ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12607000168459

Ethics application status

Approved

Date submitted

6/03/2007

Date registered

13/03/2007

Date last updated

27/06/2012

Type of registration

Prospectively registered

Titles & IDs

Public title

Early intervention of multiple home visits to prevent childhood obesity among a disadvantaged population: a home-based Randomised Controlled Trial

Scientific title

Early intervention of multiple home visits to prevent childhood obesity among a disadvantaged population: a home-based Randomised Controlled Trial

Secondary ID [1]

Nil known'

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Childhood overweight and obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A home based intervention is designed to compare the effect of an intensive, home-based early intervention for first-time mothers of newborn babies, versus usual care, on child and family eating patterns, television viewing, opportunities for physical activity and anthropometric measures.

First-time mothers with a newborn are eligible for enrolment in the study and will receive the following intervention:

· Intensive Home-Based Early Intervention delivered by a specially trained nurse over the first two years of life, promoting healthy feeding and physical activity and enhanced parent-child interaction;

·

The intervention comprises eight home visits from a specially trained community nurse delivering the staged intervention which includes one home visit before child's birth between gestation age of 24 and 36 weeks, and seven home visits after child's birth at 1, 3, 5, 9, 12, 15 and 24 months together with pro-active telephone support between the visits. The number of telephone calls needed will be determined by the nurses

Intervention code [1]

Prevention

Comparator / control treatment

Usual care (this is a current standard practice, comprising one home visit by a community nurse within a month of birth plus possible baby clinic visits).

Control group

Active

Outcomes

Primary outcome [1]

Level of overweight and obesity in children at 2 and 3 years of age measured by aged adjusted BMI. Body Mass Index (BMI) will be calculated as weight (kg) / height (metres) squared and children at two years of age will be classified as healthy weight, overweight or obese based on the international recommended age-standardised BMI cut points.

Timepoint [1]

At 2 and 3 years of age.

Secondary outcome [1]

Duration of breastfeeding

Timepoint [1]

Measured at 6 and 12 months

Secondary outcome [2]

Introduction of solids

Timepoint [2]

At 3, and 6 months

Secondary outcome [3]

Reduced intake of sweetened drinks and an increased intake of fruit and vegetables

Timepoint [3]

Measured at age 2 years

Secondary outcome [4]

Amount of television viewing measured at age 2 years

Timepoint [4]

Measured at age 2 years

Secondary outcome [5]

Range of opportunities for active play

Timepoint [5]

Measured at 2 years

Secondary outcome [6]

Nutrition and physical activity levels in mothers and families

Timepoint [6]

At 2 years

Eligibility

Key inclusion criteria

1. First time mothers to be who are able to communicate in English and lived in the local areas, 2. Mothers aged 18 years and over with children either males or females from birth to 3 years of age.

Minimum age

18 Years

Maximum age

Not stated

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

presence of a physical or intellectual disability in a child which is likely to influence physical activity or food habits; presence of a chronic health problem in a child likely to influence weight or height; inability of parents or carers to communicate in spoken English.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

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

Allocation to the Intervention is concealled by sealed opaque envelopes.

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

Using a randomisation table created by a computer software (i.e., computerised sequence generation) and stratified by site

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 1

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/05/2007

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

782

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

Level 1, 16 Marcus Clarke Street
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

Government body

Name

Health Promotion Service, Sydney South West Area Health Service

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Sydney

Address [1]

The University of Sydney
NSW 2006
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney South West Area Health Service

Ethics committee address [1]

Research Development Office, Royal Prince Alfred Hospital, CAMPERDOWN  NSW  2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

06/04/2005

Ethics approval number [1]

X04-0189

Summary

Brief summary

Despite the importance of preventing overweight and obesity in children, few primary prevention interventions have been shown to be effective. We propose a randomised controlled trial (RCT) of an original community-based home visiting intervention designed to improve family and behavioural risk factors for childhood overweight and obesity for first-time mothers in the most socially and economically disadvantaged areas of Sydney. It addresses the key research question:

Will an intensive home-based early intervention over the first two years of life increase healthy feeding and physical activity, enhance parent-child interaction and lead to reduced levels of overweight and obesity among children aged 3 years?

