Mobile Health Solutions to Help Community Providers Promote Maternal & Infant Nutrition & Health - A Community-based Cluster RCT in Rural India to Evaluate M-SAKHI for Use by ASHAs to Reduce Malnutrition in Infants up to 24 Months

a. Study design: Using a community-based, cluster randomized controlled trial design (cRCT) the investigators will examine the impact of an integrated "m-health package - (M- SAKHI) for mothers on appropriate infant feeding practices, starting in the first / second trimester of pregnancy to one year after delivery, to improve child feeding practices and child growth, and reduce the prevalence of undernutrition in their children. This will result in two treatment groups (see diagram). The clusters for the trial will be villages under the administrative area of ASHAs. Villages with a population of 1000- 2000 (ranging from 751 to 2000) with single ASHA will be randomized to receive either this intervention (intervention villages) or continue with existing delivery of care (control villages). Selecting a single village per ASHA criteria will reduce the chances of contamination of study groups. The data will be collected using a longitudinal design because the investigators want to study the impact of intervention on the mothers starting at pregnancy until her infant is 24 month old. This is preferred to a cross sectional design to reduce the impact due to migration of mothers in or out of the clusters, who may not receive the intervention as planned. Cross sectional surveys are better suited if a before and after intervention design is used. Lastly on-going government programs can contaminate the intervention in a before-after cross section design. However in a CRCT, the government programs will be present in both study and control clusters, so the additional impact of the intervention can be evaluated. Additionally, growth velocity and development of an infant whose mother is receiving the intervention can also be evaluated using a longitudinal design.

This design will control for potential confounding factors (Observed and unobserved) because an adequate number of clusters (292 villages) will be randomly allocated to the treatment groups. This random allocation of treatments by villages will reduce selection bias that would arise if better performing PHCs with favorable local conditions were purposely selected. Contamination of intervention will be constrained by the administrative and geographic separation of the villages, and by buffer areas.

The outcome assessments will be made by field research officers (FROs) on a cohort of 2,728 mother-infant dyads (1,364 in each treatment group) measured at baseline and at follow up visits. There will be follow-up assessments every trimester during pregnancy and every month from birth until the children are 12 months of age, and then every three or 6 months till 24 months. Three of these assessments (when infants are 15,18 & 24 months) will be made after the education intervention has ceased in order to assess the sustained impact on the prevalence of child stunting and infant feeding practices (see evaluation plan or details). The investigators expect a likely high correlation between baseline and follow up outcome measures, and low loss to follow up, thus making this approach the most efficient study design.

In this cRCT the interventions will be allocated at a community level, but the outcome assessments will be at the individual level. This is the best comparative design for the proposed interventions, which if delivered to individual mothers would most likely lead to contamination of the intervention in the densely populated rural village communities.

The proposed field area will be the centrally located villages in the catchment areas of Indian Government, PHC in 3 districts (Nagpur, Bhandara and Wardha) of eastern Maharashtra (see Map).There are around 28 PHCs.Each Primary Health Centre (PHC) covers an average population of 30,000 with an average of 30 villages. The administrative area under an ASHA is villages with population of 1000-200 (range of 751 to 2000).