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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05934422




Registration number
NCT05934422
Ethics application status
Date submitted
4/05/2023
Date registered
7/07/2023
Date last updated
7/07/2023

Titles & IDs
Public title
NiPPeR Randomised Trial - Child Follow Up Study
Scientific title
Nutritional Intervention Preconception and During Pregnancy to Maintain Healthy Glucose Metabolism and Offspring Health - Child Health and Well-being Follow Up Study
Secondary ID [1] 0 0
79093
Universal Trial Number (UTN)
Trial acronym
NiPPeR Child
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity, Childhood 0 0
Cognition 0 0
Neurobehavioral Manifestations 0 0
Metabolic Disturbance 0 0
Growth Disorders 0 0
Allergy 0 0
Atopic Dermatitis 0 0
Atopy 0 0
Nutrition, Healthy 0 0
Lifestyle 0 0
Microbial Colonization 0 0
Breastfeeding 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Sexually transmitted infections
Neurological 0 0 0 0
Other neurological disorders
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions
Diet and Nutrition 0 0 0 0
Obesity
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Intervention (Study Nutritional Drink)
Other interventions - Control (Standard Nutritional Drink)

Experimental: Prior Intervention - enhanced micronutrients, probiotics, myo-inositol in preconception & pregnancy - NiPPeR Study intervention drink containing a mix of micronutrients, probiotics and myo-inositol given to the mother during preconception & pregnancy

Active Comparator: Prior Control - standard micronutrients in preconception & pregnancy - NiPPeR Study control nutritional drink containing a mix of micronutrients given to the mother during preconception & pregnancy


