Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12606000382572
Ethics application status
Approved
Date submitted
24/08/2006
Date registered
30/08/2006
Date last updated
30/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The "Kids on Track" program
Scientific title
A randomosed time series study investigating the effects of a community based group behavioural parenting proram for the treatment of child overweight and obesity.
Universal Trial Number (UTN)
Trial acronym
KOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood overweight and obesity 1348 0
Condition category
Condition code
Diet and Nutrition 1438 1438 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A psychoeducational group behavioural parenting program involving 4 two hour weekly group sessions and a 3mth follow up booster session. Key intervention components involved knowlege about overweight, nutrition, physical activity and motivation.
Intervention code [1] 1327 0
Behaviour
Comparator / control treatment
The waist list control group did not recieve any treatment or support initially but were allocated into a treatment group after 3 mths on the wait list.
Control group
Active

Outcomes
Primary outcome [1] 1975 0
1) Child and parent/primary carer: Body Mass Index score, waist circumference
Timepoint [1] 1975 0
Outcomes will be collected for the treatment group at baseline (1 week before tretment) and 3 mths post treatment while the waitlist control group outcomes will be collected 3 mth before, baseline (1 week before treatment) and 3 mths post treatment.
Primary outcome [2] 1976 0
2) Child daily: energy consumption, media viewing, physical activity
Timepoint [2] 1976 0
Outcomes will be collected for the treatment group at baseline (1 week before tretment) and 3 mths post treatment while the waitlist control group outcomes will be collected 3 mth before, baseline (1 week before treatment) and 3 mths post treatment.
Secondary outcome [1] 3443 0
Parental behaviours involving parenting style (The Parenting Scale), conflict (The Parent Problem Checklist), satisfaction (Parenting Sense of Competence Scale). 2) Participant satisfaction via a parent questionaire.
Timepoint [1] 3443 0
These outcomes will be collected for the treatment group at baseline (1 week before tretment) and 3 mths post treatment while the waitlist control group outcomes will be collected 3 mth before, baseline (1 week before treatment) and 3 mths post treatment.

Eligibility
Key inclusion criteria
Families included if: child between 3 and 10-years-old, had BMI at or greater than 85th percentile after adjusting for age/gender; one parent/primary care-giver attends all assessment and treatment sessions. Parents/caregivers are required to read a treatment manual and complete a child food intake and physical activity and media viewing monitoring inventories.
Minimum age
3 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Presence of a medical diagnosis for child’s weight, or if either parent or child has a disability causing dietary or exercise restrictions.

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random numbers table from Ettons Tables textbook
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
Recruiting
Date of first participant enrolment
Anticipated
20/01/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1576 0
Government body
Name [1] 1576 0
Queensland Health, Golden Casket Working Wonders grant
Country [1] 1576 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
Country
Australia
Secondary sponsor category [1] 1384 0
Individual
Name [1] 1384 0
Kim LeGros
Address [1] 1384 0
Country [1] 1384 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3002 0
Gold Coast Hospital Ethics Committee-Gold Coast Health Service District
Ethics committee address [1] 3002 0
Ethics committee country [1] 3002 0
Australia
Date submitted for ethics approval [1] 3002 0
Approval date [1] 3002 0
Ethics approval number [1] 3002 0
200351

Summary
Brief summary
The aim is to develop/evaluate a group behavioural program for parents that targets overweight/obese children aged 3 to 10 years.

It is thought that participation will result in: reduced child BMI scores, reduced energy intake, reduced media viewing, increased activity levels; and reduced primary parent BMI scores. These changes are thought to be able to be maintained three months after treatment.

Parental participation will hopefully result in improved parenting behaviour. These will be indicated by improved scores on parental self report measures of consistency, sense of satisfaction/efficacy and inter-parental conflict.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27934 0
Address 27934 0
Country 27934 0
Phone 27934 0
Fax 27934 0
Email 27934 0
Contact person for public queries
Name 10516 0
Kim LeGros
Address 10516 0
23 LeMans Drive, Broadbeach, Gold Coast,
QLD 4218
Country 10516 0
Australia
Phone 10516 0
07 55261327
Fax 10516 0
07 55261328
Email 10516 0
[email protected]
Contact person for scientific queries
Name 1444 0
Kim LeGros
Address 1444 0
23 LeMans Drive, Broadbeach, Gold Coast,
QLD 4218
Country 1444 0
Australia
Phone 1444 0
07 55261327
Fax 1444 0
07 55261328
Email 1444 0
[email protected]

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.