Table 2.
Summary of methodology and approach
| 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 | ||
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
aCHUS-RCT: Centre hospitalier universitaire de Sherbrooke-randomized controlled trial