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

Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03647553
• Other study ID #: 5251-WCH-ERC-18
• Status: Completed
• Start date: October 1, 2018
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2021
• Source: Aga Khan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1385
• Est. completion date: March 31, 2021
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adolescent Development
• Depression
• Growth Disorders
• Micronutrient Deficiency
• Stunting

Locations

Country	Name	City	State
Pakistan	Matiari Research and Training Centre	Matiari	Sindh

Sponsors (3)

Lead Sponsor	Collaborator
Aga Khan University	Centre for Addiction and Mental Health, The Hospital for Sick Children

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stunting	< -2 Height-for-age z-score	through study completion, an average of 1 year
Secondary	Factors associated with impaired linear growth	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	through study completion, an average of 1 year
Secondary	Anemia and micronutrient deficiencies	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	through study completion, an average of 1 year
Secondary	Household Dietary Diversity Scale (HDDS)	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.	through study completion, an average of 1 year
Secondary	Food Insecurity Experience Scale (FIES)	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.	through study completion, an average of 1 year
Secondary	Anxiety	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.	through study completion, an average of 1 year
Secondary	Depression	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.	through study completion, an average of 1 year
Secondary	Pubertal status	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.	through study completion, an average of 1 year