Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001551381
Ethics application status
Not required
Date submitted
26/10/2017
Date registered
10/11/2017
Date last updated
10/11/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Relationship between feeding practices used by first-time mothers with their infants and childhood weight at 3.5 and 5 years
Scientific title
Maternal feeding practices at infant age 20 months: associations with childhood overweight at 3.5 and 5 years
Secondary ID [1] 293221 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record
POI: NCT00892983, www.clinicaltrials.gov
InFANT: ISRCTN81847050, www.isrctn.com
InFANT Extend: ACTRN12611000386932, www.anzctr.org.au
NOURISH: ACTRN12608000056392, www.anzctr.org.au

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight/obesity 305237 0
Condition category
Condition code
Diet and Nutrition 304542 304542 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Maternal feeding practices at infant age 20 months, measured using the Comprehensive Feeding Practices Questionnaire (CFPQ) in four Australasian trials; POI: NCT00892983, InFANT: ISRCTN81847050, InFANT Extend: ACTRN12611000386932, and
NOURISH: ACTRN12608000056392.
Intervention code [1] 299477 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303777 0
Overweight status. Weight and height were measured by study staff using standard protocols, and used to derive BMI z-scores (standardised for age and sex using WHO standards), For this analysis, overweight status was defined as any child having a BMI z-score greater than or equal to the 85th percentile (i.e. overweight and obese combined).
Timepoint [1] 303777 0
Child age 3.5 and 5 years
Secondary outcome [1] 340120 0
Impact of feeding practices on weight status at 3.5 and 5 years, moderated by weight status at 20 months
Timepoint [1] 340120 0
3.5 and 5 years

Eligibility
Key inclusion criteria
Healthy mother-child dyads participating in four childhood obesity prevention trials across Australia and New Zealand. Mothers >16 years of age and facility with English.
Minimum age
20 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Mothers: Psychiatric disorder or history of substance abuse
Infants: pre-term birth, low birth weight or diagnosis of congenital abnormality or physical/intellectual disability likely to affect feeding, physical activity or growth.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Data from mother-child dyads participating in four childhood obesity prevention trials across Australia and New Zealand were pooled (n=776). Each trial administered items from the Comprehensive Feeding Practices Questionnaire (CFPQ) to mothers when infants were approximately 20 months of age, and study staff measured children’s height and weight at 20 months, 3.5 and 5 years of age. Poisson regression was used to determine risk ratios (RR) for overweight (BMI z-score greater than or equal to the 85th percentile) at 3.5 and 5 years by CFPQ scores, adjusted for maternal BMI, age, education, and child sex. Models were stratified by overweight status at 20 months.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/08/2016
Date of last participant enrolment
Anticipated
Actual
1/08/2017
Date of last data collection
Anticipated
Actual
1/08/2017
Sample size
Target
776
Accrual to date
Final
776
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment outside Australia
Country [1] 9321 0
New Zealand
State/province [1] 9321 0

Funding & Sponsors
Funding source category [1] 297848 0
Government body
Name [1] 297848 0
National Health and Medical Research Council
Country [1] 297848 0
Australia
Funding source category [2] 297849 0
Other
Name [2] 297849 0
World Cancer Research Fund
Country [2] 297849 0
United Kingdom
Funding source category [3] 297850 0
Government body
Name [3] 297850 0
Health Research Council of New Zealand
Country [3] 297850 0
New Zealand
Primary sponsor type
Individual
Name
Jillian J Haszard
Address
Department of Human Nutrition, University of Otago, PO Box 56
Dunedin, 9054 New Zealand
Country
New Zealand
Secondary sponsor category [1] 296889 0
Individual
Name [1] 296889 0
Rebecca Byrne
Address [1] 296889 0
School of Exercise and Nutrition Sciences, Institute of Health and Biomedical Innovation
Queensland University of Technology Level 6, 62 Graham St South Brisbane QLD 4101 Australia
Country [1] 296889 0
Australia

Ethics approval
Ethics application status
Not required

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

Contacts
Principal investigator
Name 78590 0
Dr Jillian J Haszard
Address 78590 0
Department of Human Nutrition, University of Otago, Dunedin, 9054,
Country 78590 0
New Zealand
Phone 78590 0
+64 3 479 7959
Fax 78590 0
Email 78590 0
[email protected]
Contact person for public queries
Name 78591 0
Jillian J Haszard
Address 78591 0
Department of Human Nutrition, University of Otago, Dunedin, 9054,
Country 78591 0
New Zealand
Phone 78591 0
+64 3 479 7959
Fax 78591 0
Email 78591 0
[email protected]
Contact person for scientific queries
Name 78592 0
Jillian J Haszard
Address 78592 0
Department of Human Nutrition, University of Otago, Dunedin, 9054,
Country 78592 0
New Zealand
Phone 78592 0
+64 3 479 7959
Fax 78592 0
Email 78592 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.