Table 2.
Inclusion criteria | Rationale |
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Accepted criteria for PAD in clinical practice guidelines. 3 |
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Overweight and obesity are defined as a BMI of 25–29 kg/m2 and >30 kg/m2. Observational evidence demonstrated a linear trend in association of normal BMI, overweight, and obesity with the magnitude of annual decline in 6‐minute walk distance among people with PAD. 4 |
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PAD is rare in children |
Exclusion criteria | Rationale |
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These criteria characterize severe or end stage PAD. Most individuals with PAD do not have severe/end stage PAD. |
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The WL+EX intervention is designed to improve walking impairment caused by PAD. |
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These individuals may not adhere to study requirements. |
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These procedures may influence functional performance, independent of study interventions. |
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These conditions may interfere with the ability to fully participate in and complete the study. |
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May interfere with ability to fully adhere to the study intervention or accurately complete questionnaires. |
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These individuals have morbid obesity that requires more intensive treatment than our intervention provides. |
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The WL+EX intervention is not intended for individuals with an eating disorder. Patients with recent weight loss may have weight change independently of the study interventions. |
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These individuals will not be able to fully engage in the intervention. |
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These individuals may not be able to lose weight. |
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These programs may influence functional performance, independent of study interventions. |
ABI indicates ankle brachial index; BMI, body mass index; PAD, peripheral artery disease; TBI, toe brachial index; and WL+EX, weight loss plus exercise.
Symptomatic PAD will be defined as leg symptoms associated with exertion that resolved within 10 minutes of rest. The presence of symptomatic PAD will be determined based on the claudication questionnaire, the 6‐minute walk, or principal investigator interview/discussion with the potential participant.
The run‐in period can be extended to assist participants with learning the app, but participants must demonstrate ability to enter at least 800 kcal per day for at least 5 days of the run‐in period.
Potential participants may still qualify if they have had treatment for an early‐stage cancer in the past 2 years and the prognosis is excellent.
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 6 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 provided at least 3 months have passed since the final intervention of the trial.