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

Conditions

• Overweight or Obesity
• Peripheral Artery Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Weight loss — BEHAVIORAL
  Walking exercise combined with weight loss
• Exercise — BEHAVIORAL
  Walking exercise

Study Details

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.

Key Dates

Start date

Mar 1, 2020

Status verified

May 2026

Primary completion

Jun 30, 2027

Completion

Aug 1, 2027

Study Design

Enrollment

212 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Weight loss + exercise (WL+EX)
  Weight loss + home based walking exercise (WL+EX)
• Active Comparator: Exercise alone (EX)
  Home based walking exercise (EX)

Primary Outcome Measure

12-month change in six-minute walk distance [ Time Frame: Baseline to 12 months ]

Central Contacts

• Mary M McDermott, MD
  312-503-6419
  [email protected]
• Kathryn J Domanchuk, BS
  312-503-6438
  [email protected]

Locations (7)

Find similar trials in Chicago, IL

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