NiPPeR Randomised Trial - Child Follow Up Study
- Conditions
- CognitionAtopic DermatitisLifestyleMicrobial ColonizationAllergyNeurobehavioral ManifestationsMetabolic DisturbanceNutrition, HealthyBreastfeedingGrowth Disorders
- Interventions
- Other: Intervention (Study Nutritional Drink)Other: Control (Standard Nutritional Drink)
- Registration Number
- NCT05934422
- Lead Sponsor
- University of Southampton
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 510
All children still participating in the NiPPeR study at 6-8 years.
Known significant congenital anomaly or genetic condition that influences child growth or neurodevelopment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prior Intervention - enhanced micronutrients, probiotics, myo-inositol in preconception & pregnancy Intervention (Study Nutritional Drink) NiPPeR Study intervention drink containing a mix of micronutrients, probiotics and myo-inositol given to the mother during preconception \& pregnancy Prior Control - standard micronutrients in preconception & pregnancy Control (Standard Nutritional Drink) NiPPeR Study control nutritional drink containing a mix of micronutrients given to the mother during preconception \& pregnancy
- Primary Outcome Measures
Name Time Method Child Body Mass Index (kg/m2), derived from weight and height Up to age 8 years, from periconception to age 8 years Child size and body composition
Strengths & Difficulties Questionnaire score (no units) Up to age 8 years, from periconception to age 8 years Child neurobehavioural functioning
Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ) Up to age 8 years, from periconception to age 8 years Child cognition
Dimensional Change Card Sort Test (raw & T-scores) Up to age 8 years, from periconception to age 8 years Child executive functioning - NIH Toolbox Cognition Battery component
Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance) Up to age 8 years, from periconception to age 8 years Child insulin resistance
Flanker Inhibitory Control & Attention Test (raw & T-scores) Up to age 8 years, from periconception to age 8 years Child executive functioning - NIH Toolbox Cognition Battery Component
Child Behaviour Check List score (no units) Up to age 8 years, from periconception to age 8 years Child neurobehavioural functioning
- Secondary Outcome Measures
Name Time Method Change in lean mass (kg) Up to age 8 years, from periconception to age 8 years Lean mass gain
Body bone mass (kg, % and indices) Up to age 8 years, from periconception to age 8 years Child body composition - bone mass
Child height (cm) Up to age 8 years, from periconception to age 8 years Child height
Change in weight (kg) Up to age 8 years, from periconception to age 8 years Weight gain
Body lean mass (kg, % and indices) Up to age 8 years, from periconception to age 8 years Child body composition - lean mass
Change in body mass index (z-score & percentile) Up to age 8 years, from periconception to age 8 years Change in BMI
Child mid-upper arm circumference (cm) Up to age 8 years, from periconception to age 8 years Child arm circumference
Change in waist circumference (z-score) Up to age 8 years, from periconception to age 8 years Adiposity gain
Heart rate response to step test (beats per minute) Up to age 8 years, from periconception to age 8 years Cardiovascular fitness and function
Diagnosed medical conditions or disorders ascertained by questionnaire, including child medical conditions, infections, gastrointestinal, cardiovascular, respiratory, dermatological, neuropsychological, mental and musculoskeletal health and wellbeing Up to age 8 years, from periconception to age 8 years Child health and wellbeing
Parental Feeding Practices Questionnaire Up to age 8 years, from periconception to age 8 years Parental feeding practices
Hair metabolome panel concentrations (pmol/L) Up to age 8 years, from periconception to age 8 years Biomarkers of health and wellbeing measured in hair samples
Body fat mass (kg, % and indices) Up to age 8 years, from periconception to age 8 years Obesity and body composition
Change in mid-upper circumference (z-score) Up to age 8 years, from periconception to age 8 years Change in soft tissue mass
Child blood pressure (mm Hg) Up to age 8 years, from periconception to age 8 years Cardiovascular fitness and function
Child resting heart rate (beats per minute) Up to age 8 years, from periconception to age 8 years Cardiovascular fitness and function
Child Eating Behaviour Questionnaire Up to age 8 years, from periconception to age 8 years Child eating behaviours
Children's Sleep Habits Questionnaire Up to age 8 years, from periconception to age 8 years Child sleep patterns
Children's actigraphy measurements of activity behaviours [minutes/day] Up to age 8 years, from periconception to age 8 years Child physical activity, sleep and sedentary behaviours
