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Trial registered on ANZCTR


Registration number
ACTRN12619001484134
Ethics application status
Approved
Date submitted
3/10/2019
Date registered
28/10/2019
Date last updated
28/10/2019
Date data sharing statement initially provided
28/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Koru Study: Body Composition Changes During Pregnancy & Early Infancy
Scientific title
Body composition changes during pregnancy & early infancy
Secondary ID [1] 299452 0
None
Universal Trial Number (UTN)
Trial acronym
The Koru Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Body composition 314656 0
Physical activity 314657 0
Energy intake 314658 0
Condition category
Condition code
Diet and Nutrition 312991 312991 0 0
Obesity
Reproductive Health and Childbirth 312992 312992 0 0
Normal pregnancy
Blood 313033 313033 0 0
Anaemia
Metabolic and Endocrine 313095 313095 0 0
Normal metabolism and endocrine development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
As an observational study, the objectives are to investigate body composition changes as measured by air displacement plethysmography (BODPOD®) during each trimester of pregnancy and postnatally up to 4 months (6 visits in total); Infant body composition changes as measured by air displacement plethysmography (PEAPOD®) at three visits until the infant is 4 months of age. To investigate dietary advice received during each trimester of pregnancy and postnatally at 4 months as measured by questionnaire. To investigate energy intake and physical activity measured via 4-day diet record and physical activity monitor (namely accelerometer) respectively, during each trimester of pregnancy and postnatally at 4 months. Investigating micronutrient status (namely iron, iodine, selenium and folate) as measured by blood and urine sampling during each trimester of pregnancy and postnatally up to 4 months. To investigate changes in resting metabolic rate during each trimester of pregnancy and postnatally up to 4 months.
Intervention code [1] 315696 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321560 0
Measure maternal anthropometry changes (fat &lean tissue) by air displacement plethysmography (BODPOD®) in each trimester of pregnancy and postpartum up to 4 months. Composite primary outcome (fat & lean tissue measured simultaneously).
Timepoint [1] 321560 0
Pregnant women single assessment between:
9-13 weeks gestation
23-26 weeks gestation
33-36 weeks gestation [primary timepoint]
7-14 days postpartum
4-6 weeks postpartum
14-16 weeks postpartum
Primary outcome [2] 321561 0
Measure infant anthropometry changes (fat & lean tissue) by air displacement plethysmography (PEAPOD®) during the first four months of life. Composite primary outcome (fat & lean tissue measured simultaneously)

Timepoint [2] 321561 0
Their infants, single measurement between:
7-14 days old [primary timepoint]
4-6 weeks old
14-16 weeks old
Primary outcome [3] 321562 0
Investigating gestational weight gain advice pregnant women received as assessed by study specific questionnaire.

Timepoint [3] 321562 0
Single assessment in each of the time periods listed below.
9-13 weeks gestation
23-26 weeks gestation
33-36 weeks gestation [primary timepoint]
Secondary outcome [1] 375368 0
To investigate maternal energy intake by 4-day weighed diet diary during each pregnancy trimester and at four months postpartum.
Timepoint [1] 375368 0
Single assessment in each of the periods listed below
9-13 weeks gestation
23-26 weeks gestation
33-36 weeks gestation
14-16 weeks postpartum
Secondary outcome [2] 375369 0
To investigate maternal physical activity (steps taken & heart rate) using an accelerometer during each pregnancy trimester and at four months postpartum. Composite secondary outcome (steps taken & heart rate measured simultaneously).
Timepoint [2] 375369 0
Single assessment in each of the periods listed below
9-13 weeks gestation
23-26 weeks gestation
33-36 weeks gestation
14-16 weeks postpartum
Secondary outcome [3] 375743 0
To investigate resting metabolic rate by a metabolic cart during each pregnancy trimester and postnatallly up to 4 months
Timepoint [3] 375743 0
Single assessment in each of the periods listed below
9-13 weeks gestation
23-26 weeks gestation
33-36 weeks gestation
4-6 weeks postpartum
14-16 weeks postpartum
Secondary outcome [4] 375744 0
To investigate maternal selenium status (assessed by testing venous blood samples) at trimester one and postnatally at 4 months.
Timepoint [4] 375744 0
Single assessment in each of the periods listed below
9-13 weeks gestation
14-16 weeks postpartum
Secondary outcome [5] 375745 0
To investigate maternal iodine status (assessed by testing urine samples) during each pregnancy trimester and postnatally up to 4 months.
Timepoint [5] 375745 0
Single assessment in each of the periods listed below
9-13 weeks gestation
23-26 weeks gestation
33-36 weeks gestation
4-6 weeks postpartum
14-16 weeks postpartum
Secondary outcome [6] 375746 0
To investigate maternal iron status (assessed by testing venous & spot blood samples) during each pregnancy trimester and postnatally up to 4 months.
Timepoint [6] 375746 0
Single assessment in each of the periods listed below
9-13 weeks gestation
23-26 weeks gestation
33-36 weeks gestation
4-6 weeks postpartum
14-16 weeks postpartum
Secondary outcome [7] 375747 0
To investigate maternal folate status (assessed by testing venous blood samples) during trimester one and postnatally at 4 months.
Timepoint [7] 375747 0
Single assessment in each of the periods listed below
9-13 weeks gestation
14-16 weeks postpartum
Secondary outcome [8] 375767 0
Measure maternal thyroid function (assessed by testing venous blood samples) during trimester one and postnatally at 4 months.
Timepoint [8] 375767 0
Single assessment in each of the periods listed below
9-13 weeks gestation
14-16 weeks postpartum

