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

Not Applicable

Recruiting

• Conditions: Peripheral Artery Disease; Overweight or Obesity
• Interventions: Behavioral: Weight loss; Behavioral: Exercise

• Registration Number: NCT04228978
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-14
• Study Start: 2020-03-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-22
• Last Update Posted: 2023-05-24
• Primary Completion: 2026-05-31
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 212

Inclusion Criteria

Not provided

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Exclusion Criteria

1. Above or below knee amputation, critical limb ischemia, or wheelchair confinement.

2. Walking is limited by a condition other than PAD.

3. 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*.

4. Major surgery, coronary or leg revascularization in the past 3 months or anticipated in the next year.

5. Experienced a heart attack or stroke in the past 3 months.

6. 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.

7. 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.

8. History of being treated for new onset or an acute episode of schizophrenia or psychosis in the past 6 months.

9. Hospitalization for a psychiatric disorder in the past 6 months.

10. BMI > 45 kg/m2

11. 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.

12. Weight gain or loss of more than 25 pounds in the past six months

13. Potential participants unwilling/unable to use a smart phone and unwilling to attend weekly study sessions.

14. Excessive alcohol use, defined as >14 drinks/week in men and > 10 alcoholic drinks/week in women.

15. Current ulcer on bottom of foot

16. Current participation in supervised treadmill exercise, participation in supervised treadmill exercise in the past three months, or planning to participate in supervised treadmill exercise in the next year

17. Increase in angina or angina at rest. Potential participants may become eligible following an abnormal baseline treadmill stress test if they have evidence of an absence of coronary ischemia based on testing with their own physician.

18. Non-English speaking

19. Visual impairment that limits walking ability

20. Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention

21. Participation in or completion of a clinical trial in the previous three months. [NOTE: after completing a stem cell or gene therapy intervention, participants will become eligible after the final study follow-up visit of the stem cell or gene therapy study so long as at least six months have passed since the final intervention administration. After completing a supplement or drug therapy (other than stem cell or gene therapy), participants will be eligible after the final study follow-up visit as long as at least three months have passed since the final intervention of the trial.]

22. In addition to the above criteria, investigator discretion will be used to determine if the trial is unsafe or not a good fit for the potential participant

    • The run-in will also be used to assist participants with learning the app. However, they must demonstrate ability to enter at least 800 Kcal per day for at least five days of the run-in.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Weight loss + exercise (WL+EX)	Weight loss	Weight loss + home based walking exercise (WL+EX)
Weight loss + exercise (WL+EX)	Exercise	Weight loss + home based walking exercise (WL+EX)
Exercise alone (EX)	Exercise	Home based walking exercise (EX)

Primary Outcome Measures

Name	Time	Method
12-month change in six-minute walk distance	Baseline to 12 months	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.

Secondary Outcome Measures

Name	Time	Method
12-month change in minutes of walking exercise/week	Baseline to 12 months	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.
12-month change in physical activity measured by accelerometer data	Baseline to 12 months	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.
12-month change in Walking Impairment Questionnaire (WIQ) distance score	Baseline to 12 months	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.
12-month change in Patient-Reported Outcomes Measurement Information System (PROMIS) mobility questionnaire	Baseline to 12 months	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.
6-month change in 6-minute walk distance	Baseline to 6 months	Change in six-minute walk distance at 6-month follow-up will be compared between individuals randomized to weight loss + exercise vs. those randomized to exercise alone.

Trial Locations

Locations (5)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Tulane University; 🇺🇸 New Orleans, Louisiana, United States

Henry Ford Health; 🇺🇸 Detroit, Michigan, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States