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

Other interventions: Control (Standard Nutritional Drink)
Control nutritional drink containing a standard mix of micronutrients
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Child Body Mass Index (kg/m2), derived from weight and height
Timepoint [1] 0 0
Up to age 8 years, from periconception to age 8 years
Primary outcome [2] 0 0
Intellectual function (WASI-II IQ [4 sub-test scores], higher score is a higher IQ)
Timepoint [2] 0 0
Up to age 8 years, from periconception to age 8 years
Primary outcome [3] 0 0
Child insulin resistance (HOMA2-IR [no units], higher value is greater insulin resistance)
Timepoint [3] 0 0
Up to age 8 years, from periconception to age 8 years
Primary outcome [4] 0 0
Dimensional Change Card Sort Test (raw & T-scores)
Timepoint [4] 0 0
Up to age 8 years, from periconception to age 8 years
Primary outcome [5] 0 0
Flanker Inhibitory Control & Attention Test (raw & T-scores)
Timepoint [5] 0 0
Up to age 8 years, from periconception to age 8 years
Primary outcome [6] 0 0
Strengths & Difficulties Questionnaire score (no units)
Timepoint [6] 0 0
Up to age 8 years, from periconception to age 8 years
Primary outcome [7] 0 0
Child Behaviour Check List score (no units)
Timepoint [7] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [1] 0 0
Body fat mass (kg, % and indices)
Timepoint [1] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [2] 0 0
Change in body fat mass (kg)
Timepoint [2] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [3] 0 0
Body lean mass (kg, % and indices)
Timepoint [3] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [4] 0 0
Change in lean mass (kg)
Timepoint [4] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [5] 0 0
Body bone mass (kg, % and indices)
Timepoint [5] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [6] 0 0
Change in bone mass (kg)
Timepoint [6] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [7] 0 0
Child height (cm)
Timepoint [7] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [8] 0 0
Height growth (cm)
Timepoint [8] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [9] 0 0
Change in body mass index (z-score & percentile)
Timepoint [9] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [10] 0 0
Change in weight (kg)
Timepoint [10] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [11] 0 0
Child mid-upper arm circumference (cm)
Timepoint [11] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [12] 0 0
Change in mid-upper circumference (z-score)
Timepoint [12] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [13] 0 0
Child waist circumference (cm)
Timepoint [13] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [14] 0 0
Change in waist circumference (z-score)
Timepoint [14] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [15] 0 0
Heart rate response to step test (beats per minute)
Timepoint [15] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [16] 0 0
Child blood pressure (mm Hg)
Timepoint [16] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [17] 0 0
Child resting heart rate (beats per minute)
Timepoint [17] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [18] 0 0
Child minutes to return to resting heart rate (minutes)
Timepoint [18] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [19] 0 0
Diagnosed medical conditions or disorders ascertained by questionnaire, including child medical conditions, infections, gastrointestinal, cardiovascular, respiratory, dermatological, neuropsychological, mental and musculoskeletal health and wellbeing
Timepoint [19] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [20] 0 0
Dietary patterns ascertained by frequency questionnaires
Timepoint [20] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [21] 0 0
Child Eating Behaviour Questionnaire
Timepoint [21] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [22] 0 0
Parental Feeding Practices Questionnaire
Timepoint [22] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [23] 0 0
Children's Sleep Habits Questionnaire
Timepoint [23] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [24] 0 0
Children's actigraphy measurements of activity behaviours [minutes/day]
Timepoint [24] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [25] 0 0
Child Movement Behaviour Questionnaire
Timepoint [25] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [26] 0 0
Skin pricks test results to allergens [mm]
Timepoint [26] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [27] 0 0
Child asthma, wheezing illnesses, eczema, rhinitis and food allergy by clinical examination & questionnaires
Timepoint [27] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [28] 0 0
Hair metabolome panel concentrations (pmol/L)
Timepoint [28] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [29] 0 0
Urine micronutrient concentrations (nmol/L)
Timepoint [29] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [30] 0 0
Blood micronutrient concentrations (nmol/L)
Timepoint [30] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [31] 0 0
Blood trace element concentrations (pmol/L)
Timepoint [31] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [32] 0 0
Urine trace element concentrations (pmol/L)
Timepoint [32] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [33] 0 0
Stool metagenomic profile (abundance)
Timepoint [33] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [34] 0 0
Skin metagenomic profile (abundance)
Timepoint [34] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [35] 0 0
Stool metatranscriptomic profile (relative activity)
Timepoint [35] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [36] 0 0
Skin metatranscriptomic profile (relative activity)
Timepoint [36] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [37] 0 0
Stool metabolomic profile (pmol/L)
Timepoint [37] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [38] 0 0
Skin metabolomic profile (pmol/L)
Timepoint [38] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [39] 0 0
Blood molecular profile (% methylation)
Timepoint [39] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [40] 0 0
Buccal molecular profile (% methylation)
Timepoint [40] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [41] 0 0
Blood transcriptomic profile (relative expression)
Timepoint [41] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [42] 0 0
Buccal transcriptomic profile (relative expression)
Timepoint [42] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [43] 0 0
Genetic variation (DNA sequence analysis)
Timepoint [43] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [44] 0 0
Circulating chemocytokine measurements (nmol/L)
Timepoint [44] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [45] 0 0
Circulating adipokine measurements (nmol/L)
Timepoint [45] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [46] 0 0
Circulating inflammatory marker measurement (nmol/L)
Timepoint [46] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [47] 0 0
Plasma glucose concentration (mmol/L)
Timepoint [47] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [48] 0 0
Plasma lipid concentrations (mmol/L)
Timepoint [48] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [49] 0 0
Plasma high-sensitivity C-reactive protein concentrations (mmol/L)
Timepoint [49] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [50] 0 0
Blood metabolome panel concentrations (pmol/L)
Timepoint [50] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [51] 0 0
Urine metabolome panel concentrations (pmol/L)
Timepoint [51] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [52] 0 0
Urine measurement of environmental pollutant exposure (pmol/L)
Timepoint [52] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [53] 0 0
Blood measurement of environmental pollutant exposure (ng/gm lipid)
Timepoint [53] 0 0
Up to age 8 years, from periconception to age 8 years
Secondary outcome [54] 0 0
Hair measurement of environmental pollutant exposure (pmol/L)
Timepoint [54] 0 0
Up to age 8 years, from periconception to age 8 years

Eligibility
Key inclusion criteria
All children still participating in the NiPPeR study at 6-8 years.
Minimum age
6 Years
Maximum age
8 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Known significant congenital anomaly or genetic condition that influences child growth or
neurodevelopment.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2026
Actual
Sample size
Target
510
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
Singapore
State/province [2] 0 0
Singapore
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Hampshire

Funding & Sponsors
Primary sponsor type
Other
Name
University of Southampton
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
National University Hospital, Singapore
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/Industry
Name [2] 0 0
Auckland UniServices Ltd.
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Singapore Institute for Clinical Sciences
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
National University of Singapore
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
National University Health System, Singapore
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Auckland, New Zealand
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05934422
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Wayne S Cutfield, MB MD FRACP
Address 0 0
The University of Auckland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05934422