The Nash-wo-Numa (Childhood Growth & Development) Study

Sponsor
Aga Khan University (Other)
Overall Status
Completed
CT.gov ID
NCT03647553
Collaborator
The Hospital for Sick Children (Other), Centre for Addiction and Mental Health (Other)
1,385
1
30
46.2

Study Details

Study Description

Brief Summary

The proposed study will be a cross-sectional study in the District of Matiari, Pakistan. Children ages 9-15 years will be identified from a Matiari District household census scheduled being conducted from December 2016- to May 2017 by the Department of Pediatrics and Child Health, Aga Khan University. Anthropometric measures, Tanner Stage, Hemoglobin concentration, blood draw as well as questionnaires will be assessed in all participants.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1385 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    The Nash-wo-Numa (Childhood Growth & Development) Study : Factors That Impact Linear Growth and Mental Health in Children 9-15 Years of Age in Matiari, Pakistan
    Actual Study Start Date :
    Oct 1, 2018
    Actual Primary Completion Date :
    Feb 28, 2020
    Actual Study Completion Date :
    Mar 31, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Stunting [through study completion, an average of 1 year]

      < -2 Height-for-age z-score

    Secondary Outcome Measures

    1. Factors associated with impaired linear growth [through study completion, an average of 1 year]

      To identify factors associated with impaired linear growth among girls between 9-14.9 years of age and boys 10-15.9 years of age living in Matiari

    2. Anemia and micronutrient deficiencies [through study completion, an average of 1 year]

      To determine the prevalence of anemia and micronutrient deficiencies among girls between 9-14.9 years of age and boys 10-15.9 years of age living in Matiari

    3. Household Dietary Diversity Scale (HDDS) [through study completion, an average of 1 year]

      The HDDS reflects household access to food variation and is a count of the food groups consumed over a given reference period. The value of this variable will range from 0 to 12 and represents the total number of food groups consumed.

    4. Food Insecurity Experience Scale (FIES) [through study completion, an average of 1 year]

      FIES was developed in 2013 by the FAO for global and country monitoring of the severity of food insecurity in the previous 12 months. Since 2014, the Gallup World Poll (GWP) has collected data using the FIES. The FIES consists of eight dichotomous questions and results range on a scale from mild to severe food insecurity. Results are classified based on the total number of affirmative responses ranging from 0-8. While the FIES does not measure food insecurity directly in children, estimates of the percentage of children living in food-insecure households are generally used.

    5. Anxiety [through study completion, an average of 1 year]

      To access the presalence of anxiety we will be using the Screen for Child Anxiety Related Disorders (SCARED). This instrument contains 41 items and measures anxiety using four domains: panic/somatic, separation anxiety, generalized anxiety, and school phobia. A total score >25 indicates an anxiety disorder.

    6. Depression [through study completion, an average of 1 year]

      To determine the prevalence of depression among girls between 9-14.9 years of age and boys 10-15.9 years of age living in Matiari. We will be using the Mood and Feeling questionnaire to assess depression. A score > 27 may indicate the presence of depression.

    7. Pubertal status [through study completion, an average of 1 year]

      To determine the prevalence of pubertal status (pre-puberty, in-puberty, completing puberty) according to chronological age among girls between 9-14.9 years of age and boys 10-15.9 years of age living in Matiari using culturally sensitive methods. Puberty assessment for this study will be composed of two components: Self-Assessment: All participants will be asked a series of questions similar to a medical history to determine their Pubertal Phase ; Physical Assessment: Participants also willing to participate in a modified physical examination for Tanner Stage assessment. Puberty Phase classification after Tanner Stage assessment. Study staff will confirm assent and consent for each physical Tanner Stage assessment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • All girls between 9.0-14.9 years of age and boys between 10.0-15.9 years of age at the time of enrollment who are permanent residents of Matiari are eligible to participate in the Nash-wo-Numa Study.

    • The participant's birth mother must also be available to participate in the study and be cognitively able to answer questions since they will be able to provide more accurate information about the birth characteristics of the participant as well as household information like dietary intake

    Exclusion Criteria:
    • Children not meeting the age criteria will not be invited to participate in the study. Female participants who are pregnant or have been pregnant will be excluded from the study.

    • Participants must not be participating in any other nutrition trials. Participants with known chronic or genetic diseases that impact growth will be excluded.

    • An illustrative list of conditions include: congenital heart disease, metabolic disorders (e.g. diabetes), cancer, genetic disorders (Down's syndrome, Turner's syndrome), blood disorders (symptomatic thalassemia, sickle cell anaemia), chronic disorders (kidney i.e. nephrotic syndrome, gastrointestinal i.e. Crohn's, bone dysplasia, immunodeficiency disorders).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Matiari Research and Training Centre Matiari Sindh Pakistan

    Sponsors and Collaborators

    • Aga Khan University
    • The Hospital for Sick Children
    • Centre for Addiction and Mental Health

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Zulfiqar Ahmed Bhutta, Founding Director of the Center of Excellence in Women and Child Health, Aga Khan University
    ClinicalTrials.gov Identifier:
    NCT03647553
    Other Study ID Numbers:
    • 5251-WCH-ERC-18
    First Posted:
    Aug 27, 2018
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2021