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 |