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New treatment option for Peripheral Artery Disease
Official title Promote Weight Loss in Obese Peripheral Artery Disease (PAD) Patients to Prevent Mobility Loss
ClinicalTrials.gov ID: NCT04228978
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- are a) presence of PAD; b) BMI\> 25 kg/m2; c) Age \>= 18. The diagnosis of PAD will be based on the following. First, an ankle brachial index (ABI)...
You likely can't join 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...
- 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...
See the full eligibility criteria
- are a) presence of PAD; b) BMI\> 25 kg/m2; c) Age \>= 18. The diagnosis of PAD will be based on the following. First, an ankle brachial index (ABI) value \ 0.90 and \ 0.90 who provide vascular laboratory evidence or...
- 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...
- 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...
- 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...
- 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
- 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
- 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...
- Non-English speaking
- Visual impairment that limits walking ability
- Currently walking regularly for exercise at a level comparable to the amount of exercise prescribed in the intervention
- 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...
- 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 study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- Minneapolis, Minnesota, United States
- Columbus, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States; New Orleans, Louisiana, United States; Baltimore, Maryland, United States; Detroit, Michigan, United States; Minneapolis, Minnesota, United States; Columbus, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.