NutritionDIGESTNCT06018636
Impact of Diet and Nutrition on Growth and Development in Young Children
An observational study of Nutrition and Growth, run by Khyber Medical University Peshawar at 1 site in Pakistan.
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… Read more about this study
- Who is it for?
- Ages 1 day to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Nutrition, Growth, Development
- How many people
- 832 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Jun 2023to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 24 months
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 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.
Who cannot join
- Children with any co-existent systemic diseases, confirmed from medical records.
- Children on continuous medications for any medical issue.
- Physically or mentally handicapped children
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Dr. Muhammad Shahzad
Swat, Khyber Pakhtunkhwa, 19040
Muhammad Shahzad, PhD, 00923459048796, shahzad.ibms@kmu.edu.pk
Ahsan Saidal, MHR, 00923348294105, ahsan.ipms@kmu.edu.pk
About this study
Official title: Dietary Intake/Patterns, Nutritional Status and Their Association With Growth and Development of Children From Remote, Agropastoral Communities of District Swat, Pakistan
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.
Read the 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.
- Keywords
- Nutritional status, Malnutrition, Growth, Cognitive Development, Anthropometry, Agropastoral, remote, rural, Urban
- Medical subject headings
- Growth Disorders, Cachexia, Obesity, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2023
- Study start28 Jun 2023
- Primary completion31 Aug 2025
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 832 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Medical University Peshawar
- Sponsor type
- University, hospital or other
- Collaborators
- University of Chester, University of Glasgow, University of Bern
- Responsible party
- Sponsor
- Investigators
- Muhammad Shahzad, PhD, Principal investigator, Khyber Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06018636
- Sponsor's protocol ID
- Nutrition & Child Development
- Acronym
- DIGEST
- Status last verified
- Jan 2026
- First submitted
- 6 Aug 2023
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ramakrishnan U. Prevalence of micronutrient malnutrition worldwide. Nutr Rev. 2002 May;60(5 Pt 2):S46-52. doi: 10.1301/00296640260130731.
PubMed 12035858Roth 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.
PubMed 29132614Lee 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.
PubMed 29122800
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intake/Patterns, Nutritional Status and Their Association With Growth and Development of Children From Remote, Agropastoral Communities of District Swat, Pakistan
- ClinicalTrials.gov ID
- NCT06018636
- Acronym / sponsor ID
- DIGEST / Nutrition & Child Development
- Keywords
- Nutritional status, Malnutrition, Growth, Cognitive Development, Anthropometry, Agropastoral, remote, rural
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 832 participants (estimated)
- Lead sponsor
- Khyber Medical University PeshawarUniversity, hospital or other
- Collaborators
- University of Chester, University of Glasgow, University of Bern
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 30 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Children with any co-existent systemic diseases, confirmed from medical records.
- Children on continuous medications for any medical issue.
- Physically or mentally handicapped children
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Background: PubMed 12035858Ramakrishnan U. Prevalence of micronutrient malnutrition worldwide. Nutr Rev. 2002 May;60(5 Pt 2):S46-52. doi: 10.1301/00296640260130731.
- Background: PubMed 29132614Roth 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.
- Background: PubMed 29122800Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Muhammad Shahzad, PhD principal investigator
Khyber Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutrition and Growth, run by Khyber Medical University Peshawar at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Shahzad, PhD (00923459048796, shahzad.ibms@kmu.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of dietary intake/patterns on Child growth as assessed by body mass index (BMI) (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06018636, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.