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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?
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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?
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Secondary ID [1]
273348
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None
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Universal Trial Number (UTN)
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Trial acronym
CAFAP2
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
obesity
279116
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Condition category
Condition code
Public Health
279308
279308
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0
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Health promotion/education
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Physical Medicine / Rehabilitation
279309
279309
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0
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Physiotherapy
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Diet and Nutrition
279310
279310
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
283692
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Lifestyle
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Intervention code [2]
283732
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Rehabilitation
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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
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Control group
Active
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Outcomes
Primary outcome [1]
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Physical activity assessed by accelerometer (time in sedentary, light and moderate/vigorous activity)
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Assessment method [1]
279922
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Timepoint [1]
279922
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study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
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Primary outcome [2]
279923
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Nutrition behaviour assessed by 3 day food diary (daily serves of fruit, vegetables, 'extras')
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Assessment method [2]
279923
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Timepoint [2]
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study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
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Secondary outcome [1]
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Sedentary behaviours assessed by questionaire
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Assessment method [1]
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Timepoint [1]
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study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
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Secondary outcome [2]
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Nutrition behaviours assessed by questionnaire
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Assessment method [2]
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Timepoint [2]
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study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
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Secondary outcome [3]
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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)
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Assessment method [3]
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Timepoint [3]
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study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
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Secondary outcome [4]
294783
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Mental health assessed by Moods and Feelings questionnaire
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Assessment method [4]
294783
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Timepoint [4]
294783
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study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
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Secondary outcome [5]
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Quality of life assessed by Paediatric Quality of Life - Teen Report
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Assessment method [5]
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Timepoint [5]
294784
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study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
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Secondary outcome [6]
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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
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Assessment method [6]
294785
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Timepoint [6]
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study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
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Secondary outcome [7]
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Parental mental health assessed by Depression Anxiety and Stress Scale
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Assessment method [7]
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Timepoint [7]
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study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
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Secondary outcome [8]
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Family functioning assessed by McMaster Family Assessment Device general functioning subscale
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Assessment method [8]
294787
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Timepoint [8]
294787
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study entry (pre waitlist), pre program (post waitlist), immediately post program, 3, 6 and 12 months post program
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Secondary outcome [9]
294788
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Goal attainment and conflict assess by questionnaire
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Assessment method [9]
294788
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Timepoint [9]
294788
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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
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Secondary outcome [10]
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Program evaluation using interviews with participants and facilitators
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Assessment method [10]
294789
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Timepoint [10]
294789
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immediately post program and 12 months post program
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Eligibility
Key inclusion criteria
body mass index > 85th percentile
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Minimum age
11
Years
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Maximum age
16
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
obesity due to identified genetic, metabolic, endocrine disease; psychiatric disorder; medic assessed as unsuitable to participate
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
multiple cohort, staggered start, waitlist controlled, within subject design
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Phase
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/12/2011
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Actual
30/01/2012
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Date of last participant enrolment
Anticipated
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Actual
4/09/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
96
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Accrual to date
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Final
69
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
284175
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Government body
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Name [1]
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Western Australian Health Promotion Foundation (Healthway)
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Address [1]
284175
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PO Box 1284
