A pregnancy intervention to reduce postprandial glucose excursions in the primary prevention of paediatric obesity

ISRCTN	ISRCTN10344179
DOI	https://doi.org/10.1186/ISRCTN10344179
Protocol serial number	NHMRC Project Grant 512363
Sponsor	National Health and Medical Research Council (Australia)
Funder	National Health and Medical Research Council (NHMRC) (Australia): application for project grant in 2007 for funding in 2008

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Jennie Brand-Miller
Scientific

Human Nutrition Unit
University of Sydney
NSW 2006
Sydney
2006
Australia

Email	j.brandmiller@mmb.usyd.edu.au

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A pregnancy intervention to reduce postprandial glucose excursions in the primary prevention of paediatric obesity: a randomised controlled trial
Study acronym	CHOPP (Childhood Obesity Primary Prevention Study)
Study objectives	A diet designed to reduce maternal blood glucose levels will reduce the prevalence of large gestational age and childhood obesity.
Ethics approval(s)	To be submitted to the University of Sydney Human Ethics Committee and relevant teaching hospitals
Health condition(s) or problem(s) studied	Pregnancy, obesity
Intervention	A conventional healthy diet or a low glycaemic index diet from 12 to 16 weeks gestation for the remainder of pregnancy.
Intervention type	Other
Primary outcome measure(s)	1. Prevalence of large gestational age at birth (more than 90th centile) 2. Prevalence of childhood obesity as determined by BMI
Key secondary outcome measure(s)	1. Prevalence of gestational diabetes 2. Ponderal index 3. Prevalence of 'small for gestational age'
Completion date	31/12/2012

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	1650
Key inclusion criteria	Healthy pregnant women at 12 to 16 weeks gestation who agree to be randomised
Key exclusion criteria	1. Women with pre-gestational diabetes 2. Multiple birth 3. Assisted reproduction 4. Special diet or referred to a dietitian for other reasons
Date of first enrolment	01/01/2008
Date of final enrolment	31/12/2012

Human Nutrition Unit

Sydney
2006
Australia

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/2006		Yes	No

27/09/2017: internal review.