Methylation, mIcrobiome, NUtritional sTatus, and dEvelopment of Stunted Children

NCT ID: NCT05779904

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-05
• Study Completion Date: 2024-09-30

Brief Summary

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).

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.

Conditions

Stunting; Development, Child; DNA Methylation; Epigenetics; Nutrition

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Stunted (Case)

In the case group, stunted children (\<-2SD) (n=150) will be recruited.

No interventions assigned to this group

Non-stunted (Control)

In the control group, non-stunted children (\>-1SD) (n=150) will be recruited.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role: collaborator

University of Aberdeen

OTHER

Sponsor Role: collaborator

SEAMEO Regional Centre for Food and Nutrition

OTHER

Sponsor Role: lead

Responsible Party

Dr.Umi Fahmida

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Umi Fahmida, Dr.

Role: PRINCIPAL_INVESTIGATOR

SEAMEO RECFON

Locations

Seameo Recfon

Jakarta, , Indonesia

Countries

Indonesia

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Other Identifiers

AASH Early Year Study

Identifier Type: -

Identifier Source: org_study_id