West Perth WA 6872
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Country [1]
284175
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Australia
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Primary sponsor type
University
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Name
Curtin University
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Address
GPO Box U1987
Perth WA 6845
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Country
Australia
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Secondary sponsor category [1]
269129
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None
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Name [1]
269129
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Address [1]
269129
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Country [1]
269129
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
286134
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Curtin University Human Research Ethics Committee
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Ethics committee address [1]
286134
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GPO Box U1987 Perth WA 6845
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Ethics committee country [1]
286134
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Australia
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Date submitted for ethics approval [1]
286134
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Approval date [1]
286134
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07/09/2011
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Ethics approval number [1]
286134
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HR105/2011
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Summary
Brief summary
This study aims to help overweight adolescents develop healthy activity, food and attitude habits. Adolescents and their parents participate in an intensive 8 week program (involving twice weekly 2 hour sessions) followed by regular contact for 3 months to assist with goal achievement. The study hypothesis is that adolescent activity and food behaviours will be improved after the intensive program and be maintained at 12 months post program
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Trial website
cafap.curtin.edu.au
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Trial related presentations / publications
Straker, L., Smith, K., Fenner, A., Kerr, D., McManus, A., Davis, M. Fielding, A., Olds, T., Hagger, M., Smith, A. &. Abbott, R. (2012). Rationale, design and methods for a staggered-entry, waitlist controlled clinical trial of the impact of a community-based, family-centred, multidisciplinary program focused on activity, food and attitude habits (Curtin University's Activity, Food and Attitudes Program-CAFAP) among overweight adolescents. BMC Public Health, 12, 471. Fenner, A., Hagger, M., & Straker, L. (2013). Theoretical underpinnings of a need-supportive intervention to address sustained healthy lifestyle changes in overweight and obese adolescents. Psychology of Sport and Exercise, 14, 819-829. Straker, L., E. Howie, K. Smith, A. Fenner, D. Kerr, T. Olds, R. Abbott and A. Smith (2014). "Curtin University's Activity, Food and Attitudes Program improves physical activity, sedentary time and healthy eating among overweight and obese adolescents: A waitlist controlled trial." PlosOne 9(11): e111954. Smith, K., Kerr, D., Howie, E., & Straker, L. (2015). Do overweight adolescents adhere to dietary intervention messages? Twelve month detailed dietary outcomes from Curtin University's Activity, Food and Attitudes Program. Nutrients, 7, 4363-4382. Smith, K., L. Straker, D. Kerr & A. Smith (2015). Obese adolescents eat what? And when? Detailed consumption patterns provide targets for intervention goal setting. Journal of Human Nutrition and Dietetics 28(s2): 80-93. Howie, E., McVeigh, J., Abbott, R., Olds, T., & Straker, L. (in press (accepted 18th Nov 2015)). Multiple components of fitness improved among overweight and obese adolescents up to one year following a community-based lifestyle intervention. Journal of Sports Science. Howie, E., Olds, T., McVeigh, J., Abbott, R., & Straker, L. (in press (accepted 11 Jan 2015)). It's a-bout time: Detailed patterns of physical activity in obese adolescents participating in a lifestyle intervention. Journal of Physical Activity and Health. Smith, K., Kerr, D., Howie, E., & Straker, L. (2015). Do overweight adolescents adhere to dietary intervention messages? Twelve month detailed dietary outcomes from Curtin University's Activity, Food and Attitudes Program. Nutrients, 7, 4363-4382. Fenner, A., Howie, E., Hagger, M., & Straker, L. (in press (accepted 6th Dec 2015)). Exploration of the mechanisms of change in constructs from Self-Determination Theory and quality of life during a multi-disiplinary family-based intervention for overweight adolescents. Journal of Sport and Exercise Psychology. Smith, K., L. Straker, A. McManus and †A. Fenner (2014). Barriers and enablers for participation in healthy lifestyle programs by adolescents who are overweight: A qualitative study of the opinions of adolescents, their parents and community stakeholders. BMC Paediatrics 14: 53. Smith, K., D. Kerr, A. Fenner and L. Straker (2014). Adolescents just don't know what they want: a qualitative study to describe obese adolescents' experiences of text messaging to support behaviour change maintenance post intervention. Journal of Medical Internet Research 16(4): e103.
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Public notes
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Contacts
Principal investigator
Name
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Prof Professor Leon Straker
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Address
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School of Physiotherapy
Curtin University
GPO Box U1987
Perth WA 6845
Australia
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Country
33363
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Australia
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Phone
33363
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+61 8 9266 3634
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Fax
33363
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Email
33363
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[email protected]
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Contact person for public queries
Name
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Professor Leon Straker
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Address
16610
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School of Physiotherapy
Curtin University
GPO Box U1987
Perth WA 6845
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Country
16610
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Australia
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Phone
16610
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+61 8 9266 3634
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Fax
16610
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+61 8 9266 3699
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Email
16610
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[email protected]
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Contact person for scientific queries
Name
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Professor Leon Straker
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Address
7538
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School of Physiotherapy
Curtin University
GPO Box U1987
Perth WA 6845
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Country
7538
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Australia
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Phone
7538
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+61 8 9266 3634
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Fax
7538
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+61 8 9266 3699
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Email
7538
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Do overweight adolescents adhere to dietary intervention messages? Twelve-month detailed dietary outcomes from curtin university's activity, food and attitudes program.
2015
https://dx.doi.org/10.3390/nu7064363
Embase
Relationships 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).
2016
https://dx.doi.org/10.1186/s12955-016-0501-z
N.B. These documents automatically identified may not have been verified by the study sponsor.
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