NCT04589793 2020.

Study name	COLIFE
Methods	Study design: parallel‐group randomised controlled trial Setting: multi‐centre?/hospital (Finland)
Participants	780 couples with infertility and BMI between 27 kg/m² and 34.9 kg/m². Not specified if BMI counts for both partners
Interventions	Control: routine care Conventional infertility treatment Intervention: combination "4 sessions of video‐mediated motivational interview, anthropometric measurements, laboratory tests and epigenetic samples. Lifestyle intervention includes physical activity, diet, sleep and stress"
Outcomes	Live birth rate (primary outcome); any adverse event (pregnancy and delivery complications including gestational diabetes and hypertension); miscarriage rate; reported behavioural changes in combined score from 1 to 4 (smoking + daily vegetable and fruit use > 500 g + BMI 19 to 27 kg/m² + 150 minutes of moderate exercise/week = primary outcome); reported behavioural changes in weight (weight reduction in kg = primary outcome and BMI), diet (dietary content and pattern measured with FinTerveys dietary questionnaire), alcohol (alcohol consumption measured with FinTerveys dietary questionnaire), and physical activity (minutes per week measured with IPAQ); birth weight; quality of life (measured with FertiQOL)
Starting date	Estimated starting date: November 2020
Contact information	maritta.poyhonen‐alho@hus.fi
Notes	Status of study: ongoing: not yet recruiting. Estimated study completion date on clinicaltrials.gov is September 2025 Other notes: additional information on intervention would be valuable when study will be included. Awaiting reply from study authors