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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