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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00738634




Registration number
NCT00738634
Ethics application status
Date submitted
18/08/2008
Date registered
20/08/2008
Date last updated
20/07/2012

Titles & IDs
Public title
IN2SHAPE: A Study of Physical Activity and Depressive Symptoms in Adolescence
Scientific title
IN2SHAPE Intervention to Stay Healthy and Physical Everyday: A Randomised Controlled Trial for the Feasibility and Effectiveness of a Self-motivated Physical Activity Intervention on the Mental Health of Adolescents.
Secondary ID [1] 0 0
2008/008 HREC
Universal Trial Number (UTN)
Trial acronym
IN2SHAPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Self-motivated physical activity
Behaviour - Nutrition
Behaviour - Physical activity researcher contact

Experimental: Physical activity mediated - Self-motivated physical activity intervention
Materials mailed to participants

Active Comparator: Nutrition control - Nutrition attention-control arm.
Delivered by researcher.

Experimental: Physical activity researcher contact - Self-motivated physical activity intervention
Delivered by researcher.


Behaviour: Self-motivated physical activity
Components:
Physical activity education in the form of a brief booklet (double sided A4 page).
Physical activity motivation tips (one sided A4 page).
Pedometer
Monitoring chart
Online presentation of common obstacles and ways to overcome these obstacles

Behaviour: Nutrition
Components:
Nutrition education booklet (Double-sided A4 page)
Nutrition motivation tips (single-sided A4 page)
Nutrition monitoring chart
Online presentation of common obstacles and ways to overcome these obstacles

Behaviour: Physical activity researcher contact
Behavioral: Self-motivated physical activity
Components:
Physical activity education in the form of a brief booklet (double sided A4 page).
Physical activity motivation tips (one sided A4 page).
Pedometer
Monitoring chart
Online presentation of common obstacles and ways to overcome these obstacles
Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Depression as measured by the Centre for Epidemiological Studies-Depression Scale (CES-D)
Timepoint [1] 0 0
Baseline, 8 weeks and 4 month post-intervention follow-up
Primary outcome [2] 0 0
Physical activity levels
Timepoint [2] 0 0
Baseline, 8 weeks and 4 month post-intervention follow-up
Secondary outcome [1] 0 0
Anxiety (RCMAS)
Timepoint [1] 0 0
Baseline, 8 weeks, and 4 month post-intervention follow-up

Eligibility
Key inclusion criteria
- Adolescents from Grades 7-10 (high school) and their parents/guardians.

- Adolescents scoring in the middle range (14-30) on the Centre for Epidemiological
Studies-Depression Scale (possible range 0-60).
Minimum age
11 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Adolescents currently engaging in 60+ minutes of physical activity per day.

- Adolescents who have experienced psychosis, schizophrenia or bipolar disorder.

- Adolescents who score >30 on the CES-D (indicator of severe depression).

- Adolescents who have physical health problems or conditions which preclude them from
participation in regular physical activity.

- Lack of written consent from adolescent and/or parent guardian.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2010
Sample size
Target
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 0 0
The Centre for Mental Health Research - Canberra
Recruitment postcode(s) [1] 0 0
0200 - Canberra

Funding & Sponsors
Primary sponsor type
Other
Name
Australian National University
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to determine whether physical activity prevents development of
depressive symptoms in adolescents.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00738634
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jacqueline L Brewer, BPsyc Hons
Address 0 0
The Australian National University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00738634