Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000595415
Ethics application status
Approved
Date submitted
27/04/2016
Date registered
9/05/2016
Date last updated
4/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Screening for childhood obesity and vascular conditions
Scientific title
Prevalence of obesity and vascular conditions in children aged 9-10 years from the SCOPE (Screening for Pregnancy Endpoints) study.
Secondary ID [1] 289005 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 298412 0
Vascular diseases 298612 0
Condition category
Condition code
Cardiovascular 298510 298510 0 0
Coronary heart disease
Diet and Nutrition 298680 298680 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Children born to mothers that participated in SCOPE study (ANZCTRN12607000551493). will be included in current follow up study.
Prevalence of obesity and vascular impairment among children born of complicated pregnancies including preeclampsia, gestational hypertension, small for gestational age, spontaneous preterm birth and gestational diabetes will be compared with that of children born after uncomplicated pregnancies.
Participation in the study involves a single session of approximately 1 hour.
Intervention code [1] 294489 0
Early Detection / Screening
Comparator / control treatment
Children born of uncomplicated pregnancies
Control group
Active

Outcomes
Primary outcome [1] 298005 0
Prevalence of obesity will be assessed.
The height and weight will be measured from which BMI will be calculated. Overweight is defined as a BMI at or above the 85th percentile and below the 95th percentile for age and sex. Obesity is defined as a BMI at or above the 95th percentile for age and sex.
Timepoint [1] 298005 0
Prevalence of obesity will be assessed at 9-10 years of age
Secondary outcome [1] 322885 0
Prevalence of high blood pressure,
Blood pressure will be measured using a sphygmomanometer.
Timepoint [1] 322885 0
At 9-10 years of age
Secondary outcome [2] 323526 0
Prevalence of reduced cardiac output.
The cardiac output will be measured non invasively using the USCOM 1A machine.
Timepoint [2] 323526 0
At 9-10 years of age
Secondary outcome [3] 323527 0
Prevalence of increased vascular stiffness

Vascular stiffness will be measured non invasively using the USCOM BP+ machine
Timepoint [3] 323527 0
At 9-10 years of age
Secondary outcome [4] 323528 0
Prevalence of impaired microvascular function

Microvascular function will be assessed noninvasively using Laser Doppler.
Timepoint [4] 323528 0
At 9-10 years of age
Secondary outcome [5] 323531 0
Diet

Dietary information will be obtained using the Food Frequency Questionnaire administered by the interviewer
Timepoint [5] 323531 0
9-10 years of age
Secondary outcome [6] 323532 0
Level of exercise

Level of exercise will be assessed by interviewer administered questions
Timepoint [6] 323532 0
9-10 years of age

Eligibility
Key inclusion criteria
All children of women recruited to the SCOPE pregnancy study between 2005-2008
Minimum age
9 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None - all children will be invited

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Data of children born after complicated pregnancies will be compared with that of children born after uncomplicated pregnancies. Logistic and linear regression will be used for data analyses.

A previous study on assessing vascular function in obese kids compared to kids with normal BMI reports higher peak perfusion and longer recovery time among obese kids (Schlager et al., 2011). With the effect size observed in this study, a sample size of 800 will give 90% power at 5% significance level. Therefore, we expect the proposed study to be adequately powered.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/05/2016
Actual
12/05/2016
Date of last participant enrolment
Anticipated
6/06/2018
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
171
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 5629 0
Lyell McEwin Hospital - Elizabeth Vale
Recruitment postcode(s) [1] 13076 0
5112 - Elizabeth Vale

Funding & Sponsors
Funding source category [1] 293376 0
Charities/Societies/Foundations
Name [1] 293376 0
Channel 7 Children's Research Foundation
Country [1] 293376 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Discipline of Obstetrics and Gynaecology, School of Medicine, Level 6, Medical School North, University of Adelaide, 30, Frome Road, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 292193 0
None
Name [1] 292193 0
Address [1] 292193 0
Country [1] 292193 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294833 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 294833 0
72, King William Road, North Adelaide, SA 5006
Ethics committee country [1] 294833 0
Australia
Date submitted for ethics approval [1] 294833 0
16/12/2015
Approval date [1] 294833 0
24/02/2016
Ethics approval number [1] 294833 0
HREC/15/WCHN/192

Summary
Brief summary
The main pregnancy complications preeclampsia, gestational hypertension, small for gestational age pregnancy (SGA) and spontaneous preterm birth are associated with adverse health outcomes for the mother and offspring. Maternal preeclampsia and gestational hypertension are associated with higher blood pressure in the offspring as early as at 6 years of age and a higher risk for coronary artery disease (CAD) in the offspring in adult life. Emerging evidence suggest that children born SGA or born preterm are also at a similar increased risk.
We aim to identify early cardiovascular risk factors including obesity and vascular impairment among children aged 9-10 years.
The proposed study includes children aged between 9-10 years from the SCOPE (Screening for Pregnancy Endpoints) study. The SCOPE study was conducted in Adelaide during 2005-2008 and 1164 nulliparous pregnant women, their partners and babies were recruited. Detailed information was collected during pregnancy. Of the 1164 women in the study, 861 had uncomplicated pregnancies, 93 developed preeclampsia, 118 had gestational hypertension, 95 normotensive women delivered SGA babies and 69 delivered preterm.
We will invite all children of women recruited to the SCOPE study to participate at age 9-10 years. Data will be collected on diet, physical activity, height and weight. Haemodynamic measures will be done noninvasively as follows. Central blood pressure and augmentation index (an indicator of arterial stiffness) will be measured using the USCOMBP+. Cardiac output and systemic vascular resistance will be measured using the USCOM 1A. Microvascular function will be assessed by Post Occlusive Reactive Hyperaemia method using Laser Doppler. The results of children born after complicated pregnancies will be compared with those of children born after uncomplicated pregnancies.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65182 0
Prof Claire Roberts
Address 65182 0
Discipline of Obstetrics and Gynaecology, School of Medicine, Level 6, Medical School North, University of Adelaide, Frome Road, Adelaide, SA 5000
Country 65182 0
Australia
Phone 65182 0
(+61) 8 8313 3118
Fax 65182 0
(+61) 8 8313 4099
Email 65182 0
[email protected]
Contact person for public queries
Name 65183 0
Prabha Andraweera
Address 65183 0
Discipline of Obstetrics and Gynaecology, School of Medicine, Level 6, Medical School North, University of Adelaide, Frome Road, Adelaide, SA 5000
Country 65183 0
Australia
Phone 65183 0
(+61) 8 8313 4086
Fax 65183 0
(+61) 8 8313 4099
Email 65183 0
[email protected]
Contact person for scientific queries
Name 65184 0
Prabha Andraweera
Address 65184 0
Discipline of Obstetrics and Gynaecology, School of Medicine, Level 6, Medical School North, University of Adelaide, Frome Road, Adelaide, SA 5000
Country 65184 0
Australia
Phone 65184 0
(+61) 8 8313 4086
Fax 65184 0
(+61) 8 8313 4099
Email 65184 0
[email protected]

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