Mediterranean diet, Mindfulness-Based Stress Reduction and usual care during pregnancy for reducing fetal growth restriction and adverse perinatal outcomes: IMPACT BCN (Improving Mothers for a better PrenAtal Care Trial BarCeloNa): a study protocol for a randomized controlled trial

Table 1 Study timeline

	Enrolment	Allocation	Post-allocation								Close-up
*Time point*	*Pregnancy*	*Pregnancy*	*Pregnancy*				*Delivery*	*Postpartum*			*Postpartum*
	19–23.6 weeks	19–23.6 weeks	21–24.6 weeks	24–36 weeks	34–36.6 weeks	36–38 weeks		1–3 months	12 months	24 months	24 months
	Screening visit	Randomization visit	Initial visit	Interventions	Final visit	Extra visit		Postnatal follow-up
Enrollment:
Eligibility screen	√
Informed consent		√
Allocation		√
Interventions:
MD				√
MBSR program				√
Usual care				√
Assessments:
Baseline variables
Sociodemographic data			√
Medical history			√		√
Maternal life-style assessment			√		√			√		√
Maternal nutritional assessment			√		√
Outcome variables
Primary outcome							√
Perinatal outcomes							√	√
Infant Bayley-III										√	√
Infant cardiovascular assessment										√	√
Other variables
Biological samples:
Maternal biological samples			√		√			√		√
Feto-placental biological samples							√
Infant biological samples								√		√
Maternal and fetal imaging:
Feto-placental US assessment					√
EFW and feto-placental Doppler					√
Fetal echocardiography					√
Fetal neurosonography					√
Maternal and fetal magnetic resonance rimaging						√
Infant extra tests:
Infant NBAS								√
Infant ASQ									√

MedDiet Mediterranean diet, MBSR mindfulness-based stress reduction, US ultrasound, EFW estimated fetal weight, NBAS Neonatal Behavioral Assessment Scale, ASQ Ages and Stages Questionnaires

ISSN: 1745-6215