Condition category
Pregnancy and Childbirth
Date applied
18/01/2007
Date assigned
09/02/2007
Last edited
25/07/2007
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jennie Brand-Miller

ORCID ID

Contact details

Human Nutrition Unit
University of Sydney
NSW 2006
Sydney
2006
Australia
j.brandmiller@mmb.usyd.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NHMRC Project Grant 512363

Study information

Scientific title

Acronym

CHOPP (Childhood Obesity Primary Prevention Study)

Study hypothesis

A diet designed to reduce maternal blood glucose levels will reduce the prevalence of large gestational age and childhood obesity.

Ethics approval

To be submitted to the University of Sydney Human Ethics Committee and relevant teaching hospitals

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

1. Prevalence of large gestational age at birth (more than 90th centile)
2. Prevalence of childhood obesity as determined by BMI

Secondary outcome measures

1. Prevalence of gestational diabetes
2. Ponderal index
3. Prevalence of 'small for gestational age'

Overall trial start date

01/01/2008

Overall trial end date

31/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy pregnant women at 12 to 16 weeks gestation who agree to be randomised

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

1650

Participant 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

Recruitment start date

01/01/2008

Recruitment end date

31/12/2012

Locations

Countries of recruitment

Australia

Trial participating centre

Human Nutrition Unit
Sydney
2006
Australia

Sponsor information

Organisation

National Health and Medical Research Council (Australia)

Sponsor details

GPO Box 1421
Canberra
2601
Australia
grantnet.help@nhmrc.gov.au

Sponsor type

Government

Website

http://www.nhmrc.gov.au/

Funders

Funder type

Government

Funder name

National Health and Medical Research Council (NHMRC) (Australia): application for project grant in 2007 for funding in 2008

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Pilot study of this trial: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=17023707

Publication citations

  1. Pilot study of this trial

    Moses RG, Luebcke M, Davis WS, Coleman KJ, Tapsell LC, Petocz P, Brand-Miller JC, Effect of a low-glycemic-index diet during pregnancy on obstetric outcomes., Am. J. Clin. Nutr., 2006, 84, 4, 807-812.

Additional files

Editorial Notes