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Trial Status in_development on_going
Last Published February 24, 2022 01:54 PM October 28, 2022 10:37 AM
Experimental Design (Public) This is a parallel two-arm cluster-randomized controlled trial. A total of 1,420 caregiver-child dyads will be recruited and enrolled in the study. There are two participant inclusion criteria: 1) the child must be 9-14 months old at enrollment; and 2) the caregiver must be above 18 years old at enrollment. Study dyads will be randomly assigned at the level of dusun (a sub-village administrative unit in Indonesia) to one of two groups: 1) growth charts; and 2) pure control. Data will collected during a baseline survey administered at the time of enrollment and at an endline survey administered at the end of a 12-month intervention period. This is a parallel two-arm cluster-randomized controlled trial. A total of 1,480 caregiver-child dyads will be recruited and enrolled in the study. There are two participant inclusion criteria: 1) the child must be 9-14 months old at enrollment; and 2) the caregiver must be above 18 years old at enrollment. Study dyads will be randomly assigned at the level of dusun (a sub-village administrative unit in Indonesia) to one of two groups: 1) growth charts; and 2) pure control. Data will collected during a baseline survey administered at the time of enrollment and at an endline survey administered at the end of a 12-month intervention period.
Planned Number of Observations 1,420 caregiver-child dyads (5 per dusun) 1,480 caregiver-child dyads
Sample size (or number of clusters) by treatment arms 142 dusun (710 caregiver-child dyads) control, 142 dusun (710 caregiver-child dyads) treatment 142 dusun control, 142 dusun treatment
Power calculation: Minimum Detectable Effect Size for Main Outcomes The study is powered at 80 percent to detect a 0.19 SD improvement in HAZ over the 12-month intervention period, assuming α=0.05, a follow-up rate of 80 percent (attrition of 20 percent, or 1 of 5 enrollees per dusun), and an intra-class correlation coefficient (ICC) of 0.10. The study is powered at 80 percent to detect a 0.19 SD improvement in HAZ over the 12-month intervention period, assuming α=0.05, a follow-up rate of 80 percent (attrition of 20 percent), and an intra-class correlation coefficient (ICC) of 0.10.
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