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Trial registered on ANZCTR


Registration number
ACTRN12612000865819
Ethics application status
Approved
Date submitted
9/08/2012
Date registered
16/08/2012
Date last updated
3/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Trial Of A Brief Lifestyle Parenting Intervention: Lifestyle Triple P Seminar Series
Scientific title
Effect of a brief lifestyle parenting intervention for parents of children aged 3 to 10 years on child weight status, child lifestyle and general behaviours, and parenting outcomes: Lifestyle Triple P Seminar Series.
Secondary ID [1] 280982 0
Nil
Universal Trial Number (UTN)
U1111-1133-3155
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood obesity 287100 0
Child health promotion 287101 0
Condition category
Condition code
Public Health 287425 287425 0 0
Health promotion/education
Diet and Nutrition 287426 287426 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Positive Parenting for Healthy Living Seminar Series (Lifestyle Triple P Seminar Series) is a new, brief adaptation of the Level Four Group Lifestyle Triple P program. It aims to help parents raise healthy children by providing them with information and practical strategies for positive parenting, promoting healthy eating, and increasing physical activity.

Parents attend a total of three parent sessions delivered over 3 consecutive weeks. Each session lasts 90 minutes, and is delivered in group format to parents. Parents must attend all three sessions. Both parents and other caregivers are encouraged to attend the program, however one parent need only attend for a family to be eligible for the trial.
Intervention code [1] 285425 0
Lifestyle
Intervention code [2] 285426 0
Behaviour
Comparator / control treatment
No treatment -care as usual. The study will experimentally test the relative impact of Lifestyle Triple P against care as usual in improving both general and lifestyle-specific child and parenting outcomes.
Control group
Active

Outcomes
Primary outcome [1] 290648 0
The Parenting Scale (Arnold et al., 1993).
Timepoint [1] 290648 0
Baseline (upon entry and before randomisation), 6 weeks later, 6 months later, and 12 months later.
Primary outcome [2] 290649 0
The Lifestyle Parenting Questionnaire (LPQ) -recently developed by Bartlett and Sanders (2012)
Timepoint [2] 290649 0
Baseline (upon entry and before randomisation), 6 weeks later, 6 months later, and 12 months later.
Primary outcome [3] 290650 0
The Lifestyle Behaviour Checklist (West & Sanders, 2009)
Timepoint [3] 290650 0
Baseline (upon entry and before randomisation), 6 weeks later, 6 months later, and 12 months later.
Secondary outcome [1] 298635 0
Accelerometers will be used to measure the amount and intensity of child physical activity (model: GT3X plus). Accelerometers are waterproof, small (4.6 cm x 3.3 cm x 1.5 cm), lightweight (19 grams) and unobtrusive. Accelerometers will be worn on the child's right hip via an adjustable waist belt as placement here has been found to be more valid and less obtrusive (McIver et al., 2005; Ward et al., 2005). Children will be asked to wear an accelerometer from morning wakening until bedtime for seven consecutive days. Accelerometers will be worn during bathing and swimming. Parents will complete an accompanying activity chart.
Timepoint [1] 298635 0
Baseline (upon entry and before randomisation), 6 weeks later, 6 months later, and 12 months later.
Secondary outcome [2] 298636 0
A 3-day food diary will be used to measure the child's diet. Parents will be asked to monitor their child's food and drink intake for three days (i.e., two week days and 1 weekend day). They will be asked to record the type and quantity of all foods and drinks the child consumes for the three days. Food data will be analysed using nutrition software (Foodworks Professional, Xyris Software, Australia).
Timepoint [2] 298636 0
Baseline (upon entry and before randomisation), 6 weeks later, 6 months later, and 12 months later.
Secondary outcome [3] 298639 0
The Child Adjustment and Parent Efficacy Scale (CAPES; Morawska & Sanders, 2010)
Timepoint [3] 298639 0
Baseline (upon entry and before randomisation), 6 weeks later, 6 months later, and 12 months later.
Secondary outcome [4] 298640 0
Parent body mass index (BMI) will also be collected to assess parental weight status. Parent BMI will be obtained using the same procedures used for collecting child BMI. BMI will be classified as underweight, healthy weight, overweight, or obese using the Australian standard definitions (Australian Government Department of Health and Aging, 2002).
Timepoint [4] 298640 0
Baseline (upon entry and before randomisation), 6 weeks later, 6 months later, and 12 months later.
Secondary outcome [5] 304979 0
Child body mass index. BMI will be expressed as measured weight in kilograms divided by measured height in meters squared (kg/m2). BMI scores will be converted into age and gender specific BMI z scores using the least mean square (LMS) reference parameters provided by the United States Centres for Disease Control (CDC 2000). Child height and weight recordings will be measured objectively using a stadiometer and scales, and under standard procedures (Davies et al., 2000).
Timepoint [5] 304979 0
Baseline (upon entry and before randomisation), 6 weeks later, 6 months later, and 12 months later.
Secondary outcome [6] 304980 0
Child weight which will be objectively measured using scales according to the protocol outlined by Davies et al (2000).
Timepoint [6] 304980 0
Baseline (upon entry and before randomisation), 6 weeks later, 6 months later, and 12 months later.
Secondary outcome [7] 304981 0
Child waist circumference will also be used to evaluate child truncal adiposity. A reduction in waist circumference in a child could indicate a loss of central fat.
Timepoint [7] 304981 0
Baseline (upon entry and before randomisation), 6 weeks later, 6 months later, and 12 months later.

