ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000374460

Ethics application status

Approved

Date submitted

10/05/2007

Date registered

16/07/2007

Date last updated

29/02/2016

Type of registration

Retrospectively registered

Titles & IDs

Public title

Romp & Chomp: A community-based intervention program to promote healthy eating and physical activity in under 5s in the City of Greater Geelong

Scientific title

A study in pre-school children of multiple strategies to increase the community's capacity to promote healthy eating and physical activity compared to no specific interventions on the prevalence of overweight and obesity

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Overweight and obesity in pre-school children.

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Intervention: Multiple strategies over 3 years (2005-2008) to increase community capacity to increase healthy eating and physical activity in pre-school children. Examples of strategies include food policies in child care settings, active play programs, social marketing, promotion of water, training of early childhood professionals, and parent education.

Intervention code [1]

Prevention

Comparator / control treatment

Comparison: Background activities in the region, no specific interventions, comparison period will be the same 3 years (2005-2008).

Control group

Active

Outcomes

Primary outcome [1]

Change in the prevalence of overweight and obesity calculated from measured height and weight from routinely collected anthropometry in 2 and 3.5 year olds.

Timepoint [1]

Serial cross-sectional measurements (different children each year) taken throughout the year. Pre-intervention trends (2000-2005) will be compared to trends during the intervention period (2005-8) in both intervention and comparison populations.

Secondary outcome [1]

Behavioural indicators of healthy eating and physical activity (parent questionnaire)

Timepoint [1]

Measured at baseline (2005-2006) and after 3 years of intervention (2008-9)

Secondary outcome [2]

Settings audits (questionnaire)

Timepoint [2]

Measured at baseline (2005-2006) and after 3 years of intervention (2008-9)

Eligibility

Key inclusion criteria

Inclusion for anthropometry: All children attending Maternal and Child Health (MCH) Key Age and Stages visits for 2 and 3.5 years Inclusion for behaviours: Parents attending MCH 2 and 3.5 year Age and Stage visits within the data collection time period. Inclusions for Settings audits: Kindergartens, long daycare, family daycare settings in the intervention and comparison areas.

Minimum age

2 Years

Maximum age

4 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion for anthropometry: participants with missing data and outlying data indicating data entry errors. Exclusions for audits: nil

Study design

Purpose of the study

Prevention

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 4

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/07/2005

Actual

5/04/2005

Date of last participant enrolment

Anticipated

Actual

1/01/2008

Date of last data collection

Anticipated

Actual

Sample size

Target

30000

Accrual to date

Final

36000

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Human Services, Victoria

Address [1]

Lonsdale St Melbourne Vic 3000

Country [1]

Australia

Primary sponsor type

University

Name

School of Exercise and Nutrition Sciences, Deakin University

Address

Gheringhap Street,
Geelong, Victoria 3217,

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Victorian Government, Office for Children

Address [1]

Lonsdale St Melbourne 3000 Vic

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

All kindergartens, long day care, family day care and MCH sites across Victoria-Deakin University Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

04/04/2005

Ethics approval number [1]

EC 23-2005

Summary

Brief summary

A Multi-strategy intervention program in Geelong aims to promote healthy eating and physical activity and reduce overweight and obesity in pre-school children compared children across the rest of Victoria.

Trial website

Trial related presentations / publications

Bell C, Simmons A, Sanigorski A, Kremer P, Swinburn B.  Preventing childhood obesity: the sentinel site for obesity prevention in Victoria, Australia.  Health Promot Int 2008; 23(4):328-336
Bennett CA, de Silva-Sanigorski A, Nichols M, Bell AC, Swinburn BA. Assessing the intake of obesity-related foods and beverages in young children: comparison of a simple population survey with 24 hr recall. Int J Behav Nutr Phys Act 2009; 6:71
De Groot FP, Robertson NM, Swinburn BA, de Silva-Sanigorski AM.  Increasing community capacity to prevent childhood obesity: challenges, lessons learned and results from the Romp & Chomp intervention. BMC Public Health 2010; 10:522
De Silva-Sanigorski A, Elea D, Bell C, Kremer P, Carpenter L, Nichols M, Smith M, Sharp S, Boak R, Swinburn B. Obesity prevention in the family day care setting: the impact of the Romp & Chomp intervention on opportunities for children’s physical activity and healthy eating. Child Care Health Dev. 2011; 37(3):385-393 
Nichols MA, de Silva-Sanigorski, Cleary J, Goldfeld  SR, Colahan A, Swinburn B. Decreasing trends in overweight and obesity among an Australian population of preschool children. Int J Obes 2011; 35(7):916-924
de Silva-Sanigorski AM, Bell AC, Kremer P, Park J, Demajo L, Smith M, Sharp S, Nichols M, Carpenter L, Boak R, Swinburn B. Process and impact evaluation of the Romp & Chomp obesity prevention intervention in early childhood settings: lessons learned from implementation in preschools and long day care settings. Child Obes 2012; 8(3):205-215 
de Silva-Sanigorski AM, Bell AC, Kremer P, Nichols M, Crellin M, Smith M, Sharp S, de Groot F, Carpenter L, Boak R, Robertson N, Swinburn BA. Reducing obesity in early childhood: Results from Romp & Chomp, an Australian community-wide intervention program. Am J Clin Nutr  2010; 91:831-840

Public notes

Contacts

Principal investigator

Name

Prof Boyd Swinburn

Address

Gheringhap Street,
Geelong, Victoria 3217,

Country

Australia

Phone

+64221679636

Fax

boyd.swinburn@deakin.edu.au

Contact person for public queries

Name

Boyd swinburn

Address

Deakin University
Waterfront Campus
1 Gheringhap St
Geelong VIC 3127

Country

Australia

Phone

+61 3 52270369

Fax

boyd.swinburn@deakin.edu.au

Contact person for scientific queries

Name

Boyd Swinburn

Address

Deakin University
221 Burwood Highway
Melbourne VIC 3125

Country

Australia

Phone

+61 3 92517096

Fax

boyd.swinburn@deakin.edu.au

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.

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