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

University of Southampton

Status: Completed

Conditions: Growth Disorders; Atopy; Microbial Colonization; Obesity, Childhood; Cognition; Nutrition, Healthy; Neurobehavioral Manifestations; Allergy; Atopic Dermatitis; Lifestyle; Breastfeeding; Metabolic Disturbance

Treatments: Other: Control (Standard Nutritional Drink); Other: Intervention (Study Nutritional Drink)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05934422

79093

Details and patient eligibility

About

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.

Enrollment: 461 patients

Sex: All

Ages: 6 to 8 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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461 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Other: Intervention (Study Nutritional Drink)

Prior Control - standard micronutrients in preconception & pregnancy

Active Comparator group

Description:

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

Treatment:

Other: Control (Standard Nutritional Drink)