Eligibility
Key inclusion criteria
- Child aged 3 to 10 years inclusive
- Parent can attend all three 90 minute parent sessions
Minimum age
3 Years
Maximum age
10 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Child diagnosed with a severe developmental delay, intellectual or physical disability, or chronic illness. - Child is currently consulting another professional for child behaviour difficulties or emotional problems. - Child is taking any long-term medication that affects growth or weight control (including inhaled or oral steroids, anti-epileptics or other). - Child is currently consulting a dietician for the child’s weight management. - Parent foresees major disruptions in the next 12 months that make it difficult for parents to complete the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to intervention is concealed. Parents are allocated following completion of the baseline assessment phase. Allocation involves contacting the holder of the allocation schedule who is at central administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by a computer software program (i.e., computerised sequence generation using Research Randomiser).

Assessors will be blinded to initial allocation.
Masking / blinding
Open (masking not 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
Recruiting
Date of first participant enrolment
Anticipated
31/07/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
153
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285779 0
University
Name [1] 285779 0
Parenting and Family Support Centre, University of Queensland
Country [1] 285779 0
Australia
Primary sponsor type
University
Name
Parenting and Family Support Centre, University of Queensland
Address
Parenting and Family Support Centre
School of Psychology
University of Queensland
St Lucia, Brisbane QLD 4072
Country
Australia
Secondary sponsor category [1] 284602 0
None
Name [1] 284602 0
Address [1] 284602 0
Country [1] 284602 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287788 0
Behavioural & Social Sciences Ethical Review Committee
Ethics committee address [1] 287788 0
Ethics committee country [1] 287788 0
Date submitted for ethics approval [1] 287788 0
Approval date [1] 287788 0
21/03/2012
Ethics approval number [1] 287788 0
2012000219

Summary
Brief summary
This evaluation trial will evaluate a brief parent Lifestyle Triple P Seminar program for parents of overweight children aged 3 – 10 years of age in a randomised trial comparing the parenting intervention against care as usual. The CONSORT guidelines for randomised controlled trials will be utilised. The study is a 2 (Triple P vs case as usual) x 4 (time: pre-test, post-test, 6-month follow up, and 12-month follow up) design. The study will experimentally test the relative impact of Triple P against care as usual in improving both general and lifestyle-specific child and parenting outcomes. The trial is recruiting all over Brisbane and Ipswich suburbs.
Trial website
www.exp.psy.uq.edu.au/life
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34543 0
Miss Jessica Bartlett
Address 34543 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
St Lucia, QLD 4072
AUSTRALIA
Country 34543 0
Australia
Phone 34543 0
+61(7) 3103 3395
Fax 34543 0
+61 (7) 3365 6724
Email 34543 0
[email protected]
Contact person for public queries
Name 17790 0
Miss Jess Bartlett
Address 17790 0
Lifestyle Triple P Seminar Project
Parenting and Family Support Centre
School of Psychology
University of Queensland
St Lucia, Brisbane QLD 4072
Country 17790 0
Australia
Phone 17790 0
+61 7 3103 3395
Fax 17790 0
Email 17790 0
[email protected]
Contact person for scientific queries
Name 8718 0
Miss Jess Bartlett
Address 8718 0
Lifestyle Triple P Seminar Project
Parenting and Family Support Centre
School of Psychology
University of Queensland
St Lucia, Brisbane QLD 4072
Country 8718 0
Australia
Phone 8718 0
+61 7 3103 3395
Fax 8718 0
Email 8718 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

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