Belan 2019.

Study characteristics
Methods	Study design: parallel‐group randomised controlled trial Setting: single centre/hospital Study duration: start date: November 2011; estimated study completion date: September 2020 Sample size calculation: yes: "based on the outcome of live birth and the Fertility Fitness Programme, the inclusion of 58 women per group provides 80% power to identify a doubling in live‐birth rates with this programme (25% to 50%, α=5%). Assuming a dropout rate of 10% the final estimate sample size will be 128 women"
Participants	Number of participants randomised: 130 randomised (3 screen failures due to severe male factor infertility), 108 analysed at this point (57 in control, 51 in intervention) Baseline characteristics (mean ± SD): not specified (abstract data only) Baseline differences: no, study author replied by email: "there were no statistical or clinical differences between the intervention and control groups for the mPP analysis" Inclusion criteria: obese (BMI ≥ 30 kg/m²) or overweight if PCOS (BMI ≥ 27 kg/m²), women with infertility, age 18 to 40 years; infertility defined as (1) failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse in women who are under 35 years with regular menstrual cycles; (2) women who do not have regular menstrual cycles or are older than 35 years and have not conceived during a 6‐month trial period; or (3) women with a known cause of infertility Exclusion criteria: "bariatric surgery or plan for it and/or if natural conception is impossible or highly unlikely (tubal factor, severe male factor infertility, etc)" Phase of fertility treatment: intervention group pre‐treatment first 6 months, control group during treatment
Interventions	Control: routine care Description: standard fertility treatments, initiated as soon as clinically indicated. Standard fertility treatments may include lifestyle counselling by the obstetrician‐gynaecologist certified in gynaecological reproductive endocrinology and infertility (GREI), the reproductive endocrinologist, or the fertility specialist in charge of patient care Intervention: weight Description: individual counselling with a dietician and a kinesiologist (using S.M.A.R.T. goals and motivational interviewing) in combination with group sessions. Aim is to implement progressive and sustainable lifestyle changes to reach modest weight loss. Nutritional counselling with a dietician using 3‐day food diaries to evaluate women’s food intake throughout the programme, and Canada’s Food Guide and the “Healthy Plate” to help improve patients’ diet, The kinesiologist will be responsible for taking anthropometric measures and vital signs and for coaching women to increase their physical activity level. A pedometer will be offered to assist the patient + group sessions: 12 educational group sessions conducted by the dietician, the psychologist, or the kinesiologist (45‐minute interactive small group workshops and 45‐minute physical activity) covering various topics relevant to obesity management and fertility. These group sessions will take place weekly. When a pregnancy is confirmed, the woman will be met to set new objectives specific to her pregnancy, including optimal gestational weight gain based on Institute of Medicine guidelines. Partners will be invited to join individual meetings and will be strongly encouraged to attend all group sessions Duration: 18 months. First 6 months without additional fertility treatment, then 12 months in association with fertility treatment Frequency: multiple contacts, every 3 to 6 weeks, individual meetings with a dietician and a kinesiologist (20 to 30 minutes each). Follow‐up email or call in‐between meetings + 12 weekly educational group sessions (45‐minute interactive small group workshops and 45‐minute physical activity) Setting: individual + couple + group Mode of delivery: F2F + telephone + mail + group discussion + tools (food diary and online pedometer)
Outcomes	Live birth: percentage of live birth measured at 18 months Adverse events: gestational diabetes and preeclampsia (not further specified) Reported behavioural changes in weight: percentage of weight loss measured at 6 months Reported behavioural changes in diet: healthy eating score in points for measuring adherence to Canadian's Food Guide recommendations adapted from USA’s Healthy Eating Index (HEI). Measured at 6 months with questionnaire adapted from the Canadian Health Survey Reported behavioural changes in physical activity: total leisure activity energy expenditure in kcal/kg/d measured at 6 months with tri‐axial accelerometer Clinical pregnancy: study authors replied that they first used positive bhCG, following confirmation of a foetal heartbeat at ultrasound, or if the pregnancy exceeded 12 weeks (pregnancy from IVF + spontaneous pregnancy reported). Measured at 18 months Birth weight: not further specified Gestational age: not further specified
Identification	Sponsorship source: Canadian Institutes for Health Research (CIHR; FRN‐114125) and Ministère de la santé et des services sociaux of Québec (MSSS, Programme québécois de contrepartie au Programme departenariats pour l’amélioration du système de santé des IRSC) Protocol available/trial registration: NCT01483612 Country: Canada
Notes	No paper on RCT is available yet (abstract Endocrine Society 2019 + abstract ASRM 2019 with same data presented). Study author replied by email 07 July 2020, the following: "we are currently working on a paper, but it is not completed yet. Other than the information already published in the previous abstracts, we can't provide any new information at this point" Study authors contacted for more clarification on the numbers of participants randomised and analysed, definition and timing of assessing pregnancy, calculation of healthy score, and baseline differences. They replied: "current analyses are mainly according to our modified per protocol (mPP), in which we included the 108 women (57 control and 51 intervention) who have completed at least 6 months into the study or became pregnant during those 6 months" After update of the searches (January 2021), study authors were contacted for more information on adverse events, birth weight, and gestational age; awaiting reply as of February 2021
Risk of bias
Bias	Authors' judgement	Support for judgement
Sequence generation	Low risk	Quote: "an independent statistician will use computerised random number generation to allocate each participant to the intervention or control group. Randomisation will be stratified according to the PCOS or non‐PCOS status, based on clinical diagnosis in the patient’s record. Sequences will be generated using permuted block randomisation, with block sizes of two, four or six entries"
Allocation concealment	Low risk	Quote: "the allocation sequence will be concealed in corresponding sequentially numbered opaque envelopes. After a participant has completed baseline assessments, the research coordinator will open the envelope to reveal the group allocation to the participant. Participants will be informed of their group assignment at that time"
Blinding of participants and personnel All outcomes	High risk	Comment: participants and personnel were aware of assigned intervention; deviations from the intended intervention could have occurred
Blinding of outcome assessors Objective outcomes	Low risk	Comment: outcome assessors were not blinded. Live birth, weight, and clinical pregnancy were not likely to be influenced, as they are observer‐reported outcomes not involving judgement
Blinding of outcome assessors Patient reported outcome measures	High risk	Comment: outcome assessor is participant and is not blinded; reported behavioural changes are likely to be influenced. Eating healthy and moving is socially desirable
Incomplete outcome data	Unclear risk	Comment: only abstracts with limited data were available as of February 2021, so risk of attrition bias is unclear at this point 130 participants (65 intervention, 65 control) were randomised; 108 (83%) participants (51 intervention, 57 control) completed already 6 months of the trial and were analysed in modified per‐protocol analysis. For 97 (75%) participants (46 intervention and 51 control), follow‐up data regarding behavioural changes were available. Missing data were documented, but reasons were not (yet) reported
Selective outcome reporting	High risk	Comment: prospectively registered study protocol is available. Not all pre‐specified outcomes are reported at this point. Only abstracts with limited data were available as of February 2021, so risk of reporting bias is high at this point
Other sources of bias	Low risk	Comment: only abstracts with limited data are available