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NiPPeR Randomised Trial - Child Follow Up Study (NiPPeR Child)

Primary Purpose

Obesity, Childhood, Cognition, Neurobehavioral Manifestations

Status
Enrolling by invitation
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Intervention (Study Nutritional Drink)
Control (Standard Nutritional Drink)
Sponsored by
University of Southampton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood focused on measuring Nutrition, Body composition, Neurodevelopment, Lifestyle, Endocrinology and metabolism, Preconception, Supplementation, Pregnancy, Infancy, Breast milk

Eligibility Criteria

6 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The University of Auckland
  • National University Hospital
  • University Hospital Southampton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prior Intervention - enhanced micronutrients, probiotics, myo-inositol in preconception & pregnancy

Prior Control - standard micronutrients in preconception & pregnancy

Arm Description

NiPPeR Study intervention drink containing a mix of micronutrients, probiotics and myo-inositol given to the mother during preconception & pregnancy

NiPPeR Study control nutritional drink containing a mix of micronutrients given to the mother during preconception & pregnancy

Outcomes

Primary Outcome Measures

Child Body Mass Index (kg/m2), derived from weight and height
Child size and body composition
Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ)
Child cognition
Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance)
Child insulin resistance
Dimensional Change Card Sort Test (raw & T-scores)
Child executive functioning - NIH Toolbox Cognition Battery component
Flanker Inhibitory Control & Attention Test (raw & T-scores)
Child executive functioning - NIH Toolbox Cognition Battery Component
Strengths & Difficulties Questionnaire score (no units)
Child neurobehavioural functioning
Child Behaviour Check List score (no units)
Child neurobehavioural functioning

Secondary Outcome Measures

Body fat mass (kg, % and indices)
Obesity and body composition
Change in body fat mass (kg)
Adiposity gain
Body lean mass (kg, % and indices)
Child body composition - lean mass
Change in lean mass (kg)
Lean mass gain
Body bone mass (kg, % and indices)
Child body composition - bone mass
Change in bone mass (kg)
Bone mass gain
Child height (cm)
Child height
Height growth (cm)
Linear growth
Change in body mass index (z-score & percentile)
Change in BMI
Change in weight (kg)
Weight gain
Child mid-upper arm circumference (cm)
Child arm circumference
Change in mid-upper circumference (z-score)
Change in soft tissue mass
Child waist circumference (cm)
Child waist circumference
Change in waist circumference (z-score)
Adiposity gain
Heart rate response to step test (beats per minute)
Cardiovascular fitness and function
Child blood pressure (mm Hg)
Cardiovascular fitness and function
Child resting heart rate (beats per minute)
Cardiovascular fitness and function
Child minutes to return to resting heart rate (minutes)
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
Child health and wellbeing
Dietary patterns ascertained by frequency questionnaires
Child diet
Child Eating Behaviour Questionnaire
Child eating behaviours
Parental Feeding Practices Questionnaire
Parental feeding practices
Children's Sleep Habits Questionnaire
Child sleep patterns
Children's actigraphy measurements of activity behaviours [minutes/day]
Child physical activity, sleep and sedentary behaviours
Child Movement Behaviour Questionnaire
Child activity behaviours
Skin pricks test results to allergens [mm]
Child atopic sensitisation
Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires
Child atopic and allergic wellbeing and disorders
Hair metabolome panel concentrations (pmol/L)
Biomarkers of health and wellbeing measured in hair samples
Urine micronutrient concentrations (nmol/L)
Child micronutrient status
Blood micronutrient concentrations (nmol/L)
Child circulating micronutrient profile
Blood trace element concentrations (pmol/L)
Child circulating trace element profile
Urine trace element concentrations (pmol/L)
Child trace element status
Stool metagenomic profile (abundance)
Child gut microbiota composition
Skin metagenomic profile (abundance)
Child skin microbiota composition
Stool metatranscriptomic profile (relative activity)
Child gut microbiota activity profile
Skin metatranscriptomic profile (relative activity)
Child skin microbiota activity profile
Stool metabolomic profile (pmol/L)
Child gut microbiota metabolite profile
Skin metabolomic profile (pmol/L)
Child skin microbiota metabolite profile
Blood molecular profile (% methylation)
Child blood epigenetic profile
Buccal molecular profile (% methylation)
Child buccal cell epigenetic profile
Blood transcriptomic profile (relative expression)
Child blood transcriptomic profile
Buccal transcriptomic profile (relative expression)
Child buccal cell transcriptomic profile
Genetic variation (DNA sequence analysis)
Genetic variant analysis
Circulating chemocytokine measurements (nmol/L)
Child chemocytokine profile
Circulating adipokine measurements (nmol/L)
Child adipokine profile
Circulating inflammatory marker measurement (nmol/L)
Child inflammatory factor profile
Plasma glucose concentration (mmol/L)
Child's plasma glycemia
Plasma lipid concentrations (mmol/L)
Child's metabolic profile - lipid concentrations
Plasma high-sensitivity C-reactive protein concentrations (mmol/L)
Child's inflammatory marker status
Blood metabolome panel concentrations (pmol/L)
Child's blood metabolomic status
Urine metabolome panel concentrations (pmol/L)
Child's urine metabolomic status
Urine measurement of environmental pollutant exposure (pmol/L)
Urine exposome pollutant profile
Blood measurement of environmental pollutant exposure (ng/gm lipid)
Blood exposome pollutant profile
Hair measurement of environmental pollutant exposure (pmol/L)
Hair exposome pollutant profile

