NiPPeR Randomised Trial - Child Follow Up Study

Atopic Dermatitis Clinical Trial

— 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05934422
• Other study ID #: 79093
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 16, 2023
• Est. completion date: August 30, 2026

Study information

• Verified date: June 2023
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 510
• Est. completion date: August 30, 2026
• Est. primary completion date: August 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergy
• Atopic Dermatitis
• Atopy
• Breastfeeding
• Cognition
• Communicable Diseases
• Dermatitis
• Growth Disorders
• Infections
• Lifestyle
• Metabolic Disturbance
• Microbial Colonization
• Neurobehavioral Manifestations
• Obesity, Childhood
• Pediatric Obesity

Intervention

Other:
• Intervention (Study Nutritional Drink)
Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.
• Control (Standard Nutritional Drink)
Control nutritional drink containing a standard mix of micronutrients

Locations

Country	Name	City	State
New Zealand	The University of Auckland	Auckland
Singapore	National University Hospital	Singapore
United Kingdom	University Hospital Southampton	Southampton	Hampshire

Sponsors (7)

Lead Sponsor	Collaborator
University of Southampton	Auckland UniServices Ltd., National University Health System, Singapore, National University Hospital, Singapore, National University of Singapore, Singapore Institute for Clinical Sciences, University of Auckland, New Zealand

Countries where clinical trial is conducted

New Zealand,  Singapore,  United Kingdom, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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