Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India

Table 2 Sample size estimates for the combined effect of pre- and peri-conception intervention package and enhanced antenatal, postnatal and early childhood care (A vs D)

	Main effect size	Sample size per group
Linear growth at 24 months
- Mean LAZ	0.20 SD (absolute value 0.80 cm at 24 mo)	527
- Proportion stunted (30%)	30% relative reduction	491
Birth weight/birth length	0.20 SD (absolute value 100 g birth weight and 0.45 cm birth length)	527
Proportion LBW (25%)	30% relative reduction	624
Preterm birth (12%) [35]	30% relative reduction	1100
SGA at birth (36%) [10]	30% relative reduction	381

90% power for all outcomes except 80% for preterm births. 95% confidence level for all outcomes

ISSN: 1745-6215