RECRUITING

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

Conditions

Peripheral Artery Disease Overweight or Obesity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

PROmote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to preVEnt Mobility Loss: The PROVE Trial

Quick Facts

Study Start:2020-03-01

Study Completion:2027-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04228978

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	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.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

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.

Contacts and Locations

Study Contact

Mary M McDermott, MD

CONTACT

312-503-6419

mdm608@northwestern.edu

Kathryn J Domanchuk, BS

CONTACT

312-503-6438

k-domanchuk@northwestern.edu

Principal Investigator

Mary M McDermott, MD

PRINCIPAL_INVESTIGATOR

Northwestern University

Walter Ambrosius, PhD

PRINCIPAL_INVESTIGATOR

Wake Forest University

Study Locations (Sites)

Northwestern University

Chicago, Illinois, 60611

United States

Tulane University

New Orleans, Louisiana, 70130

United States

Johns Hopkins University

Baltimore, Maryland, 21287

United States

Henry Ford Health

Detroit, Michigan, 48202

United States

University of Minnesota

Minneapolis, Minnesota, 55455

United States

Collaborators and Investigators

Sponsor: Northwestern University

Mary M McDermott, MD, PRINCIPAL_INVESTIGATOR, Northwestern University
Walter Ambrosius, PhD, PRINCIPAL_INVESTIGATOR, Wake Forest University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-03-01

Study Completion Date2027-05-31

Study Record Updates

Study Start Date2020-03-01

Study Completion Date2027-05-31

Terms related to this study

Additional Relevant MeSH Terms

Peripheral Artery Disease
Overweight or Obesity