Tulane University - New Orleans
Maryland
- Johns Hopkins University - Baltimore
Michigan
- Henry Ford Health - Detroit
Minnesota
- University of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2020-03-01 |
| Est. Completion | 2027-05-31 |
| Phase | NA |
What NCT04228978 shows while recruiting
NCT04228978 is an interventional study that assigns participants to a tested intervention. The registered 212 participants enrollment target is mid-sized for trials with a published cap, above the 122-participant average among 50 other Peripheral Artery Disease trials with a reported enrollment target (74% higher).
The record links to 2 conditions, with Peripheral Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which Exercise is the first listed.
NCT04228978 lists 5 locations in 5 states (Illinois, Louisiana, Maryland).
Frequently Asked Questions
What is clinical trial NCT04228978 about?
NCT04228978 is a clinical study titled "Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss". 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 in...
What is the current status of trial NCT04228978?
This trial is currently recruiting. It is a NA study. The enrollment target is 212 participants. The study started on 2020-03-01. Estimated completion is 2027-05-31.
What conditions does trial NCT04228978 study?
This clinical trial studies the following conditions: Peripheral Artery Disease, Overweight or Obesity.
What interventions are being tested in trial NCT04228978?
The interventions under investigation include: Exercise (BEHAVIORAL), Weight loss (BEHAVIORAL).
Who is sponsoring clinical trial NCT04228978?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04228978 being conducted?
This trial has 5 study locations across Illinois, Louisiana, Maryland, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04228978's enrollment target sits among peer trials
212 11th of 50 higher than 40 of 50 other Peripheral Artery Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Artery Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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