Bivia‐Roig 2020.

Study name	HLRP‐RCT
Methods	Study design: parallel‐group randomised controlled trial Setting: single centre/hospital (Spain)
Participants	94 women with diagnosed primary infertility and BMI between 25 kg/m² and 40 kg/m²
Interventions	Control: routine care and unstructured minimal preconception lifestyle advice Standard treatment, which consists of regular gynaecological visits. The Reproduction Service gynaecologists will recommend healthy lifestyle habits and will give patients a document detailing a specific diet they should follow for weight loss Intervention: weight (weight, diet, and physical activity) "A 3‐month internet‐based program focusing on the promotion of healthy lifestyles. The treatment protocol comprises 9 modules which incorporate psychological strategies to promote healthy lifestyles by gradually changing eating and physical activity habits"
Outcomes	Ongoing pregnancy ("pregnancy with ultrasound visualisation of the gestational sac and heartbeat after 20 weeks of gestation" = primary outcome); reported behavioural changes in weight (BMI), diet (Mediterranean diet adherence measured with MEDAS), physical activity (measured with IPAQ). Additional outcomes specified in protocol paper: diet (measured with FFQ) and quality of life (measured with FertiQOL)
Starting date	February 2020
Contact information	gemma.bivia@uchceu.es (PhD); juanfran@uchceu.es (PI)
Notes	Status of study: ongoing: recruiting. Estimated study completion date on clinicaltrials.gov is December 2021 Other notes: additional outcomes described in the protocol but not on clinicaltrials.gov, including diet and quality of life