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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
461
Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.
Control nutritional drink containing a standard mix of micronutrients
The University of Auckland
Auckland, New Zealand
National University Hospital
Singapore, Singapore
University Hospital Southampton
Southampton, Hampshire, United Kingdom
Child Body Mass Index (kg/m2), derived from weight and height
Child size and body composition
Time frame: Up to age 8 years, from periconception to age 8 years
Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ)
Child cognition
Time frame: Up to age 8 years, from periconception to age 8 years
Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance)
Child insulin resistance
Time frame: Up to age 8 years, from periconception to age 8 years
Dimensional Change Card Sort Test (raw & T-scores)
Child executive functioning - NIH Toolbox Cognition Battery component
Time frame: Up to age 8 years, from periconception to age 8 years
Flanker Inhibitory Control & Attention Test (raw & T-scores)
Child executive functioning - NIH Toolbox Cognition Battery Component
Time frame: Up to age 8 years, from periconception to age 8 years
Strengths & Difficulties Questionnaire score (no units)
Child neurobehavioural functioning
Time frame: Up to age 8 years, from periconception to age 8 years
Child Behaviour Check List score (no units)
Child neurobehavioural functioning
Time frame: Up to age 8 years, from periconception to age 8 years
Body fat mass (kg, % and indices)
Obesity and body composition
Time frame: Up to age 8 years, from periconception to age 8 years
Change in body fat mass (kg)
Adiposity gain
Time frame: Up to age 8 years, from periconception to age 8 years
Body lean mass (kg, % and indices)
Child body composition - lean mass
Time frame: Up to age 8 years, from periconception to age 8 years
Change in lean mass (kg)
Lean mass gain
Time frame: Up to age 8 years, from periconception to age 8 years
Body bone mass (kg, % and indices)
Child body composition - bone mass
Time frame: Up to age 8 years, from periconception to age 8 years
Change in bone mass (kg)
Bone mass gain
Time frame: Up to age 8 years, from periconception to age 8 years
Child height (cm)
Child height
Time frame: Up to age 8 years, from periconception to age 8 years
Height growth (cm)
Linear growth
Time frame: Up to age 8 years, from periconception to age 8 years
Change in body mass index (z-score & percentile)
Change in BMI
Time frame: Up to age 8 years, from periconception to age 8 years
Change in weight (kg)
Weight gain
Time frame: Up to age 8 years, from periconception to age 8 years
Child mid-upper arm circumference (cm)
Child arm circumference
Time frame: Up to age 8 years, from periconception to age 8 years
Change in mid-upper circumference (z-score)
Change in soft tissue mass
Time frame: Up to age 8 years, from periconception to age 8 years
Child waist circumference (cm)
Child waist circumference
Time frame: Up to age 8 years, from periconception to age 8 years
Change in waist circumference (z-score)
Adiposity gain
Time frame: Up to age 8 years, from periconception to age 8 years
Heart rate response to step test (beats per minute)
Cardiovascular fitness and function
Time frame: Up to age 8 years, from periconception to age 8 years
Child blood pressure (mm Hg)
Cardiovascular fitness and function
Time frame: Up to age 8 years, from periconception to age 8 years
Child resting heart rate (beats per minute)
Cardiovascular fitness and function
Time frame: Up to age 8 years, from periconception to age 8 years
Child minutes to return to resting heart rate (minutes)
Cardiovascular fitness and function
Time frame: Up to age 8 years, from periconception to age 8 years
Diagnosed medical conditions or disorders ascertained by questionnaire, including child medical conditions, infections, gastrointestinal, cardiovascular, respiratory, dermatological, neuropsychological, mental and musculoskeletal health and wellbeing
Child health and wellbeing
Time frame: Up to age 8 years, from periconception to age 8 years
Dietary patterns ascertained by frequency questionnaires
Child diet
Time frame: Up to age 8 years, from periconception to age 8 years
Child Eating Behaviour Questionnaire
Child eating behaviours
Time frame: Up to age 8 years, from periconception to age 8 years
Parental Feeding Practices Questionnaire
Parental feeding practices
Time frame: Up to age 8 years, from periconception to age 8 years
Children's Sleep Habits Questionnaire
Child sleep patterns
Time frame: Up to age 8 years, from periconception to age 8 years
