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Table 2 Summary of methodology and approach

From: The Obesity-Fertility Protocol: a randomized controlled trial assessing clinical outcomes and costs of a transferable interdisciplinary lifestyle intervention, before and during pregnancy, in obese infertile women

Variables Sources Time of data collection
CHUS-RCT Comparison fertility clinics
1. Development and implementation of the interdisciplinary lifestyle intervention
 Health professionals’ perceptions and satisfaction toward obesity and fertility management Questionnaire At the end of the study Retrospectively
Focus groups
 Patients’ perceptions and satisfaction toward weight management and fertility care Questionnaire At 18 months or 24–28 weeks pregnant At the end of the study
Focus groups
2. Evaluation of lifestyle benefits and impact on fertility, pregnancy complications and neonatal outcomes
 Live-birth rate Review of patient medical record Throughout the study Retrospectively
 Lifestyle and anthropometric outcomesa   Baseline, 6 months, 12 months, and 18 months. Among women who become pregnant: beginning of the pregnancy and 24–28 weeks pregnant. N/A
  ∙ Anthropometric measures Standard calibrated scale and standing electric bioimpedance
  ∙ Vital signs Automatic blood pressure monitor
  ∙ Metabolic markers related to insulin secretion, androgen, lipid profile and OGTT Blood sample
  ∙Lifestyle habits (diet, exercise, sleep, alcohol, and tobacco) Questionnaire adapted from the one used by Statistics Canada for the latest Canadian Health Survey
  ∙ Physical fitness level Six-minute walk test
  ∙ Daily energy expenditure from physical activities, time spent in various physical activity intensities and step count Tri-axial accelerometer
  ∙ Readiness for change Questionnaire (WLRT [75])
  ∙ Quality of life Questionnaire (FertiQoL [76])
 Fertility outcomes   Throughout the study Retrospectively
  ∙ Pregnancy rate Positive β-hCG level in the serum
  ∙ Others Review of patient medical record
 Pregnancy adverse outcomes Review of patient medical record Throughout the study Retrospectively
 Neonatal outcomes Review of patient medical record Throughout the study Retrospectively
3. Evaluation of cost per live birth/cost-effectiveness of the interdisciplinary lifestyle intervention
 Costs of the interdisciplinary lifestyle interventiona Questionnaires Throughout the intervention N/A
Administrative data
 Costs of fertility treatments Review of patient medical record Throughout the study Retrospectively
Questionnaires
Administrative data
 Costs of adverse events or complications Review of patient medical record Throughout the study Retrospectively
Questionnaires
Administrative data
4. Knowledge transfer
 Scientific meeting presentations ASRM, CSEM, ENDO and other annual meetings Throughout the study
 Publication in scientific journals Human reproduction, Fertility and sterility, Journal of clinical endocrinology & metabolism, etc. Throughout the study
 Presentations to decision-makers and knowledge users Solicited and unsolicited invitations Throughout the study
 Diffusion to stakeholders Conduit, letters, e-mails Throughout the study
 Executive summary   At the end of the study
  1. ART Assisted reproductive technologies, β-hCG Beta-human chorionic gonadotropin, IVF In Vitro Fertilization, ASRM American society for reproductive medicine, CSEM Canadian society of endocrinology and metabolism, ENDO Endocrine society, FertiQoL Fertility quality of life tool, OGTT Oral glucose tolerance test, WLRT Weight loss readiness tool
  2. aCHUS-RCT: Centre hospitalier universitaire de Sherbrooke-randomized controlled trial