NiPPeR Child: NiPPeR Randomised Trial - Child Follow Up Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prior Intervention - enhanced micronutrients, probiotics, myo-inositol in preconception & pregnancy NiPPeR Study intervention drink containing a mix of micronutrients, probiotics and myo-inositol given to the mother during preconception & pregnancy |
Other: Intervention (Study Nutritional Drink)
Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.
|
| Active Comparator: Prior Control - standard micronutrients in preconception & pregnancy NiPPeR Study control nutritional drink containing a mix of micronutrients given to the mother during preconception & pregnancy |
Other: Control (Standard Nutritional Drink)
Control nutritional drink containing a standard mix of micronutrients
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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
- Strengths & Difficulties Questionnaire score (no units) [Up to age 8 years, from periconception to age 8 years]
Child neurobehavioural functioning
- Child Behaviour Check List score (no units) [Up to age 8 years, from periconception to age 8 years]
Child neurobehavioural functioning
Secondary Outcome Measures
- Body fat mass (kg, % and indices) [Up to age 8 years, from periconception to age 8 years]
Obesity and body composition
- Change in body fat mass (kg) [Up to age 8 years, from periconception to age 8 years]
Adiposity 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 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
- Change in bone mass (kg) [Up to age 8 years, from periconception to age 8 years]
Bone mass gain
- Child height (cm) [Up to age 8 years, from periconception to age 8 years]
Child height
- Height growth (cm) [Up to age 8 years, from periconception to age 8 years]
Linear growth
- Change in body mass index (z-score & percentile) [Up to age 8 years, from periconception to age 8 years]
Change in BMI
- Change in weight (kg) [Up to age 8 years, from periconception to age 8 years]
Weight gain
- Child mid-upper arm circumference (cm) [Up to age 8 years, from periconception to age 8 years]
Child arm circumference
- Change in mid-upper circumference (z-score) [Up to age 8 years, from periconception to age 8 years]
Change in soft tissue mass
- Child waist circumference (cm) [Up to age 8 years, from periconception to age 8 years]
Child waist 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
- 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 minutes to return to resting heart rate (minutes) [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
- Dietary patterns ascertained by frequency questionnaires [Up to age 8 years, from periconception to age 8 years]
Child diet
- Child Eating Behaviour Questionnaire [Up to age 8 years, from periconception to age 8 years]
Child eating behaviours
- Parental Feeding Practices Questionnaire [Up to age 8 years, from periconception to age 8 years]
Parental feeding practices
- 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
- Child Movement Behaviour Questionnaire [Up to age 8 years, from periconception to age 8 years]
Child activity behaviours
- Skin pricks test results to allergens [mm] [Up to age 8 years, from periconception to age 8 years]
Child atopic sensitisation
- 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
- 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
- Urine micronutrient concentrations (nmol/L) [Up to age 8 years, from periconception to age 8 years]
Child micronutrient status
- Blood micronutrient concentrations (nmol/L) [Up to age 8 years, from periconception to age 8 years]
Child circulating micronutrient profile
- Blood trace element concentrations (pmol/L) [Up to age 8 years, from periconception to age 8 years]
Child circulating trace element profile
- Urine trace element concentrations (pmol/L) [Up to age 8 years, from periconception to age 8 years]
Child trace element status
- 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
- 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
- Stool metabolomic profile (pmol/L) [Up to age 8 years, from periconception to age 8 years]
Child gut microbiota metabolite profile
- Skin metabolomic profile (pmol/L) [Up to age 8 years, from periconception to age 8 years]
Child skin microbiota metabolite profile
- Blood molecular profile (% methylation) [Up to age 8 years, from periconception to age 8 years]
Child blood epigenetic 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
- Buccal transcriptomic profile (relative expression) [Up to age 8 years, from periconception to age 8 years]
Child buccal cell transcriptomic profile
- Genetic variation (DNA sequence analysis) [Up to age 8 years, from periconception to age 8 years]
Genetic variant analysis
- Circulating chemocytokine measurements (nmol/L) [Up to age 8 years, from periconception to age 8 years]
Child chemocytokine profile
- 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
- Plasma glucose concentration (mmol/L) [Up to age 8 years, from periconception to age 8 years]
Child's plasma glycemia
- Plasma lipid concentrations (mmol/L) [Up to age 8 years, from periconception to age 8 years]
Child's metabolic profile - lipid concentrations
- 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
- Blood metabolome panel concentrations (pmol/L) [Up to age 8 years, from periconception to age 8 years]
Child's blood metabolomic status
- 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
- Blood measurement of environmental pollutant exposure (ng/gm lipid) [Up to age 8 years, from periconception to age 8 years]
Blood 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
Other Outcome Measures
- Healthcare utilisation (US$) [Up to age 8 years, from periconception to age 8 years]
Health economics analysis of child outcomes
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Auckland | Auckland | New Zealand | 1142 | |
| 2 | National University Hospital | Singapore | Singapore | 119228 | |
| 3 | University Hospital Southampton | Southampton | Hampshire | United Kingdom | SO16 6YD |
Sponsors and Collaborators
- University of Southampton
- National University Hospital, Singapore
- Auckland UniServices Ltd.
- Singapore Institute for Clinical Sciences
- National University of Singapore
- National University Health System, Singapore
- University of Auckland, New Zealand
Investigators
- Principal Investigator: Wayne S Cutfield, MB MD FRACP, The University of Auckland
- Principal Investigator: Shiao-Yng Chan, MD PhD FRCOG, National University of Singapore
- Principal Investigator: Keith M Godfrey, BM PhD FRCP, MRC Lifecourse Epidemiology Centre, University of Southampton
Study Documents (Full-Text)
None provided.More Information
Publications
- Godfrey KM, Barton SJ, El-Heis S, Kenealy T, Nield H, Baker PN, Chong YS, Cutfield W, Chan SY; NiPPeR Study Group. Myo-Inositol, Probiotics, and Micronutrient Supplementation From Preconception for Glycemia in Pregnancy: NiPPeR International Multicenter Double-Blind Randomized Controlled Trial. Diabetes Care. 2021 May;44(5):1091-1099. doi: 10.2337/dc20-2515. Epub 2021 Mar 29.
- Godfrey KM, Cutfield W, Chan SY, Baker PN, Chong YS; NiPPeR Study Group. Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health ("NiPPeR"): study protocol for a randomised controlled trial. Trials. 2017 Mar 20;18(1):131. doi: 10.1186/s13063-017-1875-x.
- 79093