Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000119594
Ethics application status
Approved
Date submitted
16/02/2006
Date registered
4/04/2006
Date last updated
4/04/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Healthy Eating and Activity through Positive Parenting - the HELPP trial
Scientific title
A randomised phase IV study to evaluate the effectiveness of a parent-led family focussed lifestyle intervention on BMI z score in overweight children
Universal Trial Number (UTN)
Trial acronym
HELPP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child overweight 1084 0
Condition category
Condition code
Diet and Nutrition 1164 1164 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parenting skills training alone (6 month intervention); Parenting skills training with intensive lifestyle education (6 month intervention)
Intervention code [1] 900 0
Lifestyle
Comparator / control treatment
Wait-listed control (12 months)
Control group
Active

Outcomes
Primary outcome [1] 1569 0
Body Mass Index adjusted for age and gender and expressed as a standard deviation score (ie BMI Z score)
Timepoint [1] 1569 0
At 12 months
Secondary outcome [1] 2827 0
Waist circumference
Timepoint [1] 2827 0
Measured at baseline, 6, 12 and 18 months.
Secondary outcome [2] 2828 0
Fasting lipids, triglyceride, insulin, and glucose
Timepoint [2] 2828 0
Measured at baseline, 6, 12 and 18 months.
Secondary outcome [3] 2829 0
Blood pressure
Timepoint [3] 2829 0
Measured at baseline, 6, 12 and 18 months.
Secondary outcome [4] 2830 0
Health related quality of life
Timepoint [4] 2830 0
Measured at baseline, 6, 12 and 18 months.
Secondary outcome [5] 2831 0
Body satisfaction
Timepoint [5] 2831 0
Measured at baseline, 6, 12 and 18 months.
Secondary outcome [6] 2832 0
Parental weight status and waist circumference
Timepoint [6] 2832 0
Measured at baseline, 6, 12 and 18 months.
Secondary outcome [7] 2833 0
Eating and activity behaviours
Timepoint [7] 2833 0
Measured at baseline, 6, 12 and 18 months.
Secondary outcome [8] 2834 0
Parenting competency
Timepoint [8] 2834 0
Measured at baseline, 6, 12 and 18 months.
Secondary outcome [9] 2835 0
Parental satisfaction.
Timepoint [9] 2835 0
Measured at baseline, 6, 12 and 18 months.

Eligibility
Key inclusion criteria
Minimum age
6 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

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)
independently generated sequence, numbered sealed envelope opened by subejct on completion of baseline measures
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomization, total number per schedule variable
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
126
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1272 0
Commercial sector/Industry
Name [1] 1272 0
Australian Health Management Group Medical Research Fund
Country [1] 1272 0
Australia
Funding source category [2] 1273 0
Government body
Name [2] 1273 0
NHMRC PhD scholarship
Country [2] 1273 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 1127 0
None
Name [1] 1127 0
na
Address [1] 1127 0
Country [1] 1127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2603 0
Flinders University
Ethics committee address [1] 2603 0
Ethics committee country [1] 2603 0
Australia
Date submitted for ethics approval [1] 2603 0
Approval date [1] 2603 0
11/03/2002
Ethics approval number [1] 2603 0
2002.032
Ethics committee name [2] 2604 0
Women's and Children's Hospital
Ethics committee address [2] 2604 0
Ethics committee country [2] 2604 0
Australia
Date submitted for ethics approval [2] 2604 0
Approval date [2] 2604 0
29/05/2002
Ethics approval number [2] 2604 0
1312/4/2050

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35449 0
Address 35449 0
Country 35449 0
Phone 35449 0
Fax 35449 0
Email 35449 0
Contact person for public queries
Name 10089 0
Dr Anthea Magarey
Address 10089 0
Department of Nutrition and Dietetics
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 10089 0
Australia
Phone 10089 0
+61 8 82046304
Fax 10089 0
+61 8 82046406
Email 10089 0
[email protected]
Contact person for scientific queries
Name 1017 0
Dr Anthea Magarey
Address 1017 0
Department of Nutrition and Dietetics
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 1017 0
Australia
Phone 1017 0
+61 8 82046304
Fax 1017 0
+61 8 82046406
Email 1017 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.