Children's actigraphy measurements of activity behaviours [minutes/day]
Child physical activity, sleep and sedentary behaviours
Time frame: Up to age 8 years, from periconception to age 8 years
Child Movement Behaviour Questionnaire
Child activity behaviours
Time frame: Up to age 8 years, from periconception to age 8 years
Skin pricks test results to allergens [mm]
Child atopic sensitisation
Time frame: Up to age 8 years, from periconception to age 8 years
Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires
Child atopic and allergic wellbeing and disorders
Time frame: Up to age 8 years, from periconception to age 8 years
Hair metabolome panel concentrations (pmol/L)
Biomarkers of health and wellbeing measured in hair samples
Time frame: Up to age 8 years, from periconception to age 8 years
Urine micronutrient concentrations (nmol/L)
Child micronutrient status
Time frame: Up to age 8 years, from periconception to age 8 years
Blood micronutrient concentrations (nmol/L)
Child circulating micronutrient profile
Time frame: Up to age 8 years, from periconception to age 8 years
Blood trace element concentrations (pmol/L)
Child circulating trace element profile
Time frame: Up to age 8 years, from periconception to age 8 years
Urine trace element concentrations (pmol/L)
Child trace element status
Time frame: Up to age 8 years, from periconception to age 8 years
Stool metagenomic profile (abundance)
Child gut microbiota composition
Time frame: Up to age 8 years, from periconception to age 8 years
Skin metagenomic profile (abundance)
Child skin microbiota composition
Time frame: Up to age 8 years, from periconception to age 8 years
Stool metatranscriptomic profile (relative activity)
Child gut microbiota activity profile
Time frame: Up to age 8 years, from periconception to age 8 years
Skin metatranscriptomic profile (relative activity)
Child skin microbiota activity profile
Time frame: Up to age 8 years, from periconception to age 8 years
Stool metabolomic profile (pmol/L)
Child gut microbiota metabolite profile
Time frame: Up to age 8 years, from periconception to age 8 years
Skin metabolomic profile (pmol/L)
Child skin microbiota metabolite profile
Time frame: Up to age 8 years, from periconception to age 8 years
Blood molecular profile (% methylation)
Child blood epigenetic profile
Time frame: Up to age 8 years, from periconception to age 8 years
Buccal molecular profile (% methylation)
Child buccal cell epigenetic profile
Time frame: Up to age 8 years, from periconception to age 8 years
Blood transcriptomic profile (relative expression)
Child blood transcriptomic profile
Time frame: Up to age 8 years, from periconception to age 8 years
Buccal transcriptomic profile (relative expression)
Child buccal cell transcriptomic profile
Time frame: Up to age 8 years, from periconception to age 8 years
Genetic variation (DNA sequence analysis)
Genetic variant analysis
Time frame: Up to age 8 years, from periconception to age 8 years
Circulating chemocytokine measurements (nmol/L)
Child chemocytokine profile
Time frame: Up to age 8 years, from periconception to age 8 years
Circulating adipokine measurements (nmol/L)
Child adipokine profile
Time frame: Up to age 8 years, from periconception to age 8 years
Circulating inflammatory marker measurement (nmol/L)
Child inflammatory factor profile
Time frame: Up to age 8 years, from periconception to age 8 years
Plasma glucose concentration (mmol/L)
Child's plasma glycemia
Time frame: Up to age 8 years, from periconception to age 8 years
Plasma lipid concentrations (mmol/L)
Child's metabolic profile - lipid concentrations
Time frame: Up to age 8 years, from periconception to age 8 years
Plasma high-sensitivity C-reactive protein concentrations (mmol/L)
Child's inflammatory marker status
Time frame: Up to age 8 years, from periconception to age 8 years
Blood metabolome panel concentrations (pmol/L)
Child's blood metabolomic status
Time frame: Up to age 8 years, from periconception to age 8 years
Urine metabolome panel concentrations (pmol/L)
Child's urine metabolomic status
Time frame: Up to age 8 years, from periconception to age 8 years
Urine measurement of environmental pollutant exposure (pmol/L)
Urine exposome pollutant profile
Time frame: Up to age 8 years, from periconception to age 8 years
Blood measurement of environmental pollutant exposure (ng/gm lipid)
Blood exposome pollutant profile
Time frame: Up to age 8 years, from periconception to age 8 years
Hair measurement of environmental pollutant exposure (pmol/L)
Hair exposome pollutant profile
Time frame: Up to age 8 years, from periconception to age 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.