Because this study was part of a 2-year, 3-group RCT, the sample size was based only on the outcome at 24 months of child age (ie, body mass index z score). In the published study protocol, a sample size of 1056 was required at baseline. This size was based on detecting a difference in the mean body mass index z score of 0.29 units between each intervention group and the control group at 2 years of age with 80% power and a 5% level of significance, allowing for a 25% loss to follow-up.
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