Full Information

First Posted
May 4, 2023
Last Updated
June 27, 2023
Sponsor
University of Southampton
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT05934422
Brief Title
NiPPeR Randomised Trial - Child Follow Up Study
Acronym
NiPPeR Child
Official Title
Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health - Child Health and Well-being Follow Up Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
August 30, 2026 (Anticipated)
Study Completion Date
August 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southampton
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Cognition, Neurobehavioral Manifestations, Metabolic Disturbance, Growth Disorders, Allergy, Atopic Dermatitis, Atopy, Nutrition, Healthy, Lifestyle, Microbial Colonization, Breastfeeding
Keywords
Nutrition, Body composition, Neurodevelopment, Lifestyle, Endocrinology and metabolism, Preconception, Supplementation, Pregnancy, Infancy, Breast milk

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
510 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prior Intervention - enhanced micronutrients, probiotics, myo-inositol in preconception & pregnancy
Arm Type
Experimental
Arm Description
NiPPeR Study intervention drink containing a mix of micronutrients, probiotics and myo-inositol given to the mother during preconception & pregnancy
Arm Title
Prior Control - standard micronutrients in preconception & pregnancy
Arm Type
Active Comparator
Arm Description
NiPPeR Study control nutritional drink containing a mix of micronutrients given to the mother during preconception & pregnancy
Intervention Type
Other
Intervention Name(s)
Intervention (Study Nutritional Drink)
Intervention Description
Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.
Intervention Type
Other
Intervention Name(s)
Control (Standard Nutritional Drink)
Intervention Description
Control nutritional drink containing a standard mix of micronutrients
Primary Outcome Measure Information:
Title
Child Body Mass Index (kg/m2), derived from weight and height
Description
Child size and body composition
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ)
Description
Child cognition
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance)
Description
Child insulin resistance
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Dimensional Change Card Sort Test (raw & T-scores)
Description
Child executive functioning - NIH Toolbox Cognition Battery component
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Flanker Inhibitory Control & Attention Test (raw & T-scores)
Description
Child executive functioning - NIH Toolbox Cognition Battery Component
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Strengths & Difficulties Questionnaire score (no units)
Description
Child neurobehavioural functioning
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child Behaviour Check List score (no units)
Description
Child neurobehavioural functioning
Time Frame
Up to age 8 years, from periconception to age 8 years
Secondary Outcome Measure Information:
Title
Body fat mass (kg, % and indices)
Description
Obesity and body composition
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Change in body fat mass (kg)
Description
Adiposity gain
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Body lean mass (kg, % and indices)
Description
Child body composition - lean mass
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Change in lean mass (kg)
Description
Lean mass gain
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Body bone mass (kg, % and indices)
Description
Child body composition - bone mass
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Change in bone mass (kg)
Description
Bone mass gain
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child height (cm)
Description
Child height
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Height growth (cm)
Description
Linear growth
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Change in body mass index (z-score & percentile)
Description
Change in BMI
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Change in weight (kg)
Description
Weight gain
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child mid-upper arm circumference (cm)
Description
Child arm circumference
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Change in mid-upper circumference (z-score)
Description
Change in soft tissue mass
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child waist circumference (cm)
Description
Child waist circumference
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Change in waist circumference (z-score)
Description
Adiposity gain
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Heart rate response to step test (beats per minute)
Description
Cardiovascular fitness and function
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child blood pressure (mm Hg)
Description
Cardiovascular fitness and function
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child resting heart rate (beats per minute)
Description
Cardiovascular fitness and function
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child minutes to return to resting heart rate (minutes)
Description
Cardiovascular fitness and function
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Diagnosed medical conditions or disorders ascertained by questionnaire, including child medical conditions, infections, gastrointestinal, cardiovascular, respiratory, dermatological, neuropsychological, mental and musculoskeletal health and wellbeing
Description
Child health and wellbeing
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Dietary patterns ascertained by frequency questionnaires
Description
Child diet
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child Eating Behaviour Questionnaire
Description
Child eating behaviours
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Parental Feeding Practices Questionnaire
Description
Parental feeding practices
