治験レーダー

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 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.

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.

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 surgery, and using weight loss medications now or in the past six months.

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 own physician.

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 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.]

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.