Table 2 List of study outcomes. For each of the outcomes, the difference between the intervention and control groups at 4Â months post-intervention and 15Â months post-intervention (primary assessment time) will be calculated
Outcome category | Description | Method | Units |
|---|---|---|---|
Primary outcomes | |||
 Water and food safety and hygiene behaviour | The number of events during child’s water and food preparation and handling where the mother has an opportunity to practice a pre-specified drinking water and complementary-food safety and hygiene behaviour in which the behaviour is observed (e.g. hand washing before food preparation) of all total opportunities in the observation period | Observation (number not fixed) | Number of opportunities met (binomial) |
 Food and water contamination | E. coli count in child’s food and water samples | Sample collection and field testing | Colony-forming units/gramme (cfu/g) (count) |
 Diarrhoea | Observation of stool consistency (watery diarrhoea) [22] by field data collectors and history of at least 2 other such stools in the last 24 h | Observation of collected stool by a fieldworker | Dichotomous |
Secondary outcomes | |||
 Implementation | |||
  Fidelity | Number of visits of the intervention delivered as planned | Investigator report | Count |
  Uptake | Number of mothers who reported the intervention (Table 1) | Survey | Count |
 Knowledge and behaviour | |||
  Nutrition | Minimum acceptable diet based on minimum dietary diversity and minimum meal frequency they are fed during the day (DHS survey, see below) | Survey | Dichotomous |
  Geophagy | Number of behaviours observed from total opportunities in the assessment of child play environment and behaviour over the observation period | Observation (number not fixed) | Number of opportunities met (binomial) |
  Maternal autonomy | Women’ s Autonomy Measure (from DHS survey). Proportion (of n = 9) of household decisions the woman participates in | Survey | Number of opportunities met (binomial) |
 Short-term microbiological and clinical outcomes | |||
  Acute respiratory infection | Parental report of cough and difficulty breathing in past 7 days | Survey | Dichotomous |
  Diarrhoea hospitalisation | In-patient hospitalisation (if given a bed to stay for observation, tests, or treatment for > 3 h) for diarrhoeal disease in the past 3 months | Survey | Dichotomous |
  Enteric infection | Qualitative PCR of the following pathogens: ETEC, EAEC, EPEC, astrovirus, sapovirus, rotavirus, adenovirus, Giardia, Cryptosporidium, Entamoeba histolytica | Sample collection and lab testing | Dichotomous (for each pathogen) |
Long-term physiological outcomes | |||
 Physical growth | Weight | On site measurement | Weight for age (z-score [WHO International Growth Tables]) |
 Physical growth | Height | On site measurement | Height for age (z-score [WHO International Growth Tables]) |
 Cognitive development | ASQ3 score for age | Survey/observation | Count |