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Children's Sleep Habits Questionnaire
Description
Child sleep patterns
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Children's actigraphy measurements of activity behaviours [minutes/day]
Description
Child physical activity, sleep and sedentary behaviours
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child Movement Behaviour Questionnaire
Description
Child activity behaviours
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Skin pricks test results to allergens [mm]
Description
Child atopic sensitisation
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires
Description
Child atopic and allergic wellbeing and disorders
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Hair metabolome panel concentrations (pmol/L)
Description
Biomarkers of health and wellbeing measured in hair samples
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Urine micronutrient concentrations (nmol/L)
Description
Child micronutrient status
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Blood micronutrient concentrations (nmol/L)
Description
Child circulating micronutrient profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Blood trace element concentrations (pmol/L)
Description
Child circulating trace element profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Urine trace element concentrations (pmol/L)
Description
Child trace element status
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Stool metagenomic profile (abundance)
Description
Child gut microbiota composition
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Skin metagenomic profile (abundance)
Description
Child skin microbiota composition
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Stool metatranscriptomic profile (relative activity)
Description
Child gut microbiota activity profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Skin metatranscriptomic profile (relative activity)
Description
Child skin microbiota activity profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Stool metabolomic profile (pmol/L)
Description
Child gut microbiota metabolite profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Skin metabolomic profile (pmol/L)
Description
Child skin microbiota metabolite profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Blood molecular profile (% methylation)
Description
Child blood epigenetic profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Buccal molecular profile (% methylation)
Description
Child buccal cell epigenetic profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Blood transcriptomic profile (relative expression)
Description
Child blood transcriptomic profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Buccal transcriptomic profile (relative expression)
Description
Child buccal cell transcriptomic profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Genetic variation (DNA sequence analysis)
Description
Genetic variant analysis
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Circulating chemocytokine measurements (nmol/L)
Description
Child chemocytokine profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Circulating adipokine measurements (nmol/L)
Description
Child adipokine profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Circulating inflammatory marker measurement (nmol/L)
Description
Child inflammatory factor profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Plasma glucose concentration (mmol/L)
Description
Child's plasma glycemia
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Plasma lipid concentrations (mmol/L)
Description
Child's metabolic profile - lipid concentrations
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Plasma high-sensitivity C-reactive protein concentrations (mmol/L)
Description
Child's inflammatory marker status
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Blood metabolome panel concentrations (pmol/L)
Description
Child's blood metabolomic status
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Urine metabolome panel concentrations (pmol/L)
Description
Child's urine metabolomic status
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Urine measurement of environmental pollutant exposure (pmol/L)
Description
Urine exposome pollutant profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Blood measurement of environmental pollutant exposure (ng/gm lipid)
Description
Blood exposome pollutant profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Title
Hair measurement of environmental pollutant exposure (pmol/L)
Description
Hair exposome pollutant profile
Time Frame
Up to age 8 years, from periconception to age 8 years
Other Pre-specified Outcome Measures:
Title
Healthcare utilisation (US$)
Description
Health economics analysis of child outcomes
Time Frame
Up to age 8 years, from periconception to age 8 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wayne S Cutfield, MB MD FRACP
Organizational Affiliation
The University of Auckland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shiao-Yng Chan, MD PhD FRCOG
Organizational Affiliation
National University of Singapore
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith M Godfrey, BM PhD FRCP
Organizational Affiliation
MRC Lifecourse Epidemiology Centre, University of Southampton
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Auckland
City
Auckland
ZIP/Postal Code
1142
Country
New Zealand
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
University Hospital Southampton
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28320484
Citation
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.
Results Reference
background
PubMed Identifier
33782086
Citation
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.
Results Reference
background

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NiPPeR Randomised Trial - Child Follow Up Study

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