Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000120572
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
Parenting Eating and Activity for Child Health
Scientific title
A randomised phase IV trial to evaluate the effectiveness of a family focussed lifestyle program on BMI z score in overweight children
Universal Trial Number (UTN)
Trial acronym
PEACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child overweight 1085 0
Condition category
Condition code
Diet and Nutrition 1165 1165 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parenting skills training with intensive lifestyle education (6 months)
Intervention code [1] 901 0
Lifestyle
Comparator / control treatment
Intensive lifestyle education alone (6months)
Control group
Active

Outcomes
Primary outcome [1] 1570 0
Body Mass Index adjusted for age and gender and expressed as a standard deviation score (ie BMI Z score)
Timepoint [1] 1570 0
At 12 months
Secondary outcome [1] 2836 0
Waist circumference
Timepoint [1] 2836 0
12 months
Secondary outcome [2] 2837 0
Fasting lipids, triglyceride, insulin, and glucose
Timepoint [2] 2837 0
12 months
Secondary outcome [3] 2838 0
Blood pressure
Timepoint [3] 2838 0
12 months
Secondary outcome [4] 2839 0
Health related quality of life
Timepoint [4] 2839 0
12 months
Secondary outcome [5] 2840 0
Body satisfaction
Timepoint [5] 2840 0
12 months
Secondary outcome [6] 2841 0
Parenting
Timepoint [6] 2841 0
12 months
Secondary outcome [7] 2842 0
Parental BMI
Timepoint [7] 2842 0
12 months
Secondary outcome [8] 2843 0
Eating and activity behaviours
Timepoint [8] 2843 0
12 months
Secondary outcome [9] 2844 0
Health belief
Timepoint [9] 2844 0
12 months
Secondary outcome [10] 2845 0
Program satisfaction.
Timepoint [10] 2845 0
12 months

Eligibility
Key inclusion criteria
Overweight, pre-pubertal, caregiver able to attend sessions and read and understand English.
Minimum age
5 Years
Maximum age
9 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
BMI Z score > 4.0, syndromal obesity, medications influencing weight gain/loss, physical/developmental disability, chronic illness , significant dietary restriction, sibling enrolled.

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 schedule, numbered sealed envelope opened by subjects on completion of baseline measurements
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
random computer numbers
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
13/05/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
168
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1274 0
Government body
Name [1] 1274 0
NHMRC
Country [1] 1274 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 1128 0
Hospital
Name [1] 1128 0
The Children's Hospital Westmead
Address [1] 1128 0
Country [1] 1128 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2605 0
Flinders University
Ethics committee address [1] 2605 0
Ethics committee country [1] 2605 0
Australia
Date submitted for ethics approval [1] 2605 0
Approval date [1] 2605 0
22/12/2003
Ethics approval number [1] 2605 0
82/034
Ethics committee name [2] 2606 0
The Children's Hospital at Westmead
Ethics committee address [2] 2606 0
Ethics committee country [2] 2606 0
Australia
Date submitted for ethics approval [2] 2606 0
Approval date [2] 2606 0
06/05/2004
Ethics approval number [2] 2606 0
2004/013

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

Contacts
Principal investigator
Name 35951 0
Address 35951 0
Country 35951 0
Phone 35951 0
Fax 35951 0
Email 35951 0
Contact person for public queries
Name 10090 0
Dr Anthea Magarey
Address 10090 0
Department of Nutrition & Dietetics
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 10090 0
Australia
Phone 10090 0
+61 8 82046304
Fax 10090 0
+61 8 82046406
Email 10090 0
[email protected]
Contact person for scientific queries
Name 1018 0
Dr Anthea Magarey
Address 1018 0
Department of Nutrition & Dietetics
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 1018 0
Australia
Phone 1018 0
+61 8 82046304
Fax 1018 0
+61 8 82046406
Email 1018 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.