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NCT Number: NCT03647553

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

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.

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Key information

Conditions

Adolescent Development Behavior Behavioral Symptoms Depression Growth Disorders Micronutrient Deficiency Pathologic Processes Pathological Conditions, Signs and Symptoms Stunting

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Matiari Research and Training Centre

Matiari, Sindh, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Stunting

    Time frame: through study completion, an average of 1 year

    < -2 Height-for-age z-score

Secondary outcomes

  1. Factors associated with impaired linear growth

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Aga Khan University

Other

Collaborators

  • Centre for Addiction and Mental Health
  • The Hospital for Sick Children

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Aug 27, 2018
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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