IN2SHAPE: A Study of Physical Activity and Depressive Symptoms in Adolescence
IN2SHAPE
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.
1 other identifier
interventional
26
1 country
1
Brief Summary
The purpose of this study is to determine whether physical activity prevents development of depressive symptoms in adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable depression
Started Jul 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 18, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJuly 20, 2012
July 1, 2012
1.8 years
August 18, 2008
July 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Depression as measured by the Centre for Epidemiological Studies-Depression Scale (CES-D)
Baseline, 8 weeks and 4 month post-intervention follow-up
Physical activity levels
Baseline, 8 weeks and 4 month post-intervention follow-up
Secondary Outcomes (1)
Anxiety (RCMAS)
Baseline, 8 weeks, and 4 month post-intervention follow-up
Study Arms (3)
Physical activity mediated
EXPERIMENTALSelf-motivated physical activity intervention Materials mailed to participants
Nutrition control
ACTIVE COMPARATORNutrition attention-control arm. Delivered by researcher.
Physical activity researcher contact
EXPERIMENTALSelf-motivated physical activity intervention Delivered by researcher.
Interventions
Components: 1. Physical activity education in the form of a brief booklet (double sided A4 page). 2. Physical activity motivation tips (one sided A4 page). 3. Pedometer 4. Monitoring chart 5. Online presentation of common obstacles and ways to overcome these obstacles
Components: 1. Nutrition education booklet (Double-sided A4 page) 2. Nutrition motivation tips (single-sided A4 page) 3. Nutrition monitoring chart 4. Online presentation of common obstacles and ways to overcome these obstacles
Behavioral: Self-motivated physical activity Components: 1. Physical activity education in the form of a brief booklet (double sided A4 page). 2. Physical activity motivation tips (one sided A4 page). 3. Pedometer 4. Monitoring chart 5. Online presentation of common obstacles and ways to overcome these obstacles
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Centre for Mental Health Research
Canberra, Australian Capital Territory, 0200, Australia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacqueline L Brewer, BPsyc Hons
The Australian National University
- STUDY CHAIR
Janine Walker, PhD
The Australian National University
- STUDY DIRECTOR
Prof Helen Christensen, PhD
The Australian National University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ms
Study Record Dates
First Submitted
August 18, 2008
First Posted
August 20, 2008
Study Start
July 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
July 20, 2012
Record last verified: 2012-07