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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] 280747 0
Nil known'
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight and obesity 1683 0
Condition category
Condition code
Diet and Nutrition 1778 1778 0 0
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] 1634 0
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] 2485 0
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] 2485 0
At 2 and 3 years of age.
Secondary outcome [1] 4277 0
Duration of breastfeeding
Timepoint [1] 4277 0
Measured at 6 and 12 months
Secondary outcome [2] 4278 0
Introduction of solids
Timepoint [2] 4278 0
At 3, and 6 months
Secondary outcome [3] 4279 0
Reduced intake of sweetened drinks and an increased intake of fruit and vegetables
Timepoint [3] 4279 0
Measured at age 2 years
Secondary outcome [4] 4280 0
Amount of television viewing measured at age 2 years
Timepoint [4] 4280 0
Measured at age 2 years
Secondary outcome [5] 4281 0
Range of opportunities for active play
Timepoint [5] 4281 0
Measured at 2 years
Secondary outcome [6] 4282 0
Nutrition and physical activity levels in mothers and families
Timepoint [6] 4282 0
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
Gender
Females
Can healthy volunteers participate?
No
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
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)

Funding & Sponsors
Funding source category [1] 1928 0
Government body
Name [1] 1928 0
National Health and Medical Research Council
Address [1] 1928 0
Level 1, 16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 1928 0
Australia
Primary sponsor type
Government body
Name
Health Promotion Service, Sydney South West Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 1740 0
University
Name [1] 1740 0
University of Sydney
Address [1] 1740 0
The University of Sydney
NSW 2006
Australia
Country [1] 1740 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3590 0
Sydney South West Area Health Service
Ethics committee address [1] 3590 0
Research Development Office, Royal Prince Alfred Hospital, CAMPERDOWN NSW 2050
Ethics committee country [1] 3590 0
Australia
Date submitted for ethics approval [1] 3590 0
Approval date [1] 3590 0
06/04/2005
Ethics approval number [1] 3590 0
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 27568 0
Address 27568 0
Country 27568 0
Phone 27568 0
Fax 27568 0
Email 27568 0
Contact person for public queries
Name 10823 0
Dr Li Ming Wen
Address 10823 0
Health Promotion Service
Sydney South West Area Health Service
Level 9, King George V Building,
Missenden Road, Camperdown
NSW 2050
Country 10823 0
Australia
Phone 10823 0
+61 2 95159055
Fax 10823 0
+61 2 95159056
Email 10823 0
lmwen@email.cs.nsw.gov.au
Contact person for scientific queries
Name 1751 0
Dr Li Ming Wen
Address 1751 0
Health Promotion Service
Sydney South West Area Health Service
Level 9
King George V Building
Missenden Road
Camperdown NSW 2050
Country 1751 0
Australia
Phone 1751 0
+61 2 95159055
Fax 1751 0
+61 2 95159056
Email 1751 0
lmwen@email.cs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary