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Trial registered on ANZCTR


Registration number
ACTRN12611001187932
Ethics application status
Approved
Date submitted
15/11/2011
Date registered
15/11/2011
Date last updated
14/04/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Among overweight adolescents, does a community based program (Curtin Activity, Food and Attitudes Program) lead to improved activity and food behaviours?
Scientific title
Among overweight adolescents, does a community based family centred multidisciplinary program (Curtin Activity, Food and Attitudes Program) lead to improved activity and food behaviours?
Secondary ID [1] 273348 0
None
Universal Trial Number (UTN)
Trial acronym
CAFAP2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
obesity 279116 0
Condition category
Condition code
Public Health 279308 279308 0 0
Health promotion/education
Physical Medicine / Rehabilitation 279309 279309 0 0
Physiotherapy
Diet and Nutrition 279310 279310 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intensive 8 week period involving twice weekly sessions of 2 hours duration followed by 12 weeks of maintenance contact.

On entry into the study participants will be assessed and be placed on a waitlist for 8-12weeks before being assessed again prior to starting the intensive 8 week program. This waitlist period will provide a within-subject control period. Participants will be assessed at the end of the 8 week intensive program and again after 3, 6 and 12 months. Cohorts of 10-15 adolescents (along with a parent for each) will be recruited in 2-3 geographical regions with multiple cohorts in each region. The staggered start to the multiple cohorts in each region provides a control over major external events.

The intensive program involves 1 hour of exercise and 1 hour education and support twice weekly for adolescents. Exercises include aerobic, strength, power and endurance stations and are performed in a group setting administered by a physiotherapist. Education and support covers activity, food and attitudes. Activity intervention includes education to improve moderate/vigorous physical activity, light activity and sedentary behaviours. Food intervention includes education to improve healthy eating behaviours. Attitude intervention includes goal setting, problem solving, affect regulation. Education sessions are administered in a group setting by one of the physiotherapy, nutrition, social work or psychology facilitators.

The intensive program includes 2 hours of education and support for parents of the adolescents. Some sessions are combined with adolescents. Other sessions include 'walk and talk' informal support, supermarket buying skills, snack and meal preparation skills, providing autonomy support for adolescents.

The 2 hour twice weekly adolescent and parent sessions during the intensive phase occur concurrently, with some joint education sessions.

The 3 month maintenance program includes several reminders and review of goal setting each week using information technologies (phone, SMS, email, web) and occaisonal group meetings.
Intervention code [1] 283692 0
Lifestyle
Intervention code [2] 283732 0
Rehabilitation
Comparator / control treatment
Within subjects study, with waitlist period as the active comparator and staggered start of 3 cohorts followed to 12 months post-intevention
Control group
Active

Outcomes
Primary outcome [1] 279922 0
Physical activity assessed by accelerometer (time in sedentary, light and moderate/vigorous activity)
Timepoint [1] 279922 0
study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
Primary outcome [2] 279923 0
Nutrition behaviour assessed by 3 day food diary (daily serves of fruit, vegetables, 'extras')
Timepoint [2] 279923 0
study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
Secondary outcome [1] 294780 0
Sedentary behaviours assessed by questionaire
Timepoint [1] 294780 0
study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
Secondary outcome [2] 294781 0
Nutrition behaviours assessed by questionnaire
Timepoint [2] 294781 0
study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
Secondary outcome [3] 294782 0
Physical status assessed by examination (BMI, waist and hip girth, cardiovascular fitness (modified shuttle walk test), muscle strength (quadriceps, biceps, deltoid manual break test), muscle power (vertical jump), muscle endurance (abdominal curls)
Timepoint [3] 294782 0
study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
Secondary outcome [4] 294783 0
Mental health assessed by Moods and Feelings questionnaire
Timepoint [4] 294783 0
study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
Secondary outcome [5] 294784 0
Quality of life assessed by Paediatric Quality of Life - Teen Report
Timepoint [5] 294784 0
study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
Secondary outcome [6] 294785 0
Autonomy support, structure and involvement (Perceived Autonomy Support Scales for Exercise Settings and Perceived Environmental Supportiveness Scale) and autonomous motivation (Revised Behavioural Regulations and Exercise Scale, Integrated Regulation Scale for Exercise Behaviour, and Percieved Locus of Causality for Dieting) for physical activity and healthy eating
Timepoint [6] 294785 0
study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
Secondary outcome [7] 294786 0
Parental mental health assessed by Depression Anxiety and Stress Scale
Timepoint [7] 294786 0
study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
Secondary outcome [8] 294787 0
Family functioning assessed by McMaster Family Assessment Device general functioning subscale
Timepoint [8] 294787 0
study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
Secondary outcome [9] 294788 0
Goal attainment and conflict assess by questionnaire
Timepoint [9] 294788 0
goal conflict will be assessed at study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
goal attainment will be collected each week during the intervention period (starting from middle of the intensive intervention period when goal setting is introduced) and at followups
Secondary outcome [10] 294789 0
Program evaluation using interviews with participants and facilitators
Timepoint [10] 294789 0
immediately post program and 12 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 as unsuitable 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
multiple cohort, staggered start, waitlist controlled, within subject design
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2011
Actual
30/01/2012
Date of last participant enrolment
Anticipated
Actual
4/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
96
Accrual to date
Final
69
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 284175 0
Government body
Name [1] 284175 0
Western Australian Health Promotion Foundation (Healthway)
Country [1] 284175 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
GPO Box U1987
Perth WA 6845
Country
Australia
Secondary sponsor category [1] 269129 0
None
Name [1] 269129 0
Address [1] 269129 0
Country [1] 269129 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286134 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 286134 0
Ethics committee country [1] 286134 0
Australia
Date submitted for ethics approval [1] 286134 0
Approval date [1] 286134 0
07/09/2011
Ethics approval number [1] 286134 0
HR105/2011

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

Contacts
Principal investigator
Name 33363 0
Prof Professor Leon Straker
Address 33363 0
School of Physiotherapy
Curtin University
GPO Box U1987
Perth WA 6845
Australia
Country 33363 0
Australia
Phone 33363 0
+61 8 9266 3634
Fax 33363 0
Email 33363 0
L.Straker@curtin.edu.au
Contact person for public queries
Name 16610 0
Professor Leon Straker
Address 16610 0
School of Physiotherapy
Curtin University
GPO Box U1987
Perth WA 6845
Country 16610 0
Australia
Phone 16610 0
+61 8 9266 3634
Fax 16610 0
+61 8 9266 3699
Email 16610 0
cafap@curtin.edu.au
Contact person for scientific queries
Name 7538 0
Professor Leon Straker
Address 7538 0
School of Physiotherapy
Curtin University
GPO Box U1987
Perth WA 6845
Country 7538 0
Australia
Phone 7538 0
+61 8 9266 3634
Fax 7538 0
+61 8 9266 3699
Email 7538 0
cafap@curtin.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseDo overweight adolescents adhere to dietary intervention messages? Twelve-month detailed dietary outcomes from curtin university's activity, food and attitudes program.2015https://dx.doi.org/10.3390/nu7064363
EmbaseRelationships between psychosocial outcomes in adolescents who are obese and their parents during a multi-disciplinary family-based healthy lifestyle intervention: One-year follow-up of a waitlist controlled trial (Curtin University's Activity, Food and Attitudes Program).2016https://dx.doi.org/10.1186/s12955-016-0501-z
N.B. These documents automatically identified may not have been verified by the study sponsor.