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NCT Number: NCT06018636

Impact of Diet and Nutrition on Growth and Development in Young Children

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.

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Key information

Conditions

Nutrition Body Weight Body Weight Changes Cachexia Child Development Development Growth Growth Disorders Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Stunting Thinness Wasting Weight Loss

Age range

1 day–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Impact of dietary intake/patterns on Child growth as assessed by body mass index (BMI)

    Time frame: 5 years

    Child growth will be assessed through changes in Body Mass Index (BMI) from baseline and each year till the child is 5 years of age. The formula is BMI = kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. These data will be categorised further on the basis of the dietary intake patterns of the children as assessed by Infant and Young child feeding practices (IYCF) questionnaire.

  2. Impact of dietary intake/patterns on Child development

    Time frame: 5 years

    Assessment of child development from baseline and each year till the child is 5 years of age. Child development will be assessed by changes in Head circumference and a validated questionnaire (Extended Ages and Stages Questionnaire-3). The EASQ-3 contains 21 questions, targeting child's Communication, Gross motor, Fine motor, Problem solving and Personal-Social skills, each having a total score of 0-60 and cut-off value at 22.77, 41.84, 30.16, 24.62 and 33.71, respectively. Score below the cut-off value indicates possible developmental delays while score slightly above the cut-off value indicates further learning activities and monitoring.

  3. Factors associated with child growth as assessed by changes in BMI

    Time frame: 5 years

    The relationship between child growth and socio-demographic characteristics of the parents, household food insecurity, mother dietary intake (minimum dietary diversity score), and childhood trauma (assessed through Childhood Trauma Scale). CTS is a validated questionnaire containing 16 questions on 04 different aspects trauma i.e., Physical Neglect, Physical Abuse, Emotional Neglect and Emotional Abuse. Total score ranges from 0-80 while 0-20 for each section. Each section has four different cut-off values indicating None, Low, Moderate or Severe neglect/abuse.

  4. Factors associated with child development (based on Head circumference and EASQ-3)

    Time frame: 5 years

    The relationship between child development and socio-demographic characteristics of the parents, household food insecurity, mother dietary intake (minimum dietary diversity score), and childhood trauma (assessed through Childhood Trauma Scale).

Study contacts

Contact information is provided by the study sponsor or research team.

Ahsan Saidal, MHR

CONTACT

[email protected]

00923348294105

Muhammad Shahzad, PhD

CONTACT

[email protected]

00923459048796

Sponsors and collaborators

Lead sponsor

Khyber Medical University Peshawar

Other

Collaborators

  • University of Bern
  • University of Chester
  • University of Glasgow

Registry information

Official study title

Dietary Intake/Patterns, Nutritional Status and Their Association With Growth and Development of Children From Remote, Agropastoral Communities of District Swat, Pakistan

Acronym: DIGEST

Important dates

Study start
2023
Primary completion
2025
Study completion
2028
First posted
Aug 30, 2023
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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