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

NCT04228978 | Recruiting DMC

• 2 other identifiers: STU00209524UG3HL141729-01A1
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Peripheral Artery Disease; Overweight or Obesity

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 months

Secondary Outcomes (5)

• 12-month change in minutes of walking exercise/week

  Baseline to 12 months

• 12-month change in physical activity measured by accelerometer data

  Baseline to 12 months

• 12-month change in Walking Impairment Questionnaire (WIQ) distance score

  Baseline to 12 months

• 12-month change in Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire

  Baseline to 12 months

• 6-month change in 6-minute walk distance

  Baseline to 6 months

Other Outcomes (9)

• 12-month change in perceived exertional effort at the end of the six-minute walk test

  Baseline to 12 months

• 12-month change in diet quality measured by change in Healthy Eating Index

  Baseline to 12 months

• Change in the short physical performance (SPPB) battery questionnaire at 12-month follow-up

  Baseline to 12 months

Study Arms (2)

Weight loss + exercise (WL+EX)

EXPERIMENTAL

Weight loss + home based walking exercise (WL+EX)

Behavioral: Weight loss; Behavioral: Exercise

Exercise alone (EX)

ACTIVE COMPARATOR

Home based walking exercise (EX)

Behavioral: Exercise

Interventions

Weight loss BEHAVIORAL

Walking exercise combined with weight loss

Weight loss + exercise (WL+EX)

Exercise BEHAVIORAL

Walking exercise

Exercise alone (EX); Weight loss + exercise (WL+EX)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Wake Forest University: collaborator

Study Sites (7)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Tulane University

New Orleans, Louisiana, 70130, United States

ACTIVE NOT RECRUITING

Johns Hopkins University

Baltimore, Maryland, 21287, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 37642035 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Overweight; Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mary M McDermott, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Walter Ambrosius, PhD

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary M McDermott, MD

CONTACT

312-503-6419; mdm608@northwestern.edu

Kathryn J Domanchuk, BS

CONTACT

312-503-6438; k-domanchuk@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors performing outcome measures will be unaware of participants' group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Jeremiah Stamler Professor

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: January 14, 2020
• Study Start: March 1, 2020
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)