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Trial registered on ANZCTR


Registration number
ACTRN12614001264673
Ethics application status
Approved
Date submitted
25/08/2008
Date registered
3/12/2014
Date last updated
3/12/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Changing the home environment to support healthy physical activity and dietary patterns for children: a random controlled trial.
Scientific title
Comparison of home-based lifestyle support intervention strategies for obese children aged 4-11 years, relative to usual paediatric care as a means of improving physical activity and dietary patterns.
Secondary ID [1] 285628 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 3608 0
Condition category
Condition code
Diet and Nutrition 3765 3765 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Home visits by trained professionals (3 visits; at baseline, 2 weeks and 4 months all of approximately the same duration ie 1-1.25 hour) to assess obeseogenicity of the home environment, provision of a written report for parents and ongoing support for the family to make lifestyle changes. By ongoing support we mean provision of evidence based practical strategies for improving healthy eating and physical activity in families. Particular emphasis was in provision of advice in non-judgemental supportive manner, sensitive to socio-ecomomic determinants of obesity. This additional support was provided by phone-calls in between home visits 2-3. The total intervention time was 6 months.
Intervention code [1] 3321 0
Lifestyle
Intervention code [2] 290696 0
Treatment: Other
Comparator / control treatment
The control group was wait-listed (ie received the intervention 6 months after the initial intervention group). During the wait-list time period the child may have been seeing a paediatrician, GP or other health care professional for weight management (ie standard care).
Control group
Active

Outcomes
Primary outcome [1] 4662 0
Child's dietary patterns using a validated instrument. Parents completed the 24-item Children’s Dietary Questionnaire (CDQ) which generates four continuous scores (i.e. fruit and vegetables, non-core foods, fat from dairy, sweetened beverages). Non-core foods are defined as foods that are not essential to meet nutrient requirements and contain excess energy, fat, sugar and salt. The CDQ shows acceptable reliability (ICC 0.5 to 0.9) and relative validity at the group level for the fruit and vegetables and non-core food scores (Cronbach alpha 0.62 to 0.72).

Timepoint [1] 4662 0
6 months after the intervention commenced.
Primary outcome [2] 293694 0
Child's physical activity patterns using a validated instrument. Child activity patterns were measured using an adapted version of The Outdoor Play and Small Screen Entertainment Checklist. Parents reported the average time children spent per weekday and weekend day (in hours and minutes) (i) playing outdoors, (ii) doing moderate-vigorous physical activity, and (iii) using electronic media such as television and computers for both. Six items were added to the original checklist to explore average time spent per day (iv) participating in physical activity and (v) using small screen entertainment. Times were averaged (weighted for type of day) to calculate (1) daily activity (vigorous physical activity + outdoor play) and (2) daily sedentary activity.
Timepoint [2] 293694 0
6 months after the intervention commenced.
Secondary outcome [1] 7879 0
Child's Body Mass Index (BMI) z score. child weight and height were measured to the nearest 0.1kg and 0.1cm, using standardised scales and stadiometer. BMI was calculated (weight, kg/height, m2) and weight status determined by applying the IOTF cut-points. BMI z-scores were calculated using LMSGrowth Excel add-in which is based on 1990 United Kingdom reference data.
Timepoint [1] 7879 0
6 months after the intervention commenced

Eligibility
Key inclusion criteria
Children
BMI >95 percentile
Minimum age
4 Years
Maximum age
11 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with a medical condition with potential to impact on growth
Children currently receiving another intervention program other than usual paediatric care

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
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)
SA
Recruitment hospital [1] 3136 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 1116 0
5042

Funding & Sponsors
Funding source category [1] 3781 0
Charities/Societies/Foundations
Name [1] 3781 0
Channel 7 Children's Research Foundation
Address [1] 3781 0
PO Box 2438, Regency Park, SA 5942
Country [1] 3781 0
Australia
Primary sponsor type
University
Name
FLinders University
Address
1 Flinders Drive, Bedford Park, SA, 5042
Country
Australia
Secondary sponsor category [1] 3392 0
Hospital
Name [1] 3392 0
Flinders Medical Centre
Address [1] 3392 0
1 Flinders Drive, Bedford Park, SA, 5042
Country [1] 3392 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5845 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 5845 0
Flinders Medical Centre, 1 Flinders Drive, Bedford Park, SA 5042
Ethics committee country [1] 5845 0
Australia
Date submitted for ethics approval [1] 5845 0
Approval date [1] 5845 0
30/01/2008
Ethics approval number [1] 5845 0
136/07

Summary
Brief summary
This project is utilising a randomised controlled study to determine whether a novel home-based intervention focusing on altering the home environment results in short-term improvements in dietary, physical activity and sedentary behaviour patterns of children with obesity aged 4 -11 years. Eighty-four children, referred for management of obesity to Flinders Medical Centre (FMC), will be recruited over a two year period. Children will be randomised to receive a home-based lifestyle support intervention in addition to usual care by a paediatrician or to the control group (paediatrician care alone). Outcomes which will be assessed at six months after the intervention will include improvements in physical activity and dietary patterns of children. These outcomes will be assessed using both direct (accelerometer data) and indirect (questionnaire data) methods. The study hypothesis is that obese children enrolled in this study will have better dietary patterns, physical activity and sedentary behaviour patterns at 6 months from initial assessment compared to a control group of obese children receiving standard care
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28876 0
A/Prof Nicola Spurrier
Address 28876 0
Department of Paediatrics and Child Health, Flinders University, 1 Flinders Drive, Bedford Park, SA 5042
Country 28876 0
Australia
Phone 28876 0
61 429567533
Fax 28876 0
Email 28876 0
nicola.spurrier@flinders.edu.au
Contact person for public queries
Name 12033 0
Ms Liz Lowe
Address 12033 0
Department of Paediatrics and Child Health, 1 Flinders Drive
Flinders Medical Centre, Bedford Park, SA 5042
Country 12033 0
Australia
Phone 12033 0
+61 8 8240 8917
Fax 12033 0
Email 12033 0
elizabeth.lowe@health.sa.gov.au
Contact person for scientific queries
Name 2961 0
A/Prof Nicola Spurrier
Address 2961 0
Department of Paediatrics and Child Health
Flinders Medical Centre, 1 Flinders Drive, Bedford Park, SA 5042
Country 2961 0
Australia
Phone 2961 0
+61 8 82044459
Fax 2961 0
Email 2961 0
nicola.spurrier@flinders.edu.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