- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06018636
Impact of Diet and Nutrition on Growth and Development in Young Children (DIGEST)
Dietary Intake/Patterns, Nutritional Status and Their Association With Growth and Development of Children From Remote, Agropastoral Communities of District Swat, Pakistan
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Muhammad Shahzad, PhD
- Phone Number: 00923459048796
- Email: shahzad.ibms@kmu.edu.pk
Study Contact Backup
- Name: Ahsan Saidal, MHR
- Phone Number: 00923348294105
- Email: ahsan.ipms@kmu.edu.pk
Study Locations
-
-
Khyber Pakhtunkhwa
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Swat, Khyber Pakhtunkhwa, Pakistan, 19040
- Recruiting
- Dr. Muhammad Shahzad
-
Contact:
- Muhammad Shahzad, PhD
- Phone Number: 00923459048796
- Email: shahzad.ibms@kmu.edu.pk
-
Contact:
- Ahsan Saidal, MHR
- Phone Number: 00923348294105
- Email: ahsan.ipms@kmu.edu.pk
-
Principal Investigator:
- Ahsan Saidal, MHR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Group 1
Infants and young children residing in agropastoral communities of District Swat, Pakistan
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Group 2
Infant and young children residing in urban areas of district Swat, Pakistan
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
5 years
|
|
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.
|
5 years
|
|
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.
|
5 years
|
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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).
|
5 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Muhammad Shahzad, PhD, Khyber Medical University
Publications and helpful links
General Publications
- Ramakrishnan U. Prevalence of micronutrient malnutrition worldwide. Nutr Rev. 2002 May;60(5 Pt 2):S46-52. doi: 10.1301/00296640260130731.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Nutrition & Child Development
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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