Eligibility
Key inclusion criteria
The target population for the study is healthy pregnant women who have conceived naturally with a singleton pregnancy only. Since the study will follow participating pregnant women and their infants until the baby is 4 months old, continued participation requires that the infant does not contract or suffer from any serious on-going health problems.
Postpartum women's newborn infants will be included in the study if they are healthy. These infants can be a boy or girl, and are aged between 7-14 days old and 4 months.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous pregnancy history of preterm birth, gestational diabetes, preeclampsia, and hypertension.
Multiple pregnancy
Pregnancy which has resulted in a serious on-going health condition(s)


Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
In 2017 there were 59,610 live births in New Zealand, (3045 in the Manawatu-Whanganui region). Assuming a 90% confidence level, a margin of error of 5% and a variability of 8% (8.1% low/high birthweight) we would need a sample size of 80 women (Charan & Biswas, 2013). Using a non-completion rate of 27% based on previous research carried out in this field. 102 women are required for recruitment.
Statistical analysis will be performed using IBM SPSS statistics 20 . Baseline data will be described using mean (standard deviation), median (25, 75 percentile) or frequencies summary statistics. ANOVA will be used to analysis the continuous variables.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
27/08/2021
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment outside Australia
Country [1] 21897 0
New Zealand
State/province [1] 21897 0
Lower North Island

Funding & Sponsors
Funding source category [1] 303954 0
University
Name [1] 303954 0
Massey University.
Country [1] 303954 0
New Zealand
Primary sponsor type
Individual
Name
Dr Louise Brough
Address
School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
Country
New Zealand
Secondary sponsor category [1] 304123 0
Individual
Name [1] 304123 0
Ciara Funnell
Address [1] 304123 0
School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
Country [1] 304123 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304454 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 304454 0
Ethics committee country [1] 304454 0
New Zealand
Date submitted for ethics approval [1] 304454 0
12/03/2019
Approval date [1] 304454 0
01/07/2019
Ethics approval number [1] 304454 0
19/CEN/47

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97002 0
Mrs Ciara Funnell
Address 97002 0
School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
Country 97002 0
New Zealand
Phone 97002 0
+64 6 9516366
Fax 97002 0
Email 97002 0
c.funnell@massey.ac.nz
Contact person for public queries
Name 97003 0
Ciara Funnell
Address 97003 0
School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
Country 97003 0
New Zealand
Phone 97003 0
+64 6 9516366
Fax 97003 0
Email 97003 0
c.funnell@massey.ac.nz
Contact person for scientific queries
Name 97004 0
Louise Brough
Address 97004 0
School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
Country 97004 0
New Zealand
Phone 97004 0
+64 6 9514575
Fax 97004 0
Email 97004 0
L.Brough@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5173Ethical approval    378486-(Uploaded-01-10-2019-08-21-59)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.