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Trial registered on ANZCTR


Registration number
ACTRN12610000789066
Ethics application status
Approved
Date submitted
21/09/2010
Date registered
23/09/2010
Date last updated
8/04/2019
Date data sharing statement initially provided
3/04/2019
Date results information initially provided
3/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Early Prevention of Obesity in Children (EPOCH) Collaboration
Scientific title
A prospective meta-analysis (PMA) of parent focused interventions for the prevention of obesity in early childhood
Secondary ID [1] 252727 0
Nil
Universal Trial Number (UTN)
Trial acronym
EPOCH Collaboration
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity in childhood 258221 0
Condition category
Condition code
Diet and Nutrition 258398 258398 0 0
Obesity
Public Health 258399 258399 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The PMA consists of four randomised controlled trials, which include some / all of the following parent focused interventions:
promotion of breastfeeding
promotion of responsive feeding
dietary and parenting advice regarding introduction of solid foods (the 'how' and 'what' of child feeding)
reducing television (TV) viewing in early childhood
promoting active playing
developing good sleeping habits
Duration of the interventions ranged from antenatally to 2 years of age
The intensity and frequency of sessions varied between trials. The least intense intervention comprised six 2 hourly sessions at 3 monthly intervals. The most intense comprised a mix of home visits and group based sessions for sleep and healthy eating the maximum being 10 sessions over a period of 18 months.
The sessions are delivered face to face by a range of different health care professionals.
Intervention code [1] 257237 0
Prevention
Intervention code [2] 257239 0
Behaviour
Comparator / control treatment
usual care (which varies according to study site and may include nurse home visits and self directed access to health clinics) plus some general child health messages in most trials
Control group
Active

Outcomes
Primary outcome [1] 259241 0
Body Mass Index (BMI) Z score accoding to World Health Organisation Reference Standards
Timepoint [1] 259241 0
at one timepoint between 18-24 months of age
Secondary outcome [1] 265650 0
Overweight/obesity prevalence, defined as BMI z-score of at least 2 standard deviations (SD) above the WHO reference
Timepoint [1] 265650 0
at one timepoint between 18-24 months of age
Secondary outcome [2] 368995 0
duration of any breastfeeding in weeks, continuous outcome (as assessed within included trials)
Timepoint [2] 368995 0
at one timepoint between 18-24 months of age
Secondary outcome [3] 368996 0
Dichotomous outcome: Any Breastfeeding <6 months vs Any Breastfeeding greater than or equal to 6 months (using continuous outcome data)
Timepoint [3] 368996 0
at one timepoint between 18-24 months of age
Secondary outcome [4] 368997 0
Combined grams of fruit and vegetables per day (as assessed within included trials).
Where only serves per day was assessed, conversion to grams was based on fruit serves per day (mean serving size 150g) and vegetable serves per day (mean serving size 75g).
Timepoint [4] 368997 0
at one timepoint between 18-24 months of age
Secondary outcome [5] 368998 0
Millilitres of sweet drinks per day: included fruit juice, fruit drinks, cordials, soft or fizzy drink, energy drinks, and diet drinks (flavoured milk not included)
(as assessed within included trials).
Timepoint [5] 368998 0
at one timepoint between 18-24 months of age
Secondary outcome [6] 368999 0
Grams of non-core foods (high energy, low nutrient density such as cakes, biscuits, sweets, chips etc.)
(as assessed within included trials)
Timepoint [6] 368999 0
at one timepoint between 18-24 months of age
Secondary outcome [7] 369000 0
Comprehensive Feeding Practices Questionnaire (CFPQ)
Timepoint [7] 369000 0
at one timepoint between 18-24 months of age
Secondary outcome [8] 369001 0
Average time sedentary behaviour in front of the TV (ie, TV viewing, DVD viewing, computer use and gaming) per day less than or equal to 1 hour versus > 1 hour (dichotomous)
(as assessed within included trials)
Timepoint [8] 369001 0
at one timepoint between 18-24 months of age
Secondary outcome [9] 369002 0
Longitudinal Study of Australian Children (LSAC) parenting question
Timepoint [9] 369002 0
at one timepoint between 18-24 months of age
Secondary outcome [10] 369003 0
The total night sleep duration (hours) (as assessed within included trials)
Timepoint [10] 369003 0
at one timepoint between 18-24 months of age
Secondary outcome [11] 369004 0
Total night sleep duration (Dichotomous outcome): <10.5 vs greater than or equal to 10.5 hours (as assessed within included trials)
Timepoint [11] 369004 0
at one timepoint between 18-24 months of age
Secondary outcome [12] 369005 0
Average daily outside play hours/day (as assessed within included trials)
Timepoint [12] 369005 0
at one timepoint between 18-24 months of age

