Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Child Growth: Changes in length-for-age Z-score (LAZ) |
Child length or height will be measured in centimeters (cm). Length-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months. |
Baseline and months 3, 6, 9, and 12 |
|
Primary |
Child Growth: Changes in weight-for-age Z-score (WAZ) |
Child weight will be measured in kilograms (kg). Weight-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months. |
Baseline and months 3, 6, 9, and 12 |
|
Primary |
Child Growth: Changes in head circumference-for-age Z-score (HCZ) |
Child head circumference will be measured in centimeters (cm). Head circumference-for-age Z-scores will be calculated using the World Health Organization (WHO) growth standards, accounting for the child sex and age in months. |
Baseline and months 3, 6, 9, and 12 |
|
Primary |
Child Development: Changes in ASQ- Socio-Emotional (ASQ-SE) score |
The Ages & Stages Questionnaire: Socio-Emotional Questionnaire (ASQ-SE2) will be used to assess and score child socio-emotional development. |
Baseline and months 6 and 12 |
|
Primary |
Child Development: Changes in ASQ Communication score |
The Ages & Stages Questionnaire (ASQ-3) will be used to assess and score children's communication skills. |
Baseline and months 6 and 12 |
|
Primary |
Child Development: Changes in ASQ Gross Motor score |
The Ages & Stages Questionnaire (ASQ-3) will be used to assess and score children's gross motor development. |
Baseline and months 6 and 12 |
|
Primary |
Child Development: Changes in ASQ Fine Motor score |
The Ages & Stages Questionnaire (ASQ-3) will be used to assess and score children's fine motor development. |
Baseline and months 6 and 12 |
|
Primary |
Child Development: Changes in ASQ Problem Solving score |
The Ages & Stages Questionnaire (ASQ-3) will be used to assess and score children's problem solving skills. |
Baseline and months 6 and 12 |
|
Secondary |
Child Nutrient Biomarkers: Changes in Plasma Concentration of Docosahexaenoic acid (DHA) |
Plasma concentration of DHA measured in µg/mL |
Baseline and month 6 |
|
Secondary |
Child Nutrient Biomarkers: Changes in Plasma Concentration of Choline |
Plasma concentration of Choline measured in µg/mL |
Baseline and month 6 |
|
Secondary |
Child Nutrient Biomarkers: Changes in Plasma Concentration of Iron (Fe) |
Plasma concentration of Iron (Fe) measured in mg/mL |
Baseline and month 6 |
|
Secondary |
Child Nutrient Biomarkers: Changes in Plasma Concentration of Zinc (Zn) |
Plasma concentration of Zinc (Zn) measured in mg/mL |
Baseline and month 6 |
|
Secondary |
Child Nutrient Biomarkers: Changes in Plasma Concentration of Iodine (I) |
Plasma concentration of Iodine (I) measured in mg/mL |
Baseline and month 6 |
|
Secondary |
Child Nutrient Biomarkers: Changes in Plasma Concentration of Selenium (Se) |
Plasma concentration of Selenium (Se) measured in µg/mL |
Baseline and month 6 |
|
Secondary |
Child Bone Health: Changes in Bone Age Z-score |
Bone age z-scores are used as a measure of the child's bone health. |
Baseline and months 3, 6, and 12 |
|
Secondary |
Child Dietary Intake |
24-hour recalls and food frequency recalls are used to assess nutrient intakes, dietary diversity, and consumption of Animal-Source Foods (ASFs). |
Baseline and months 6 and 12 |
|
Secondary |
Responsive Parenting: Changes in PICCOLO Affection Score |
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) will be used to assess parent-child interactions, and a score for Affection will be calculated based on questionnaire items. |
Baseline and months 6 and 12 |
|
Secondary |
Responsive Parenting: Changes in PICCOLO Responsiveness Score |
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) will be used to assess parent-child interactions, and a score for Responsiveness will be calculated based on questionnaire items. |
Baseline and months 6 and 12 |
|
Secondary |
Responsive Parenting: Changes in PICCOLO Encouragement Score |
Parenting Interactions with Children: Checklist of Observations Linked to Outcomes (PICCOLO) will be used to assess parent-child interactions, and a score for Encouragement will be calculated based on questionnaire items. |
Baseline and months 6 and 12 |
|
Secondary |
Responsive Parenting: Changes in HOME Scores |
The Home Observation Measurement of the Environment (HOME) inventory will be used in assessing the home environment. |
Baseline and months 6 and 12 |
|
Secondary |
Child Morbidities |
Diarrhea, respiratory conditions, allergies. |
Baseline and months 3, 6, 9, 12 |
|