Evaluation of Executive Function and Emotional Regulation in Children in Bangladesh

NCT05629624 | Unknown

• 1 other identifier: M4EFaD/Dhaka PR-21084
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

The study explores the impact of malnutrition at enrollment on executive function (EF) and emotional regulation (ER) in malnourished 1-year-old children and whether specially designed brain directed therapeutic feeds improve EF/ER outcomes at three years of age. The study will detect changes in EF and ER related to nutritional rehabilitation using specially designed ready to use therapeutic feeds (E-RUSF Nutriset) during the repletion phase and maintained for two years until age 3 with enhanced E-SQLNS (small quantity lipid based nutrient supplement) also modified to provide adequate brain directed micro and macronutrients. The investigators hypothesize that standard Bangladeshi designed B-RUSF and SQLNS (Nutriset) do not provide adequate nutrients to supply the brain during the rapid catch-up growth and subsequent early childhood growth phases of rehabilitation from Moderate Acute Malnutrition (MAM). The investigators predict that the children with moderately severe malnutrition treated with E-RUSF followed by 2 years of E-SQLNS will show an exuberance of connections (higher functional connectivity) than children receiving standard Bangladeshi rehabilitation feeds B-RUSF and SQLNS. This prediction is based on past work using EEG to examine the BEAN sample in Bangladesh, and differs from the sample in Boston, where the investigators anticipate that among healthy, normally nourished children, greater connectivity will be associated with better cognitive outcomes. The Core Toolkit will be deployed to the Bangladesh site to define its utility in prediction of executive dysfunction and emotional dysregulation in the context of low-income status, malnutrition and nutritional intervention. All nutritional intervention groups of malnourished children will also receive a set psychosocial stimulation curriculum that has been shown to be effective on severely malnourished children with therapeutic feedings.

Conditions

Executive Function Disorder; Emotional Regulation; Malnutrition, Child

Keywords

Executive Function; Emotional Regulation; Malnutrition; Children; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Change in BAYLEY-4 scores from 1 year to 2 years of age

  Bayley-4 Scales of Infant and Toddler Development is standardized developmental assessment tool for determining a child's developmental status at a given age (up to 42 months) BAYLEY-4 assess development in children of 1-42 months old in 5 domains: cognition, motor, language, socio-emotional, and adaptive behavior.

  All enrolled children at 1 year ±1m(11m-13m) and 2 years ±1m(23m-25m)

Secondary Outcomes (10)

• Change in functional Near Infrared spectroscopy (fNIRS) from 1 year to 2 years of age

  All enrolled children at 1 year ±1m(11m-13m) and 2 years ±1m(23m-25m)

• Change in Electroencephalogram (EEG) power from 1 year to 2 years of age

  All enrolled children at 1 year ±1m(11m-13m) and 2 years ±1m(23m-25m)

• Change in LENA (Language Environment Analysis) from 1 year to 2 years of age

  Baseline at 1 year ±1m(11m-13m) for control and intervention and 3 years ±2m(34m-38m) for the outcome reference group, and during follow up of control and intervention group at 2 years ±1m(23m-25m) and 3 years ±2m(34m-38m) of age.

• Change in Parent-Child Interaction coded data from 1 year to 2 years of age

  All enrolled children at 1 year ±1m(11m-13m) and 2 years ±1m(23m-25m)

• Change in weight in kilograms at the start of intervention until they reach within 1 standard deviation of the mean

  Baseline, weekly, quarterly

Study Arms (4)

Chickpea based RUSF

EXPERIMENTAL

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.

Dietary Supplement: Chickpea based RUSF

E-RUSF

EXPERIMENTAL

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.

Dietary Supplement: E-RUSF

Well-nourished children

NO INTERVENTION

Well-nourished children at 1 year of age (WLZ/WHZ score \>-1 SD). No nutritional or psychosocial intervention. Only follow-up.

Outcome reference group

EXPERIMENTAL

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.

Dietary Supplement: Outcome reference group/RUSF

Interventions

Chickpea based RUSF DIETARY_SUPPLEMENT

One group will receive locally produced RUSF, approximate at 50-100 kcal/kg/day, two of 50g packets daily (42) until anthropometric recovery ( WHZ \> - 1SD) has been achieved or for maximum 3 months then immediately 1 packet / day SQLNS will be given throughout the study till the end of 2 years of follow-up.

Chickpea based RUSF

E-RUSF DIETARY_SUPPLEMENT

The other group will receive the E-RUSF at 50-100 kcal/kg/day which in this age group approximates one 92 g sachet daily until anthropometric recovery ( WHZ \> - 1SD) has been achieved or for a of maximum 3 months, then immediately E-SQLNS 1 packet daily provided throughout the study till the end of 2 years of follow-up.

E-RUSF

Outcome reference group/RUSF DIETARY_SUPPLEMENT

We will also recruit 70 three-year-old previously untreated MAM children WHZ \<-2 and ≥-3 z-score, and/or MUAC \<12.5 and ≥11.5 cm as an outcome reference group for a singular assessment. All children (both case \& control) will undergo a baseline nutritional, medical, biological and neuropsychological assessment (EF, ER, EEG and fNIRS). After all the assessments chick-pea based RUSF will be given for 2 months for nutritional rehabilitation.

Outcome reference group

Eligibility Criteria

• Age: 12 Months - 39 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Boston Children's Hospital: lead
• The University of The West Indies: collaborator
• International Centre for Diarrhoeal Disease Research, Bangladesh: collaborator
• University of Auckland, New Zealand: collaborator
• Wellcome Trust: collaborator

Study Sites (1)

International Centre for Diarrheal Disease Research

Dhaka, Bangladesh

RECRUITING

Related Publications (37)

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MeSH Terms

Conditions

Emotional Regulation; Child Nutrition Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Charles Nelson, Ph.D

  Children's Hospital Boston/Harvard University

  PRINCIPAL INVESTIGATOR

• Terrence Forrester, Dr

  University of the West Indies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles Nelson, Ph.D.

CONTACT

617-355-0401; Charles_Nelson@harvard.edu

Terrence Forrester, Dr

CONTACT

(876) 977-6803; Terrence.Forrester@uwimona.edu.jm

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics and Neuroscience

Model Details: We will recruit a sample of malnourished children and randomly assign to different intervention arms. We will also have a control sample of well-nourished children for comparison analysis.

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: November 29, 2022
• Study Start: February 7, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: At the end of the study, all of the specimens will be stored at icddr,b for 5 years.
• Access Criteria: We will keep all information collected from you and your child confidential and locked in a secure place under the responsibility of the study investigators. Data will be saved in secure servers at icddr,b and Boston Children's Hospital. Biological samples will be stored securely without identifying information at icddr,b. Neuro imaging testing will be done in private rooms, and subjects will be coded by a de-identified number. In addition, staff and researchers have completed the Course in The Protection of Human Research Subjects.

Locations

BA (1)