Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000280202
Ethics application status
Approved
Date submitted
9/03/2009
Date registered
15/05/2009
Date last updated
14/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Amoung obese adolescents, does a multidisciplinary intervention (Curtin Activity, Food and Attitudes program) lead to improved mental health status?
Scientific title
Among obese adolescents, does a multidisciplinary intervention program, incorporating physical, mental and nutritional initiatives, lead to improved mental health status?
Secondary ID [1] 259980 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 4442 0
Condition category
Condition code
Public Health 4711 4711 0 0
Health promotion/education
Mental Health 237075 237075 0 0
Studies of normal psychology, cognitive function and behaviour
Diet and Nutrition 237076 237076 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 week multidisciplinary program involving twice weekly 1 hour exercise classes and twice weekly 1 hour physical activity, sedentary activity, nutrition and mental health education and group counselling for adolescents and twice weekly 2 hour education and group counselling for parents.

Exercise sessions for adolescents

Exercise classes involve aerobic, strength and coordination stations and adolescents participate twice a week for 1 hour duration on each occasion.

Education sessions for adolescents and parents

Activity intervention includes education to increase participation in moderate and vigorous physical activity including mapping of community resource opportunities. Also includes education on reduction of screen based sendentary behaviours.
Food intervention includes education about healthy eating principles, energy balance, supermarket buying skills, sensory perception, snack and meal preparation skills and the influence of media.
Attitude intervention includes readiness to change, goal setting, affect regulation, mindfulness, helpful thinking and problem solving.
Adolescents attend education sessions twice weekly for one hour duration on each occaision.
Parents attend twice weekly and receive similar education sessions - sometimes with adolescents and sometimes independantly. Parents also participate in weekly 'walk and talk' informal discussion and problem solving sessions.
All intervention is in groups except for social worker visits to each family.
Intervention code [1] 4188 0
Lifestyle
Comparator / control treatment
no comparision group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5578 0
mental health will be assessed by the 'moods and feelings' questionnaire
Timepoint [1] 5578 0
immediately post program and at 3 and 6 months post program
Secondary outcome [1] 9402 0
physical activity will be assessed by 7 day accelerometry
Timepoint [1] 9402 0
immediately post program and at 3 and 6 months post program
Secondary outcome [2] 9403 0
sedentary behaviours will be assessed by frequency and duration of exposure to various sedentary behaviours questionnaire
Timepoint [2] 9403 0
immediately post program and at 3 and 6 months post program
Secondary outcome [3] 9404 0
nutrition behaviours will be assessed by 3 day food diary
Timepoint [3] 9404 0
immediately post program and at 3 and 6 months post program
Secondary outcome [4] 9405 0
adiposity will be assessed by body mass index (BMI), waist girth and dual x-ray densiometry DXA determined % body fat
Timepoint [4] 9405 0
immediately post program and at 3 and 6 months post program

Eligibility
Key inclusion criteria
body mass index > 85th percentile
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
obesity due to identified genetic, metabolic, endocrine disease;
psychiatric disorder;
medic assessed unsafe to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
all participants complete the intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/07/2009
Actual
16/04/2009
Date of last participant enrolment
Anticipated
Actual
1/06/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 4634 0
Self funded/Unfunded
Name [1] 4634 0
Country [1] 4634 0
Primary sponsor type
University
Name
Curtin University of Technology
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 4178 0
None
Name [1] 4178 0
Address [1] 4178 0
Country [1] 4178 0
Other collaborator category [1] 605 0
Hospital
Name [1] 605 0
Princess Margaret Hospital for Children
Address [1] 605 0
Roberts Road
Subiaco
WA 6008
Country [1] 605 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6672 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 6672 0
Ethics committee country [1] 6672 0
Australia
Date submitted for ethics approval [1] 6672 0
04/05/2009
Approval date [1] 6672 0
11/09/2009
Ethics approval number [1] 6672 0
HR92/2009

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

Contacts
Principal investigator
Name 29370 0
Prof Leon Straker
Address 29370 0
School of Physiotherapy and Exercise Science
Curtin University
GPO Box U1987
Perth, WA 6845
Country 29370 0
Australia
Phone 29370 0
+61 8 9266 3634
Fax 29370 0
Email 29370 0
[email protected]
Contact person for public queries
Name 12617 0
Professor Leon Straker
Address 12617 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth WA 6845
Country 12617 0
Australia
Phone 12617 0
+61 8 9266 3634
Fax 12617 0
Email 12617 0
[email protected]
Contact person for scientific queries
Name 3545 0
Professor Leon Straker
Address 3545 0
School of Physiotherapy
Curtin University of Technology
GPO Box U1987
Perth WA 6845
Country 3545 0
Australia
Phone 3545 0
+61 8 9266 3634
Fax 3545 0
Email 3545 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.