Trial website

http://healthybeginnings.net.au/

Trial related presentations / publications

Wen LM, Baur LA, Simpson JM, Rissel C, Flood VM.  Effectiveness of an early intervention on infant feeding practices and “tummy time”: randomised controlled trial.   Arch Pediatr Adolesc Med. 2011;165(8):701-707

Wen LM, Rissel C., Baur L, Lee E, Simpson J. Who is NOT likely to access the Internet for health information? Findings from first-time mothers in southwest Sydney, Australia. International journal of medical informatics. 2011; 80:406-11

Wen LM, Rissel C, Lee E, Baur LA, Simpson JM.Maternal smoking, weight status and dietary behaviours during pregnancy: findings from first-time mothers in southwest Sydney, Australia. ANZ J Obstet Gynaecol  2011;51:31-37 

Wen LM, Simpson JM, Baur LA, Rissel C, Flood VM.Family functioning and obesity risk behaviors: implications for early obesity intervention. Obesity 2011;19(6):1252-8     

Wen Li Ming; Flood Victoria M; Simpson Judy M; Rissel Chris; Baur Louise A. Dietary behaviours during pregnancy: findings from first-time mothers in southwest Sydney, Australia. The International Journal of Behavioral Nutrition and Physical Activity 2010;7:13.

Wen Li Ming; Baur Louise A; Simpson Judy M; Rissel Chris. Mothers’ awareness of their weight status & concern about their children. Australian and New Zealand Journal of Public Health 2010; 34(3): 293-7.

Wen Li Ming; Rissel Chris; Lee Eric. Smoke-free home status and parents’ smoking status among first-time mothers. Australian and New Zealand Journal of Public Health 2010; 34(5):532-533

Wardle K, Murphy D, Ireland L, Holbeck C, Davidson C, Wen LM, Rissel C. What we learnt – recruiting prenatal mothers to an RCT addressing the prevention of overweight in early childhood? AJAN in 2010, Vol 29,(20):41-45

Wen Li Ming; De Domenico Maria; Elliott Donna; Bindon Jeni; Rissel Chris. Evaluation of a feasibility study addressing risk factors for childhood obesity through home visits. Journal of Paediatrics and Child health 2009; 45(10): 577-81.

Wen Li Ming; Baur Louise A; Rissel Chris; Alperstein Garth; Simpson Judy M. Intention to breastfeed and awareness of health recommendations: findings from first-time mothers in southwest Sydney, Australia. International Breastfeeding Journal 2009; 4: 9.

Wen LM, Orr N, Rissel C. The role of ethnicity in determining access to and acceptability of home visiting for early childhood health and wellbeing. Australian Health Review 2007; 31(1): 132-139.

Zehle K, Wen LM, Orr N, Rissel C. “It’s Not an Issue at the Moment”: A qualitative study of mothers about childhood obesity. MCN The American Journal of Maternal / Child Nursing 2007; 32(1): 36-41.

Wen Li Ming; Baur Louise A; Rissel Chris; Wardle Karen; Alperstein Garth; Simpson Judy M. Early intervention of multiple home visits to prevent childhood obesity in a disadvantaged population: a home-based randomised controlled trial (Healthy Beginnings Trial). BMC public health 2007; 7: 76.


Zuo Y, Norberg M, Wen LM, Rissel C. Estimates of overweight and obesity among pre-school aged children in Melbourne and Sydney. J Nut Dietetics 2006; 63: 179-182.

Wen L M, Baur L, Wardle K, Rissel C, Balafas A. Health Beginnings: A User’s Guide. Health Promotion Service, Sydney South West Area Health Service, NSW Australia, 2010. ISBN 978-0-9805109-2-8

Wardle K, Wen L M, Baur L, Rissel C. Health Beginnings: A User’s Guide Part Two – Intervention Resources. Health Promotion Service, Sydney South West Area Health Service, NSW Australia 2010. ISBN 978-0-9805109-1-1

Wen LM, Baur LA, Simpson JM,  Wardle K, Flood VM.  Effectiveness of home based early intervention on children’s BMI at age 2: randomised controlled trial. BMJ 2012; 344:e3732

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Li Ming Wen

Address

Health Promotion Service
Sydney South West Area Health Service
Level 9, King George V Building,
Missenden Road, Camperdown
NSW 2050

Country

Australia

Phone

+61 2 95159055

Fax

+61 2 95159056

lmwen@email.cs.nsw.gov.au

Contact person for scientific queries

Name

Dr Li Ming Wen

Address

Health Promotion Service
Sydney South West Area Health Service
Level 9
King George V Building
Missenden Road
Camperdown NSW 2050

Country

Australia

Phone

+61 2 95159055

Fax

+61 2 95159056

lmwen@email.cs.nsw.gov.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

Source	Title	Year of Publication	DOI
Embase	Is there an association between early weight status and utility-based health-related quality of life in young children?.	2018	https://dx.doi.org/10.1007/s11136-018-1932-2
Embase	Interventions commenced by early infancy to prevent childhood obesity-The EPOCH Collaboration: An individual participant data prospective meta-analysis of four randomized controlled trials.	2020	https://dx.doi.org/10.1111/ijpo.12618
Embase	A review of registered randomized controlled trials for the prevention of obesity in infancy.	2021	https://dx.doi.org/10.3390/ijerph18052444

N.B. These documents automatically identified may not have been verified by the study sponsor.

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