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

ConditionsPeripheral Artery Disease Overweight or Obesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNorthwestern University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Weight loss
Behavioral
Walking exercise combined with weight loss
Exercise
Behavioral
Walking exercise

Treatment groups

212 Participants

are divided into 2 treatment groups

Group A: Weight loss + exercise (WL+EX)Experimental treatment 2 interventions

Group B: Exercise alone (EX)Active comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to 12 months

Secondary outcomes

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.

Time frame

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.

Time frame

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.

Time frame

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.

Time frame

Baseline to 12 months

Other outcomes

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

Change in perceived exertional effort at the end of the six-minute walk test at 12-month follow-up will be compared between individuals randomized to the weight loss + exercise vs. those randomized to exercise alone. Perceived exertional effort will be measured using the Borg scale. The Borg scale is a 15-point scale ranging from six to 20. A higher score indicates greater perceived exertion.

Time frame

Baseline to 12 months

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

Change in diet quality measured by change in Healthy Eating Index (HEI) will be compared between individuals randomized to weight loss + exercise vs. those randomized to exercise alone. Change in diet quality will be measured at 12-month follow-up. The maximum HEI score is 100 points. A higher total HEI score indicates a diet that aligns better with dietary recommendations.

Time frame

Baseline to 12 months

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

Change in the short physical performance (SPPB) battery questionnaire will be compared between individuals randomized to weight loss + exercise vs. those randomized to exercise alone. The SPPB questionnaire ranges from 0 to 12 (12 = best).

Time frame

Baseline to 12 months

Change in the WIQ walking speed score at 12-month follow-up

Change in the WIQ walking speed score at 12-month follow-up will be compared between individuals randomized to weight loss + exercise vs. those randomized to exercise alone. The WIQ walking speed score ranges from 0-100. A higher score is better.

Time frame

Baseline to 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Wake Forest University

Collaborator

Source ClinicalTrials.gov

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