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Adolescent DevelopmentNCT03647553

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

An observational study of Adolescent Development and Stunting, run by Aga Khan University at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 9 to 15 yearsHealthy volunteers can take part
Conditions the study is for
Adolescent Development, Stunting, Depression
How many people
1,385 participants
Where
1 sitePakistan
Study dates
1 Oct 2018to 31 Mar 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 15 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Who may be able to join

  • 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

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Matiari Research and Training Centre

    Matiari, Sindh

Other trials in Pakistan

About this study

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

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.

Medical subject headings
Growth Disorders, Depression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stunting

    < -2 Height-for-age z-score

    Measured: through study completion, an average of 1 year

Secondary outcomes (7)

  1. 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

    Measured: through study completion, an average of 1 year

  2. 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

    Measured: through study completion, an average of 1 year

  3. 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.

    Measured: through study completion, an average of 1 year

  4. 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.

    Measured: through study completion, an average of 1 year

  5. 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.

    Measured: through study completion, an average of 1 year

  6. 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.

    Measured: through study completion, an average of 1 year

  7. 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:

    1. Self-Assessment: All participants will be asked a series of questions similar to a medical history to determine their Pubertal Phase ;
    2. 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.

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2018
  2. Study start1 Oct 2018
  3. Primary completion28 Feb 2020
  4. Study completion31 Mar 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
1,385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03647553
Sponsor's protocol ID
5251-WCH-ERC-18
Status last verified
Jul 2021
First submitted
23 Aug 2018
Last updated
28 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 33618265

  • 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.

    PubMed 31196903

Questions about this trial

What is this clinical trial studying?

An observational study of Adolescent Development and Stunting, run by Aga Khan University at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stunting (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03647553, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.

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