NCT06018636

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
832

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Jun 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Jun 2023Sep 2028

Study Start

First participant enrolled

June 28, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Expected
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

2.2 years

First QC Date

August 6, 2023

Last Update Submit

January 6, 2026

Conditions

Keywords

Nutritional statusMalnutritionGrowthCognitive DevelopmentAnthropometryAgropastoralremoteruralUrban

Outcome Measures

Primary Outcomes (4)

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

    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.

    5 years

  • Impact of dietary intake/patterns on Child development

    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.

    5 years

  • Factors associated with child growth as assessed by changes in BMI

    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.

    5 years

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

    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).

    5 years

Study Arms (2)

Group 1

Infants and young children residing in agropastoral communities of District Swat, Pakistan

Group 2

Infant and young children residing in urban areas of district Swat, Pakistan

Eligibility Criteria

Age1 Day - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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).

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Muhammad Shahzad

Swat, Khyber Pakhtunkhwa, 19040, Pakistan

RECRUITING

Related Publications (3)

  • Ramakrishnan U. Prevalence of micronutrient malnutrition worldwide. Nutr Rev. 2002 May;60(5 Pt 2):S46-52. doi: 10.1301/00296640260130731.

    PMID: 12035858BACKGROUND
  • 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.

    PMID: 29132614BACKGROUND
  • 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.

    PMID: 29122800BACKGROUND

MeSH Terms

Conditions

Growth DisordersCachexiaObesityMalnutrition

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsWeight LossBody Weight ChangesBody WeightSigns and SymptomsThinnessOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Muhammad Shahzad, PhD

    Khyber Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Shahzad, PhD

CONTACT

Ahsan Saidal, MHR

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2023

First Posted

August 30, 2023

Study Start

June 28, 2023

Primary Completion

August 31, 2025

Study Completion (Estimated)

September 30, 2028

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations