Ng 2018.

Study characteristics
Methods	Study design: parallel‐group randomised controlled trial Setting: multi‐centre/hospital Study duration: June 2016 to August 2019 Sample size calculation: yes, but not (yet) achieved: protocol says 440, abstract reported on 264: "in order to show a difference in the proportion of participants achieving a high composite lifestyle score from 30% in the control arm to 50% in the study arm after 24 weeks of the intervention, with 80% power at a P value of < 0.05, 93 patients will be required in each arm. We have assumed a randomisation rate of 50% and assuming a drop‐out rate of 15–20%, 220 patients will be randomized to each arm (440 patients to be recruited in total)"
Participants	Number of participants randomised: 264; 133 in control, 131 in intervention Baseline characteristics (mean ± SD): not specified (abstract data only) Baseline differences: no baseline differences in vegetable intake, fruit intake, or folic acid intake; no further details on other baseline characteristics Inclusion criteria: women with infertility or women suffering from recurrent miscarriages, actively trying to conceive, age 18 to 45 years, fluent in the use and understanding of English, having a smartphone capable of running the online application Exclusion criteria: "women who are on a specific diet for medical reasons, women with insulin diabetes, and those undergoing any other means of lifestyle coaching, for example, personal trainer or group lifestyle coaching" Phase of fertility treatment: not specified
Interventions	Control: routine care + unstructured minimal preconception lifestyle advice Description: standard preconception advice offered by the UK National Health Service Intervention: combination of weight, diet, vitamin or mineral supplement intake (folic acid), alcohol intake, physical activity, and smoking Description: a personalised smartphone lifestyle coaching programme "Smarter Pregnancy". Through baseline and follow‐up lifestyle questionnaires (at 6, 12, 18, and 24 weeks) sent out via email, tailored lifestyle advice is generated. Tailored coaching includes a maximum of 3 interventions per week comprising text and email messages containing tips, recommendations, vouchers, seasonal recipes, and additional questions addressing behaviour, pregnancy status, body mass index (BMI), or adequacy of the diet. Coaching is focused on study participants who report inadequate intake of vegetables and fruit, and absence of folic acid supplementation, and those with unfavourable alcohol and smoking habits. Results from the questionnaires are shown on a personal online page to track a participant’s progress Duration: 6 months Frequency: multiple sessions, 2‐ to 3‐week email contact; screening at baseline, at 6, 12,18, and 24 weeks Setting: individual Mode of delivery: mobile app + email
Outcomes	Reported behavioural changes in diet: vegetable intake in grams/d and fruit intake in pieces/d, measured at baseline and at 3 months with on online lifestyle questionnaire Reported behavioural changes in vitamin or mineral supplement intake: number of women with adequate use of folic acid supplement (400 mg/d) measured at baseline and at 3 months with an online lifestyle questionnaire
Identification	Sponsorship source: NIHR Southampton Biomedical Research Centre Protocol available/trial registration: ISRCTN89523555 (not prospectively registered) Country: United Kingdom
Notes	No paper on RCT available yet (abstract ESHRE 2019). Study author replied by email: "we are in the process of submitting the iPLAN trial results for publication. We will be in touch when this is published"
Risk of bias
Bias	Authors' judgement	Support for judgement
Sequence generation	Low risk	Quote: "participating women will be randomised in programme by the computer generation of a series of validation codes which is unique for each participant"
Allocation concealment	Low risk	Quote: "computer generation of a series of validation codes which is unique for each participant. After completion of the baseline questionnaires, women will be randomised to the intervention or the control group. The randomisation process will be concealed" Comment: central randomisation by third party.
Blinding of participants and personnel All outcomes	High risk	Quote: "although clinicians were blinded throughout, due to the nature of the study, it was not possible to blind women who were randomised" Comment: clinicians were blinded but not clear if personnel delivering the intervention (research nurses) were blinded. Participants were aware of assigned intervention. Deviations from the intended intervention could have occurred
Blinding of outcome assessors Objective outcomes	Unclear risk	Not applicable; no objective outcome measures in this study
Blinding of outcome assessors Patient reported outcome measures	High risk	Quote: "the women’s diet and lifestyle were self reported through questionnaires and it was not possible to eliminate reporting biases" Comment: outcome assessor is participant and is not blinded; reported behavioural changes are likely to be influenced. Eating more vegetables and fruit and adequate use of folic acid supplement are socially desirable
Incomplete outcome data	Unclear risk	Comment: only abstract with limited data is available as of February 2021, so risk of attrition bias is unclear at this point ITT analysis is planned. 400 women are recruited, 236 randomised (131 intervention, 133 control); no further information on missing data is available (yet)
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 are available as of February 2021, so risk of reporting bias is high at this point
Other sources of bias	High risk	Comment: only abstracts with interim analyses are available