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Completed

NCT Number: NCT05934422

NiPPeR Randomised Trial - Child Follow Up Study

There is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms.

This study is a follow up of children from the NiPPeR trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. In this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms.

The data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.

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Key information

Conditions

Obesity, Childhood Allergy Atopic Dermatitis Atopy Behavior Body Weight Breast Feeding Breastfeeding Cognition Communicable Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Disease Attributes Feeding Behavior Genetic Diseases, Inborn Growth Disorders Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Lifestyle Metabolic Disturbance Microbial Colonization Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutrition Disorders Nutrition, Healthy Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

6 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Auckland, Auckland, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

All children still participating in the NiPPeR study at 6-8 years.

Exclusion criteria

Known significant congenital anomaly or genetic condition that influences child growth or neurodevelopment.

Treatment and study plan

Intervention (Study Nutritional Drink)

Other

Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.

Control (Standard Nutritional Drink)

Other

Control nutritional drink containing a standard mix of micronutrients

Primary outcomes

  1. Child Body Mass Index (kg/m2), derived from weight and height

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child size and body composition

  2. Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child cognition

  3. Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child insulin resistance

  4. Dimensional Change Card Sort Test (raw & T-scores)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child executive functioning - NIH Toolbox Cognition Battery component

  5. Flanker Inhibitory Control & Attention Test (raw & T-scores)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child executive functioning - NIH Toolbox Cognition Battery Component

  6. Strengths & Difficulties Questionnaire score (no units)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child neurobehavioural functioning

  7. Child Behaviour Check List score (no units)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child neurobehavioural functioning

Secondary outcomes

  1. Body fat mass (kg, % and indices)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Obesity and body composition

  2. Change in body fat mass (kg)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Adiposity gain

  3. Body lean mass (kg, % and indices)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child body composition - lean mass

  4. Change in lean mass (kg)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Lean mass gain

  5. Body bone mass (kg, % and indices)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child body composition - bone mass

  6. Change in bone mass (kg)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Bone mass gain

  7. Child height (cm)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child height

  8. Height growth (cm)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Linear growth

  9. Change in body mass index (z-score & percentile)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Change in BMI

  10. Change in weight (kg)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Weight gain

  11. Child mid-upper arm circumference (cm)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child arm circumference

  12. Change in mid-upper circumference (z-score)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Change in soft tissue mass

  13. Child waist circumference (cm)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child waist circumference

  14. Change in waist circumference (z-score)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Adiposity gain

  15. Heart rate response to step test (beats per minute)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Cardiovascular fitness and function

  16. Child blood pressure (mm Hg)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Cardiovascular fitness and function

  17. Child resting heart rate (beats per minute)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Cardiovascular fitness and function

  18. Child minutes to return to resting heart rate (minutes)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Cardiovascular fitness and function

  19. Diagnosed medical conditions or disorders ascertained by questionnaire, including child medical conditions, infections, gastrointestinal, cardiovascular, respiratory, dermatological, neuropsychological, mental and musculoskeletal health and wellbeing

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child health and wellbeing

  20. Dietary patterns ascertained by frequency questionnaires

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child diet

  21. Child Eating Behaviour Questionnaire

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child eating behaviours

  22. Parental Feeding Practices Questionnaire

    Time frame: Up to age 8 years, from periconception to age 8 years

    Parental feeding practices

  23. Children's Sleep Habits Questionnaire

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child sleep patterns

  24. Children's actigraphy measurements of activity behaviours [minutes/day]

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child physical activity, sleep and sedentary behaviours

  25. Child Movement Behaviour Questionnaire

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child activity behaviours

  26. Skin pricks test results to allergens [mm]

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child atopic sensitisation

  27. Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child atopic and allergic wellbeing and disorders

  28. Hair metabolome panel concentrations (pmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Biomarkers of health and wellbeing measured in hair samples

  29. Urine micronutrient concentrations (nmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child micronutrient status

  30. Blood micronutrient concentrations (nmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child circulating micronutrient profile

  31. Blood trace element concentrations (pmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child circulating trace element profile

  32. Urine trace element concentrations (pmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child trace element status

  33. Stool metagenomic profile (abundance)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child gut microbiota composition

  34. Skin metagenomic profile (abundance)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child skin microbiota composition

  35. Stool metatranscriptomic profile (relative activity)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child gut microbiota activity profile

  36. Skin metatranscriptomic profile (relative activity)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child skin microbiota activity profile

  37. Stool metabolomic profile (pmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child gut microbiota metabolite profile

  38. Skin metabolomic profile (pmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child skin microbiota metabolite profile

  39. Blood molecular profile (% methylation)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child blood epigenetic profile

  40. Buccal molecular profile (% methylation)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child buccal cell epigenetic profile

  41. Blood transcriptomic profile (relative expression)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child blood transcriptomic profile

  42. Buccal transcriptomic profile (relative expression)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child buccal cell transcriptomic profile

  43. Genetic variation (DNA sequence analysis)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Genetic variant analysis

  44. Circulating chemocytokine measurements (nmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child chemocytokine profile

  45. Circulating adipokine measurements (nmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child adipokine profile

  46. Circulating inflammatory marker measurement (nmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child inflammatory factor profile

  47. Plasma glucose concentration (mmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child's plasma glycemia

  48. Plasma lipid concentrations (mmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child's metabolic profile - lipid concentrations

  49. Plasma high-sensitivity C-reactive protein concentrations (mmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child's inflammatory marker status

  50. Blood metabolome panel concentrations (pmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child's blood metabolomic status

  51. Urine metabolome panel concentrations (pmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Child's urine metabolomic status

  52. Urine measurement of environmental pollutant exposure (pmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Urine exposome pollutant profile

  53. Blood measurement of environmental pollutant exposure (ng/gm lipid)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Blood exposome pollutant profile

  54. Hair measurement of environmental pollutant exposure (pmol/L)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Hair exposome pollutant profile

Other outcomes

  1. Healthcare utilisation (US$)

    Time frame: Up to age 8 years, from periconception to age 8 years

    Health economics analysis of child outcomes

Sponsors and collaborators

Lead sponsor

University of Southampton

Other

Collaborators

  • Auckland UniServices Ltd.
  • Institute for Human Development and Potential (IHDP), Singapore
  • National University Health System, Singapore
  • National University Hospital, Singapore
  • National University of Singapore
  • University of Auckland, New Zealand

Registry information

Official study title

Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health - Child Health and Well-being Follow Up Study

Acronym: NiPPeR Child

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 7, 2023
Registry last updated
Nov 19, 2025

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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