Clinical trial NCT05934422: NiPPeR Randomised Trial - Child Follow Up Study
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
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: 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
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: National University Hospital, Singapore
name: Auckland UniServices Ltd.
name: Institute for Human Development and Potential (IHDP), Singapore
name: National University of Singapore
name: National University Health System, Singapore
name: University of Auckland, New Zealand
First posted: 2023-07-07
Enrollment: 510
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Child Body Mass Index (kg/m2), derived from weight and height
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Dimensional Change Card Sort Test (raw & T-scores)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Flanker Inhibitory Control & Attention Test (raw & T-scores)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Strengths & Difficulties Questionnaire score (no units)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child Behaviour Check List score (no units)
timeFrame: Up to age 8 years, from periconception to age 8 years
Secondary outcomes:
measure: Body fat mass (kg, % and indices)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Change in body fat mass (kg)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Body lean mass (kg, % and indices)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Change in lean mass (kg)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Body bone mass (kg, % and indices)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Change in bone mass (kg)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child height (cm)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Height growth (cm)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Change in body mass index (z-score & percentile)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Change in weight (kg)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child mid-upper arm circumference (cm)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Change in mid-upper circumference (z-score)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child waist circumference (cm)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Change in waist circumference (z-score)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Heart rate response to step test (beats per minute)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child blood pressure (mm Hg)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child resting heart rate (beats per minute)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child minutes to return to resting heart rate (minutes)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Diagnosed medical conditions or disorders ascertained by questionnaire, including child medical conditions, infections, gastrointestinal, cardiovascular, respiratory, dermatological, neuropsychological, mental and musculoskeletal health and wellbeing
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Dietary patterns ascertained by frequency questionnaires
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child Eating Behaviour Questionnaire
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Parental Feeding Practices Questionnaire
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Children's Sleep Habits Questionnaire
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Children's actigraphy measurements of activity behaviours [minutes/day]
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child Movement Behaviour Questionnaire
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Skin pricks test results to allergens [mm]
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Hair metabolome panel concentrations (pmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Urine micronutrient concentrations (nmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Blood micronutrient concentrations (nmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Blood trace element concentrations (pmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Urine trace element concentrations (pmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Stool metagenomic profile (abundance)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Skin metagenomic profile (abundance)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Stool metatranscriptomic profile (relative activity)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Skin metatranscriptomic profile (relative activity)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Stool metabolomic profile (pmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Skin metabolomic profile (pmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Blood molecular profile (% methylation)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Buccal molecular profile (% methylation)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Blood transcriptomic profile (relative expression)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Buccal transcriptomic profile (relative expression)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Genetic variation (DNA sequence analysis)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Circulating chemocytokine measurements (nmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Circulating adipokine measurements (nmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Circulating inflammatory marker measurement (nmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Plasma glucose concentration (mmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Plasma lipid concentrations (mmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Plasma high-sensitivity C-reactive protein concentrations (mmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Blood metabolome panel concentrations (pmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Urine metabolome panel concentrations (pmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Urine measurement of environmental pollutant exposure (pmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Blood measurement of environmental pollutant exposure (ng/gm lipid)
timeFrame: Up to age 8 years, from periconception to age 8 years
measure: Hair measurement of environmental pollutant exposure (pmol/L)
timeFrame: Up to age 8 years, from periconception to age 8 years
Other outcomes:
measure: Healthcare utilisation (US$)
timeFrame: Up to age 8 years, from periconception to age 8 years
Locations:
city: Auckland
country: New Zealand
facility: The University of Auckland
city: Singapore
country: Singapore
facility: National University Hospital
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
state: Hampshire
Study officials:
affiliation: The University of Auckland
name: Wayne S Cutfield, MB MD FRACP
role: PRINCIPAL_INVESTIGATOR
affiliation: National University of Singapore
name: Shiao-Yng Chan, MD PhD FRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: MRC Lifecourse Epidemiology Centre, University of Southampton
name: Keith M Godfrey, BM PhD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.