- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03647553
The Nash-wo-Numa (Childhood Growth & Development) Study
July 26, 2021 updated by: Dr Zulfiqar Ahmed Bhutta, Aga Khan University
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
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
1385
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
-
-
Sindh
-
Matiari, Sindh, Pakistan
- Matiari Research and Training Centre
-
-
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
9 years to 15 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The study will be conducted in Matiari District in the Province of Sindh, Pakistan.
The population of Matiari (2017) was estimated to be 769,349 with approximately 85% being rural.
There are approximately 48,000 school-aged children between 9.0 and 15.9 years of age living in the District, which is representative of rural conditions in Pakistan.
Description
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).
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stunting
Time Frame: through study completion, an average of 1 year
|
< -2 Height-for-age z-score
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
through study completion, an average of 1 year
|
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
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
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.
|
through study completion, an average of 1 year
|
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:
|
through study completion, an average of 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
- Campisi SC, Humayun KN, Wasan Y, Soofi SB, Islam M, Hussain A, Shakeel A, Vandermorris A, Soder O, Bhutta ZA. The relationship between pubertal timing and under-nutrition in rural Pakistan. J Adolesc. 2021 Apr;88:58-66. doi: 10.1016/j.adolescence.2021.02.002. Epub 2021 Feb 19.
- Campisi SC, Wasan Y, Soofi S, Monga S, Korczak DJ, Lou W, Soder O, Vandermorris A, Humayun KN, Mian A, Szatmari P, Bhutta ZA. Nash-wo-Numa (childhood growth & development) study protocol: factors that impact linear growth in children 9 to 15 years of age in Matiari, Pakistan. BMJ Open. 2019 Jun 12;9(6):e028343. doi: 10.1136/bmjopen-2018-028343.
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)
October 1, 2018
Primary Completion (ACTUAL)
February 28, 2020
Study Completion (ACTUAL)
March 31, 2021
Study Registration Dates
First Submitted
August 23, 2018
First Submitted That Met QC Criteria
August 23, 2018
First Posted (ACTUAL)
August 27, 2018
Study Record Updates
Last Update Posted (ACTUAL)
July 28, 2021
Last Update Submitted That Met QC Criteria
July 26, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5251-WCH-ERC-18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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