Eligibility
Key inclusion criteria
for individual trials: first time mothers and their healthy infants
mothers and infant recruited onto trial before infant is aged 4 months

for PMA:
parent focused intervention for preventing obesity
investigators blinded to trials outcome when research plan agreed upon
minimum follow up of 18 months
each individual trial should be registered with appropriate trial registry
Minimum age
No limit
Maximum age
4 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
outside Australia or New Zealand

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment outside Australia
Country [1] 2926 0
New Zealand
State/province [1] 2926 0

Funding & Sponsors
Funding source category [1] 257681 0
Commercial sector/Industry
Name [1] 257681 0
Meat and Livestock Australia
Address [1] 257681 0
Meat and Livestock Australia
Locked Bag 991, North Sydney, NSW 2059
Country [1] 257681 0
Australia
Funding source category [2] 302405 0
Government body
Name [2] 302405 0
National Health and Medical Research Council
Address [2] 302405 0
16 Marcus Clarke St,
Canberra ACT 2601
Country [2] 302405 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Dr Lisa Askie
National Health and Medical Research Council (NHMRC) Clinical Trials Centre,
University of Sydney,
Level 6, Medical Foundation Building,
92 Paramatta Rd
Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 256898 0
None
Name [1] 256898 0
Address [1] 256898 0
Country [1] 256898 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303074 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 303074 0
Research Integrity & Ethics Administration
Level 2, Margaret Telfer Building (K07)
The University of Sydney
NSW 2006
Ethics committee country [1] 303074 0
Australia
Date submitted for ethics approval [1] 303074 0
Approval date [1] 303074 0
18/10/2016
Ethics approval number [1] 303074 0
2016/822

Summary
Brief summary
The Early Prevention of Obesity in Children (EPOCH) Collaboration was formed in 2009. The main objective of the EPOCH Collaboration is to determine using a prospective meta-analysis of four randomised trials if early interventions for childhood obesity impact on BMI z scores at age 18-24 months. Additional research questions will focus on whether the interventions have an impact on dietary quality of child, TV viewing time, duration of breastfeeding and parenting styles. The enlarged sample size of the combined dataset (approximately 1800) will allow greater reliability when exploring intervention effects, with respect to pre-specified participant- and intervention- level characteristics. It will also allow for examination of complex interactions that are likely to be of high clinical importance.
Individual trial registration numbers are listed below:
ACTRN 12607000168459- Healthy Beginnings
ACTRN 126080000056392- Nourish
ISRCTN 81847050- Infant Feeding Activity and Nutrition Trial (InFANT)
NCT 00892983- Prevention of Overweight in Infancy (POI NZ)
Trial website
None
Trial related presentations / publications
Public notes
Ethics approval was provided for this PMA before any data analysis was conducted.

Contacts
Principal investigator
Name 31667 0
Prof Lisa Askie
Address 31667 0
NHMRC Clinical Trials Centre, University of Sydney
92-94 Parramatta Rd,
Camperdown NSW 2050
Country 31667 0
Australia
Phone 31667 0
+61 2 9562 5000
Fax 31667 0
Email 31667 0
lisa.askie@ctc.usyd.edu.au
Contact person for public queries
Name 14914 0
Dr Seema Mihrshahi
Address 14914 0
School of Public Health, Charles Perkins Centre, University of Sydney, Sydney NSW 2006
Country 14914 0
Australia
Phone 14914 0
+61 2 8627 1855
Fax 14914 0
Email 14914 0
seema.mihrshahi@sydney.edu.au
Contact person for scientific queries
Name 5842 0
Prof Lisa Askie
Address 5842 0
National Health and Medical Research Council (NHMRC) Clinical Trials Centre,
University of Sydney,
Level 6, Medical Foundation Building,
92 Paramatta Rd
Camperdown, NSW 2050
Country 5842 0
Australia
Phone 5842 0
61 2 9562 5000
Fax 5842 0
Email 5842 0
lisa.askie@ctc.usyd.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected, after de-identification
When will data be available (start and end dates)?
Following completion of all analyses by the EPOCH Centre for Research Excellence (see https://www.earlychildhoodobesity.com/)
No end date determined
Available to whom?
The EPOCH Collaboration will give consideration to any requests from DSMC Chairpersons for sharing of de-identified data (either aggregate or IPD) should the need arise.
Available for what types of analyses?
only to achieve the aims in the approved proposal
How or where can data be obtained?
access subject to approvals by Principal Investigator, and there will be a requirement to sign data access agreement
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 1788 0
Study protocol
Citation [1] 1788 0
Link [1] 1788 0
Email [1] 1788 0
Other [1] 1788 0
Type [2] 1789 0
Ethical approval
Citation [2] 1789 0
Link [2] 1789 0
Email [2] 1789 0
Other [2] 1789 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary