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IN2SHAPE: A Study of Physical Activity and Depressive Symptoms in Adolescence (IN2SHAPE)

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ClinicalTrials.gov Identifier: NCT00738634
Recruitment Status : Completed
First Posted : August 20, 2008
Last Update Posted : July 20, 2012
Sponsor:
Information provided by (Responsible Party):
Jacqui Brewer, Australian National University

Tracking Information
First Submitted Date  ICMJE August 18, 2008
First Posted Date  ICMJE August 20, 2008
Last Update Posted Date July 20, 2012
Study Start Date  ICMJE July 2008
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2012)
  • Depression as measured by the Centre for Epidemiological Studies-Depression Scale (CES-D) [ Time Frame: Baseline, 8 weeks and 4 month post-intervention follow-up ]
  • Physical activity levels [ Time Frame: Baseline, 8 weeks and 4 month post-intervention follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
Depression as measured by the Centre for Epidemiological Studies-Depression Scale (CES-D) [ Time Frame: Baseline, 8 weeks and 6 month follow-up ]
Change History Complete list of historical versions of study NCT00738634 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2012)
Anxiety (RCMAS) [ Time Frame: Baseline, 8 weeks, and 4 month post-intervention follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2008)
  • Physical activity levels [ Time Frame: Baseline, 8 weeks and 6 month follow-up ]
  • Anxiety [ Time Frame: Baseline, 8 weeks, and 6 month follow-up ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IN2SHAPE: A Study of Physical Activity and Depressive Symptoms in Adolescence
Official Title  ICMJE 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.
Brief Summary The purpose of this study is to determine whether physical activity prevents development of depressive symptoms in adolescents.
Detailed Description

The primary objective of the project is to establish whether increasing physical activity can promote mental well-being in adolescents who are already displaying some depressive symptoms.

A further objective is to evaluate the feasibility of a novel self-motivated physical activity intervention, which has been designed for this project.

The final objective of this project is to investigate alternative intervention delivery modes, for an adolescent sample with subclinical depressive symptomatology, i.e., presenting with some depression symptoms but not at a level where major depressive disorder would be diagnosed. We aim to compare the effect of a completely mediated delivery approach for physical activity (i.e., no researcher contact) and a mediated intervention with face-to-face contact and fortnightly check-in telephone calls.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Depression
Intervention  ICMJE
  • 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
  • Behavioral: Nutrition

    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: Physical activity researcher contact

    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
Study Arms  ICMJE
  • Experimental: Physical activity mediated

    Self-motivated physical activity intervention

    Materials mailed to participants

    Intervention: Behavioral: Self-motivated physical activity
  • Active Comparator: Nutrition control

    Nutrition attention-control arm.

    Delivered by researcher.

    Intervention: Behavioral: Nutrition
  • Experimental: Physical activity researcher contact

    Self-motivated physical activity intervention

    Delivered by researcher.

    Intervention: Behavioral: Physical activity researcher contact
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 13, 2011)
26
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2008)
200
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date April 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 11 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00738634
Other Study ID Numbers  ICMJE 2008/008 HREC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jacqui Brewer, Australian National University
Study Sponsor  ICMJE Australian National University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Australian National University
Verification Date July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP