Clinical trial NCT06018636: Impact of Diet and Nutrition on Growth and Development in Young Children
Official title: Dietary Intake/Patterns, Nutritional Status and Their Association With Growth and Development of Children From Remote, Agropastoral Communities of District Swat, Pakistan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nutrition
Growth
Development
Stunting
Wasting
Obesity
Child Development
Keywords: Nutritional status
Malnutrition
Growth
Cognitive Development
Anthropometry
Agropastoral
remote
rural
Urban
Lead sponsor: Khyber Medical University Peshawar
Sponsor class: OTHER
Collaborators: name: University of Chester
name: University of Glasgow
name: University of Bern
First posted: 2023-08-30
Enrollment: 832
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The target population (infants and young children) residing either in rural, agro-pastoral communities or urban clusters will be recruited from the respective communities. A list of potential participants will be obtained from Extended Program on Immunization (EPI) data of available with local health facilities (Basic Health Unit).

Brief summary: The association between nutrition in early life and its long-term health consequences has long been known. However, there is a scarcity of scientific evidence on how nutritional status affects child growth and development in remote, rural agro-pastoral communities with distinct dietary intake habits, geographical location, socio-economic status, and cultures.

Detailed description: Childhood malnutrition is endemic in Pakistan. However, the agro-pastoral communities of Pakistan are at particularly high risk of childhood malnutrition due to low socioeconomic status, hard-to-reach geographic locations, harsh weather, and frequent natural disasters due to rapid climate change. Furthermore, distinct dietary habits and cultures may also influence child nutritional status and health and development in these communities. The present study aims to assess the dietary intake/patterns, nutritional status, and their association with the growth and development of children from remote, agro-pastoral communities of District Swat, Pakistan.

In this prospective cohort study from Pakistan, infants and young children (n=416) aged ≤ 2 years and residing in agro-pastoral communities of District Swat will be recruited and followed every 12 months for 5 years. An age and gender-matched comparison group of children (n=416) will also be recruited from the more urban areas of District Swat. Data on household socio-economic status, Household Food Insecurity Access Scale (HFIAS), Minimum Dietary Diversity (MDD) of Mothers, Infant and young child feeding practices (IYCF), Complimentary Feeding and Eating practices, and growth and development of the children will be assessed from baseline and every 12 months till the child is 5 years old. Anthropometric assessment including height, weight, mid-upper arm circumference (MUAC), and BMI will also be performed at each time point.

Eligibility criteria: Inclusion Criteria:

* Households living in the area from the last two 2 years.
* Households having infants or young children ≤ years.
* Households planning to reside in the same area for the next 1 year.

Exclusion Criteria:

* Children with any co-existent systemic diseases, confirmed from medical records.
* Children on continuous medications for any medical issue.
* Physically or mentally handicapped children

Primary outcomes:
measure: Impact of dietary intake/patterns on Child growth as assessed by body mass index (BMI)
timeFrame: 5 years
measure: Impact of dietary intake/patterns on Child development
timeFrame: 5 years
measure: Factors associated with child growth as assessed by changes in BMI
timeFrame: 5 years
measure: Factors associated with child development (based on Head circumference and EASQ-3)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Swat
country: Pakistan
facility: Dr. Muhammad Shahzad
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Khyber Medical University
name: Muhammad Shahzad, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ramakrishnan U. Prevalence of micronutrient malnutrition worldwide. Nutr Rev. 2002 May;60(5 Pt 2):S46-52. doi: 10.1301/00296640260130731.
citation: Roth DE, Krishna A, Leung M, Shi J, Bassani DG, Barros AJD. Early childhood linear growth faltering in low-income and middle-income countries as a whole-population condition: analysis of 179 Demographic and Health Surveys from 64 countries (1993-2015). Lancet Glob Health. 2017 Dec;5(12):e1249-e1257. doi: 10.1016/S2214-109X(17)30418-7.
citation: Lee A, Cheung CK, Lo K, Keung VM, Mui LW, Tam WWS. Studying Impact of Nutrition on Growth (SING): a prospective cohort for comparing the health outcomes of young children with the dietary quality score. BMJ Open. 2017 Nov 8;7(11):e018380. doi: 10.1136/bmjopen-2017-018380.