NiPPeR Randomised Trial - Child Follow Up Study

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

Interventions

OTHER

Intervention (Study Nutritional Drink)

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

OTHER

Control (Standard Nutritional Drink)

Control nutritional drink containing a standard mix of micronutrients

Sponsors & Collaborators

• National University Hospital, Singapore

  collaborator OTHER

• Auckland UniServices Ltd.

  collaborator INDUSTRY

• Institute for Human Development and Potential (IHDP), Singapore

  collaborator OTHER

• National University of Singapore

  collaborator OTHER

• National University Health System, Singapore

  collaborator OTHER

• University of Auckland, New Zealand

  collaborator OTHER

• University of Southampton

  lead OTHER

Principal Investigators

• Wayne S Cutfield, MB MD FRACP · The University of Auckland

• Shiao-Yng Chan, MD PhD FRCOG · National University of Singapore

• Keith M Godfrey, BM PhD FRCP · MRC Lifecourse Epidemiology Centre, University of Southampton

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

8 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-16

Primary Completion

2025-08-14

Completion

2025-08-14

Countries

• New Zealand
• Singapore
• United Kingdom

Study Locations