Clinical trial NCT03647553: The Nash-wo-Numa (Childhood Growth & Development) 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Development
Stunting
Depression
Micronutrient Deficiency
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: The Hospital for Sick Children
name: Centre for Addiction and Mental Health
First posted: 2018-08-27
Enrollment: 1385
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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.


Eligibility 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).

Primary outcomes:
measure: Stunting
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Factors associated with impaired linear growth
timeFrame: through study completion, an average of 1 year
measure: Anemia and micronutrient deficiencies
timeFrame: through study completion, an average of 1 year
measure: Household Dietary Diversity Scale (HDDS)
timeFrame: through study completion, an average of 1 year
measure: Food Insecurity Experience Scale (FIES)
timeFrame: through study completion, an average of 1 year
measure: Anxiety
timeFrame: through study completion, an average of 1 year
measure: Depression
timeFrame: through study completion, an average of 1 year
measure: Pubertal status
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Matiari
country: Pakistan
facility: Matiari Research and Training Centre
state: Sindh
Study officials:
References:
citation: 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.
citation: 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.