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

Obesity Clinical Trial

— DIGEST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06018636
• Other study ID #: Nutrition & Child Development
• Status: Recruiting
• Start date: June 28, 2023
• Est. completion date: September 30, 2028

Study information

• Verified date: May 2024
• Source: Khyber Medical University Peshawar
• Contact: Muhammad Shahzad, PhD
• Phone: 00923459048796
• Email: shahzad.ibms[@]kmu.edu.pk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 832
• Est. completion date: September 30, 2028
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Child Development
• Development
• Growth
• Growth Disorders
• Nutrition
• Obesity
• Stunting
• Wasting

Locations

Country	Name	City	State
Pakistan	Dr. Muhammad Shahzad	Swat	Khyber Pakhtunkhwa

Sponsors (3)

Lead Sponsor	Collaborator
Khyber Medical University Peshawar	University of Chester, University of Glasgow

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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