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Table 1 Participant eligibility criteria and assessment methods in the BETA Trial, Alberta, Canada

From: Study design and methods for the Breast Cancer and Exercise Trial in Alberta (BETA)

Reason for criterion Assessment methods Timing of assessment
Appropriate target group for breast cancer risk reduction
Female Screen Test 1 database Before contacting participant/immediately upon contact
Age 50–74 years at baseline Screen Test database or PEQ2 Before contacting participant
Postmenopausal PEQ After participant indicates interest
No previous breast cancer diagnosis PEQ After participant indicates interest
Fit to undertake exercise program
No major co-morbidities Screening questionnaires and blood tests After participant indicates interest
No previous invasive cancer PEQ After participant indicates interest
Passes the self-completed Physical Activity Readiness Questionnaire PEQ After participant indicates interest
Obtains physician approval to participate PARmed-X3; approval to do 60 minutes of aerobic exercise (“unrestricted physical activity – start slowly and build up gradually”) five times/week for 12 months After Information Session
Acceptably healthy heart and lung function during fitness test Sub-maximal treadmill test After blood sample and obtaining physician approval
Risk profile amenable to change with exercise intervention
Body mass index 22.0-40.0 PEQ (screening) and objective measurement of height and weight After participant indicates interest (PEQ) and after exercise tester approval (height and weight)
Moderately sedentary lifestyle (no more than 3 days/week of moderate-intensity recreational activity lasting a maximum of <30 minutes/session). Or, no more than 120 minutes of moderate-intensity recreational activity/week. PEQ (screening) and PYTPAQ4 (comprehensive) After participant indicates interest (PEQ) and at Information Session (PYTPAQ)
Estimated VO2max ≤ 34.5 mL/kg/min. If VO2max was between 34.6 and 37.0 mL/kg/min, accelerometer count <10,000 steps/day over seven days. Sub-maximal treadmill test; seven-day accelerometry (Actigraph GT3Xplus®) if VO2max 34.6-37.0 mL/kg/min After physician approval
No other outside factors to influence estrogen metabolism
Not currently, previously (<6 months) or planning to take drugs related to estrogen metabolism or breast tissue growth PEQ After participant indicates interest
Not a current smoker, or excessive drinker PEQ After participant indicates interest
Smoker = needs to have quit for at least 6 months
Drinking maximum = no more than 14 drinks/week
Not currently or planning to undertake a weight control/loss program or taking weight loss medications PEQ After participant indicates interest
Logistics   
Lives in Calgary or Edmonton Screen Test database and PEQ Before contacting participant and after participant indicates interest
English-speaking Initial contact with participant and PEQ After participant indicates interest (telephone recruiters will ascertain)
Not planning to be out of Calgary/Edmonton area more than 4 consecutive weeks during the subsequent 18 months or more than 8 weeks during the entire year. PEQ After participant indicates interest
  1. 1Screen Test: The Alberta Breast Screening Program.
  2. 2PEQ: Participant Eligibility Questionnaire.
  3. 3PAR-medX: Physical Activity Readiness Medical Examination.
  4. 4PYTPAQ: Past Year Total Physical Activity Questionnaire [51].