Methylation, mIcrobiome, NUtritional sTatus, and dEvelopment of Stunted Children (MINUTES)

July 2, 2024 updated by: Dr.Umi Fahmida, SEAMEO Regional Centre for Food and Nutrition

DNA Methylation, Microbiome Profile, Nutritional Status, and Developmental Outcomes of Stunted and Non-stunted Children Growing up During Covid-19 Pandemic: a Case-control Study

The investigators will conduct a case-control study among under-two children in Lombok Timur, West Nusa Tenggara, Indonesia. The power required to detect changes in epigenetic markers may not be sufficient in the cohort study. Therefore, specific case-control design of stunted vs non-stunted children will provide the required power to detect potential epigenetic markers which will be further investigated through targeted sequencing of the cohort study. A total of 150 stunted children will be recruited and then it will be matched with 150 non-stunted children with the same sex. The assessments for these study subjects will include: 1) The genetic and epigenetic profile of the children, gut microbiota and nutritional status (Physical component), 2) Food security, Water, Sanitation and Hygiene (WASH) and Infant and Young Child Feeding (IYCF) practices (Home-Food component), 3) Children's psychosocial care and cognitive outcome (Cognition component).

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This study is part of Action Against Stunting Hub, an observational cohort study aimed to build evidence based on exploring the drivers of stunting from different perspectives and understand the impact of different interventions across three countries: India, Indonesia and Senegal. This study is intended to give the overview of stunting and its determinants among under-two children growing up during period of Covid-19 pandemic in Lombok Timur, Nusa Tenggara Barat, Indonesia. Because, the power required to detect changes in epigenetic markers may not be sufficient in the cohort study, this specific case-control design of stunted vs non-stunted children will also provide the required power to detect potential epigenetic markers which will be further investigated through targeted sequencing of the cohort study. The results of this initial study are projected to support further study, especially the observational cohort study, in determining the best suited indicators to prove the interaction and/or causal mechanisms of stunting.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 10430
        • Seameo Recfon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 1 year (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A total of 150 stunted children (case) will be recruited and then it will be matched with 150 non-stunted children (control) with the same sex. Before the screening time, data of children aged 18.0-23.9 months from Posyandu will be listed. The field team will coordinate with midwives to inform the children and their guardian to get screened. Screening for eligibility criteria will be done for all children aged 18.0-23.9 months that has listed in the previous visit. Length measurement for the children and checklist of eligibility criteria will be done during the screening time by trained enumerators. After fulfilling the eligibility criteria, the enumerators have to determine to matched children based on their gender.

Description

Inclusion Criteria:

  • aged 18.0 - 23.9 months
  • without serious illnesses
  • the mother delivered the children between 18-40 years of age
  • has Sasak ethnicity, (5) recumbent length <-2SD (for stunted group) and >-1SD (for non- stunted group) from the WHO Child Growth Standards median for their age and sex at the recruitment.

Exclusion Criteria:

  • twin birth
  • congenital malformation
  • consanguinity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Stunted (Case)
In the case group, stunted children (<-2SD) (n=150) will be recruited.
Non-stunted (Control)
In the control group, non-stunted children (>-1SD) (n=150) will be recruited.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epigenetics signature related to stunting
Time Frame: at enrollment
Analysis of epigenetic states (DNA methylation) will be carried out using the Illumina Infinium Methylation EPIC V.2.0 BeadChip, augmented by sequencing methodologies to provide both genome wide coverage and high-definition analysis. Epigenetic state controls gene expression and overall genome regulation at scale and the study will focus on candidate epigenetic states implicated in stunting and its corollaries alongside epigenome wide association.
at enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Child congnition outcomes (by psychologists)
Time Frame: at enrollment

Cognitive development will be assessed using the full Bayley Scales of Infant and Toddler Development (BSID-4) by trained psychologists. BSID-4 consists of: Cognitive Scale (COG); Language Scale (LANG), and Motoric Scale (MOT).

The range of Standard Score (SS) of each scale is 40-160 in which higher score means better.
at enrollment
Child cognition outcomes (care giver reported)
Time Frame: at enrollment

Cognitive development will be assessed using the care giver reported tool, i.e., INTERGROWTH-21st Neurodevelopment assessment INTER-NDA by trained enumerators. INTER-NDA consists of: Cognitive; Fine motor; Gross motor; Language; Positive behavior; Negative behavior.

The range of score on each scale is 0 - 100 in which higher score means better.
at enrollment
Gut microbiome
Time Frame: at enrollment
Faecal microbiome would be analyzed using 16S RNA sequencing of the V4 region on the Illumina MiSeq platform
at enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SEAMEO Regional Centre for Food and Nutrition

Collaborators

London School of Hygiene and Tropical Medicine
University of Aberdeen

Investigators

  • Principal Investigator: Umi Fahmida, Dr., Seameo Recfon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

February 6, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 22, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AASH Early Year Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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