Evaluation of Executive Function and Emotional Regulation in Children in Bangladesh
Executive Function Disorder, Emotional Regulation, Malnutrition, Child
About this trial
This is an interventional health services research trial for Executive Function Disorder focused on measuring Executive Function, Emotional Regulation, Malnutrition, Children, Bangladesh
Eligibility Criteria
Inclusion criteria: Inclusion criteria for malnourished (MAM) children at 1 and 3 years of age: All of the following criteria must be met for a subject to be eligible to participate in the study Mother willing to sign consent form Child age 12-15 months or 36-39 months of age WHZ <-2 and ≥-3 z-score, and/or MUAC <12.5 and ≥11.5 cm and free from any acute illness Mother agrees to feed their children a study diet at home. Mother willing to bring the child to the clinic for assessment (morbidity, nutrition history, adherence to treatment, anthropometry and advice to mother on parenting) and clinical examination. Mother will agree to provide her biological samples Mother willing to have a child undergo biological sample collection and neuropsychological assessment at baseline (1-year-old) and at ages 2 years and 3 years at the clinic. Family has no plan to move from the study area in the next three years. Inclusion criteria for Control group with normal health (normal Z score): Mother willing to sign consent form Child age 12-15 months WHZ score > -1 and free from any acute illness Mother willing to bring the child to the clinic for assessment (morbidity, nutrition history, adherence to treatment, anthropometry and advice to mother on parenting) and clinical examination. Mother will agree to provide her biological samples (see below). Mother willing to have a child undergo biological sample collection and neuropsychological assessment at baseline at 1 year old and again at 2 years and 3 years at the clinic. Family has no plan to move from the study area in the next two years. Exclusion Criteria: Exclusion criteria for malnourished (MAM) children: Meeting any of the following criteria will exclude a subject from study participation Mother who is not willing to sign a consent form. Congenital anomaly. Mother who is not willing to feed the rehabilitation feed or the small quantity supplement to her child. Family will not stay 3 years in the study area. Exclusion criteria for Control group with normal health (normal Z score): Meeting any of the following criteria will exclude a subject from study participation - Mother who is not willing to sign a consent form. Child age >15 months or < 12m. Mother who is not willing to feed the rehabilitation feed or the small quantity supplement to her child. Family will not stay 3 years in the study area. Any congenital anomaly.
Sites / Locations
- International Centre for Diarrheal Disease ResearchRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
No Intervention
Experimental
Chickpea based RUSF
E-RUSF
Well-nourished children
Outcome reference group
Locally produced ready to use supplementary food (RUSF), 50 g/packet contains 204 kcal energy). Two packets of RUSF provided for consumption at a rate of 50-100 kcal/kg/day till the child's weight for height returns to normal (WHZ >-1SD) or for maximum 3 months.
Enhanced Ready to use therapeutic feeds (E-RUSF), 50-100 kcal/kg/d daily until for anthropometric recovery (WHZ > - 1SD) is achieved or for maximum 3 months then E-SQLNS will be given till the end of 2 years follow-up.
Well-nourished children at 1 year of age (WLZ/WHZ score >-1 SD). No nutritional or psychosocial intervention. Only follow-up.
3 year olds previously untreated MAM children (WHZ <-2 and ≥-3 z-score, and/or MUAC <12.5 and ≥11.5 cm) and free from any acute illness will be used as the outcome reference group.