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

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ClinicalTrials.gov Identifier: NCT03647553
Recruitment Status : Recruiting
First Posted : August 27, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborators:
The Hospital for Sick Children
Centre for Addiction and Mental Health
Information provided by (Responsible Party):
Dr Zulfiqar Ahmed Bhutta, Aga Khan University

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
Adolescent Development Stunting Depression Micronutrient Deficiency

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Study Type : Observational
Estimated Enrollment : 1425 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 : October 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019



Primary Outcome Measures :
  1. Stunting [ Time Frame: through study completion, an average of 1 year ]
    < -2 Height-for-age z-score


Secondary Outcome Measures :
  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:

    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03647553


Contacts
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Contact: Zulfiqar A Bhutta, PhD 92 21 3493 0051 ext 1054 zulfiqar.bhutta@sickkids.ca
Contact: Yaqub Wasan, MA 92 21 3493 0051 ext 1054 yaqub.wasan@aku.edu

Locations
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Pakistan
Matiari Research and Training Centre Recruiting
Matiari, Sindh, Pakistan
Contact: Zulfiqar A Bhutta, PhD, MBBS    011922134930051 ext 1054    zulfiqar.bhutta@sickkids.ca   
Contact: Yaqub Wasan, MA    011922134930051 ext 1054    yaqub.wasan@aku.edu   
Sponsors and Collaborators
Aga Khan University
The Hospital for Sick Children
Centre for Addiction and Mental Health

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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     History of Changes
Other Study ID Numbers: 5251-WCH-ERC-18
First Posted: August 27, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No