Skin pricks test results to allergens [mm] Up to age 8 years, from periconception to age 8 years Child atopic sensitisation
Change in body fat mass (kg) Up to age 8 years, from periconception to age 8 years Adiposity gain
Change in bone mass (kg) Up to age 8 years, from periconception to age 8 years Bone mass gain
Height growth (cm) Up to age 8 years, from periconception to age 8 years Linear growth
Child minutes to return to resting heart rate (minutes) Up to age 8 years, from periconception to age 8 years Cardiovascular fitness and function
Stool metagenomic profile (abundance) Up to age 8 years, from periconception to age 8 years Child gut microbiota composition
Skin metagenomic profile (abundance) Up to age 8 years, from periconception to age 8 years Child skin microbiota composition
Buccal transcriptomic profile (relative expression) Up to age 8 years, from periconception to age 8 years Child buccal cell transcriptomic profile
Plasma high-sensitivity C-reactive protein concentrations (mmol/L) Up to age 8 years, from periconception to age 8 years Child's inflammatory marker status
Child waist circumference (cm) Up to age 8 years, from periconception to age 8 years Child waist circumference
Dietary patterns ascertained by frequency questionnaires Up to age 8 years, from periconception to age 8 years Child diet
Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires Up to age 8 years, from periconception to age 8 years Child atopic and allergic wellbeing and disorders
Urine micronutrient concentrations (nmol/L) Up to age 8 years, from periconception to age 8 years Child micronutrient status
Blood trace element concentrations (pmol/L) Up to age 8 years, from periconception to age 8 years Child circulating trace element profile
Blood molecular profile (% methylation) Up to age 8 years, from periconception to age 8 years Child blood epigenetic profile
Plasma glucose concentration (mmol/L) Up to age 8 years, from periconception to age 8 years Child's plasma glycemia
Blood metabolome panel concentrations (pmol/L) Up to age 8 years, from periconception to age 8 years Child's blood metabolomic status
Child Movement Behaviour Questionnaire Up to age 8 years, from periconception to age 8 years Child activity behaviours
Urine trace element concentrations (pmol/L) Up to age 8 years, from periconception to age 8 years Child trace element status
Genetic variation (DNA sequence analysis) Up to age 8 years, from periconception to age 8 years Genetic variant analysis
Circulating adipokine measurements (nmol/L) Up to age 8 years, from periconception to age 8 years Child adipokine profile
Circulating inflammatory marker measurement (nmol/L) Up to age 8 years, from periconception to age 8 years Child inflammatory factor profile
Urine metabolome panel concentrations (pmol/L) Up to age 8 years, from periconception to age 8 years Child's urine metabolomic status
Urine measurement of environmental pollutant exposure (pmol/L) Up to age 8 years, from periconception to age 8 years Urine exposome pollutant profile
Hair measurement of environmental pollutant exposure (pmol/L) Up to age 8 years, from periconception to age 8 years Hair exposome pollutant profile
Blood micronutrient concentrations (nmol/L) Up to age 8 years, from periconception to age 8 years Child circulating micronutrient profile
Stool metatranscriptomic profile (relative activity) Up to age 8 years, from periconception to age 8 years Child gut microbiota activity profile
Skin metatranscriptomic profile (relative activity) Up to age 8 years, from periconception to age 8 years Child skin microbiota activity profile
Skin metabolomic profile (pmol/L) Up to age 8 years, from periconception to age 8 years Child skin microbiota metabolite profile
Buccal molecular profile (% methylation) Up to age 8 years, from periconception to age 8 years Child buccal cell epigenetic profile
Blood transcriptomic profile (relative expression) Up to age 8 years, from periconception to age 8 years Child blood transcriptomic profile
Plasma lipid concentrations (mmol/L) Up to age 8 years, from periconception to age 8 years Child's metabolic profile - lipid concentrations
Blood measurement of environmental pollutant exposure (ng/gm lipid) Up to age 8 years, from periconception to age 8 years Blood exposome pollutant profile
Stool metabolomic profile (pmol/L) Up to age 8 years, from periconception to age 8 years Child gut microbiota metabolite profile
Circulating chemocytokine measurements (nmol/L) Up to age 8 years, from periconception to age 8 years Child chemocytokine profile
Trial Locations
- Locations (3)
University Hospital Southampton
🇬🇧Southampton, Hampshire, United Kingdom
The University of Auckland
🇳🇿Auckland, New Zealand
National University Hospital
🇸🇬Singapore, Singapore