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Table 1 Inclusion and exclusion criteria

From: Feasibility outcomes of a presurgical randomized controlled trial exploring the impact of caloric restriction and increased physical activity versus a wait-list control on tumor characteristics and circulating biomarkers in men electing prostatectomy for prostate cancer

Inclusion criteria Exclusion criteria
• Adult men (age 19+) with pathologically confirmed prostate cancer who elected prostatectomy as their primary initial treatment.
• Scheduled for prostatectomy at one of the participating study sites.
• Potential lag-time between baseline (which had to be scheduled at least 2 weeks from prostatic biopsy) and follow-up appointments of at least 23 days a.
• Overweight or obese, but not class III morbidly obese (BMI range 25 to ≤50 kg/m2).
• Telephone access.
• Previous hormonal or neo-adjuvant chemotherapy.
• Another active malignancy (exception non-melanoma skin cancer) in addition to prostate cancer.
• Current health or medical condition that affects weight status, e.g., untreated hyper- or hypo-thyroidism, etc.
• Pre-existing medical condition that precludes adherence to unsupervised exercise, e.g., severe orthopedic conditions, scheduled for a hip or knee replacement, boney metastases, paralysis, dementia, untreated stage 3 hypertension, or unstable angina, heart attack, congestive heart failure or conditions that dictated hospitalization or oxygen within 6-months.
• Unable to read or speak English
• Unwillingness to be randomized to either the immediate weight loss intervention or the wait-listed control arms.
• Enrolled in a formal weight loss program.
  1. a This criteria was changed from that of the original study (i.e., 10 weeks), because potential recruits were unwilling to delay their surgery; therefore, we modified this criteria to correspond to that of our previous RCT in which we found significant effects with a 3-week dietary regimen. It should be noted despite this reduction in the criteria, the mean length of time that participants were on study was 7 weeks21,29