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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
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Scientific title
Body composition changes during pregnancy & early infancy
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Secondary ID [1]
299452
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None
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Universal Trial Number (UTN)
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Trial acronym
The Koru Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Body composition
314656
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Physical activity
314657
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Energy intake
314658
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Condition category
Condition code
Diet and Nutrition
312991
312991
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0
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Obesity
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Reproductive Health and Childbirth
312992
312992
0
0
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Normal pregnancy
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Blood
313033
313033
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0
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Anaemia
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Metabolic and Endocrine
313095
313095
0
0
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Normal metabolism and endocrine development and function
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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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.
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Intervention code [1]
315696
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Early Detection / Screening
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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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).
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Assessment method [1]
321560
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Timepoint [1]
321560
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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
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Primary outcome [2]
321561
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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)
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Assessment method [2]
321561
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Timepoint [2]
321561
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Their infants, single measurement between:
7-14 days old [primary timepoint]
4-6 weeks old
14-16 weeks old
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Primary outcome [3]
321562
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Investigating gestational weight gain advice pregnant women received as assessed by study specific questionnaire.
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Assessment method [3]
321562
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Timepoint [3]
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Single assessment in each of the time periods listed below.
9-13 weeks gestation
23-26 weeks gestation
33-36 weeks gestation [primary timepoint]
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Secondary outcome [1]
375368
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To investigate maternal energy intake by 4-day weighed diet diary during each pregnancy trimester and at four months postpartum.
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Assessment method [1]
375368
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Timepoint [1]
375368
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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
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Secondary outcome [2]
375369
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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).
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Assessment method [2]
375369
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Timepoint [2]
375369
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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
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Secondary outcome [3]
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To investigate resting metabolic rate by a metabolic cart during each pregnancy trimester and postnatallly up to 4 months
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Assessment method [3]
375743
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Timepoint [3]
375743
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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
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Secondary outcome [4]
375744
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To investigate maternal selenium status (assessed by testing venous blood samples) at trimester one and postnatally at 4 months.
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Assessment method [4]
375744
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Timepoint [4]
375744
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Single assessment in each of the periods listed below
9-13 weeks gestation
14-16 weeks postpartum
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Secondary outcome [5]
375745
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To investigate maternal iodine status (assessed by testing urine samples) during each pregnancy trimester and postnatally up to 4 months.
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Assessment method [5]
375745
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Timepoint [5]
375745
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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
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Secondary outcome [6]
375746
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To investigate maternal iron status (assessed by testing venous & spot blood samples) during each pregnancy trimester and postnatally up to 4 months.
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Assessment method [6]
375746
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Timepoint [6]
375746
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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
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Secondary outcome [7]
375747
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To investigate maternal folate status (assessed by testing venous blood samples) during trimester one and postnatally at 4 months.
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Assessment method [7]
375747
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Timepoint [7]
375747
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Single assessment in each of the periods listed below
9-13 weeks gestation
14-16 weeks postpartum
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Secondary outcome [8]
375767
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Measure maternal thyroid function (assessed by testing venous blood samples) during trimester one and postnatally at 4 months.
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Assessment method [8]
375767
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Timepoint [8]
375767
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Single assessment in each of the periods listed below
9-13 weeks gestation
14-16 weeks postpartum
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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.
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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)
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Convenience sample
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Timing
Prospective
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2019
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Actual
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Date of last participant enrolment
Anticipated
31/12/2020
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Actual
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Date of last data collection
Anticipated
27/08/2021
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Actual
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Sample size
Target
102
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
21897
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New Zealand
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State/province [1]
21897
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Lower North Island
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Funding & Sponsors
Funding source category [1]
303954
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University
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Name [1]
303954
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Massey University.
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Address [1]
303954
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School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
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Country [1]
303954
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New Zealand
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Primary sponsor type
Individual
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Name
Dr Louise Brough
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Address
School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
304123
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Individual
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Name [1]
304123
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Ciara Funnell
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Address [1]
304123
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School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
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Country [1]
304123
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
304454
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
304454
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Ministry of Health,
Central Health and Disability Ethics Committee,
PO Box 5013,
Wellington 6140
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Ethics committee country [1]
304454
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New Zealand
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Date submitted for ethics approval [1]
304454
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12/03/2019
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Approval date [1]
304454
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01/07/2019
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Ethics approval number [1]
304454
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19/CEN/47
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Summary
Brief summary
Managing weight gain during pregnancy is important for positive health outcomes of both mother and infant. Currently, best practice guidelines for pregnancy follow a weight focused model with recommendations of weight gain during pregnancy based on pre-pregnancy body mass index (BMI). However, unfavourable changes in body composition (e.g. excessive body fat) result in poor health outcomes rather than weight gain in isolation.
Research is lacking into body composition changes during pregnancy and its link to infant weight and body composition at birth and in early life. The Koru Study will measure body composition changes during pregnancy using air displacement plethysmography (BodPod®) and also infant body composition in early life using a Peapod®.
Energy expenditure will be investigated by measuring physical activity during and post pregnancy in combination with dietary intake and resting metabolic energy.
Dietary advice received during pregnancy will also be investigated.
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Trial website
https://www.thekorustudy.com/
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mrs Ciara Funnell
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Address
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School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
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Country
97002
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New Zealand
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Phone
97002
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+64 6 9516366
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Fax
97002
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Email
97002
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[email protected]
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Contact person for public queries
Name
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Mrs Ciara Funnell
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Address
97003
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School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
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Country
97003
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New Zealand
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Phone
97003
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+64 6 9516366
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Fax
97003
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Email
97003
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[email protected]
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Contact person for scientific queries
Name
97004
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Dr Louise Brough
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Address
97004
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School of Food and Advanced Technology
College of Sciences
Massey University
Private Bag 11 222
Palmerston North, 4442
New Zealand
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Country
97004
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New Zealand
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Phone
97004
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+64 6 9514575
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Fax
97004
0
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Email
97004
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
5173
Ethical 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.
Download to PDF