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. Author manuscript; available in PMC: 2018 Feb 1.
Published in final edited form as: Contemp Clin Trials. 2016 Dec 24;53:151–161. doi: 10.1016/j.cct.2016.12.021

Table 1.

Inclusion and exclusion criteria (self-reported, unless otherwise indicated)

Inclusion
    ■ Age: ≥18 years of age
        - Women: Pre-menopausal (self-report) and ≤50 years of age
        - Men: ≤50 years of age
    ■ Race/Ethnicity: All
    ■ BMI (body mass index): 28-40 kg/m2 (Measured in clinic)
    ■ Body weight stable for the last two months, and not actively on a weight loss plan
    ■ No plans to move from the area over the next 12 months from start of study cohort
    ■ Available and able to participate in the evaluations and intervention for the study period
    ■ Willing to accept random assignment
    ■ To enhance study generalizability, people on medications not noted below as specific exclusions can participate if they have been stable on such medications for at least three months
    ■ Ability and willingness to give written informed consent
    ■ No known active psychiatric illness
Exclusion
    ■ Pregnant, lactating, within 6 months post-partum, or planning to become pregnant in the next year
    ■ Diabetes (type 1 and 2) or history of gestational diabetes or on hypoglycemic medications for any other indication
    ■ Prevalent diseases: Malabsorption, renal or liver disease, active neoplasms, recent myocardial infarction (<6 months)
    ■ Currently smoking
    ■ History of serious arrhythmias, or cerebrovascular disease
    ■ History of Bariatric Surgery
    ■ Uncontrolled hyper- or hypothyroidism (TSH not within normal limits, self-report)
    ■ Medications: Lipid lowering, antihypertensive medications, and those known to affect weight/energy expenditure
    ■ Excessive alcohol intake (self-reported, ≥ to 2 drinks/day for men or ≥1 drink/day for women)
    ■ Musculoskeletal disorders precluding regular physical activity
    ■ Unable to follow either of the two study diets for reasons of food restrictions (e.g., vegan)
    ■ Currently under psychiatric care, or taking psychiatric medications
    ■ Inability to communicate effectively with study personnel