Trials / Completed
CompletedNCT05934422
NiPPeR Randomised Trial - Child Follow Up Study
Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health - Child Health and Well-being Follow Up Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 461 (actual)
- Sponsor
- University of Southampton · Academic / Other
- Sex
- All
- Age
- 6 Years – 8 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-06-16
- Primary completion
- 2025-08-14
- Completion
- 2025-08-14
- First posted
- 2023-07-07
- Last updated
- 2025-11-19
Locations
3 sites across 3 countries: New Zealand, Singapore, United Kingdom
Source: ClinicalTrials.gov record NCT05934422. Inclusion in this directory is not an endorsement.