NiPPeR Randomised Trial - Child Follow Up Study

NCT05934422 | Completed

• 1 other identifier: 79093
• Study Type: interventional
• Target: 461
• Locations: 3 countries
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• 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

• 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

• 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

• Strengths & Difficulties Questionnaire score (no units)

  Child neurobehavioural functioning

  Up to age 8 years, from periconception to age 8 years

• Child Behaviour Check List score (no units)

  Child neurobehavioural functioning

  Up to age 8 years, from periconception to age 8 years

Secondary Outcomes (54)

• Body fat mass (kg, % and indices)

  Up to age 8 years, from periconception to age 8 years

• Change in body fat mass (kg)

  Up to age 8 years, from periconception to age 8 years

• Body lean mass (kg, % and indices)

  Up to age 8 years, from periconception to age 8 years

• Change in lean mass (kg)

  Up to age 8 years, from periconception to age 8 years

• Body bone mass (kg, % and indices)

  Up to age 8 years, from periconception to age 8 years

Other Outcomes (1)

• Healthcare utilisation (US$)

  Up to age 8 years, from periconception to age 8 years

Study Arms (2)

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

EXPERIMENTAL

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)

Prior Control - standard micronutrients in preconception & pregnancy

ACTIVE COMPARATOR

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

Other: Control (Standard Nutritional Drink)

Interventions

Intervention (Study Nutritional Drink) OTHER

Study nutritional drink containing a mix of enriched micronutrients, probiotics and myo-inositol.

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

Control (Standard Nutritional Drink) OTHER

Control nutritional drink containing a standard mix of micronutrients

Prior Control - standard micronutrients in preconception & pregnancy

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• All children still participating in the NiPPeR study at 6-8 years.

You may not qualify if:

• Known significant congenital anomaly or genetic condition that influences child growth or neurodevelopment.

Sponsors & Collaborators

• University of Southampton: lead
• National University Hospital, Singapore: collaborator
• Auckland UniServices Ltd.: collaborator
• Institute for Human Development and Potential (IHDP), Singapore: collaborator
• National University of Singapore: collaborator
• National University Health System, Singapore: collaborator
• University of Auckland, New Zealand: collaborator

Study Sites (3)

The University of Auckland

Auckland, 1142, New Zealand

Location

National University Hospital

Singapore, 119228, Singapore

Location

University Hospital Southampton

Southampton, Hampshire, SO16 6YD, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 28320484 BACKGROUND

• 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.

  PMID: 33782086 BACKGROUND

MeSH Terms

Conditions

Pediatric Obesity; Neurobehavioral Manifestations; Growth Disorders; Hypersensitivity; Dermatitis, Atopic; Communicable Diseases; Breast Feeding

Interventions

Methods

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Infections; Disease Attributes; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: July 7, 2023
• Study Start: June 16, 2023
• Primary Completion: August 14, 2025
• Study Completion: August 14, 2025
• Last Updated: November 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); NZ (1); SG (1)