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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jacqui Brewer, Australian National University
ClinicalTrials.gov Identifier:
NCT00738634
First received: August 18, 2008
Last updated: July 18, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to determine whether physical activity prevents development of depressive symptoms in adolescents.


Condition Intervention
Depression
 Behavioral: Self-motivated physical activity
Behavioral: Nutrition
Behavioral: Physical activity researcher contact

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Australian National University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Physical activity levels [ Time Frame: Baseline, 8 weeks and 4 month post-intervention follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety (RCMAS) [ Time Frame: Baseline, 8 weeks, and 4 month post-intervention follow-up ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: July 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Physical activity mediated

Self-motivated physical activity intervention

Materials mailed to participants

 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
Active Comparator: Nutrition control

Nutrition attention-control arm.

Delivered by researcher.

 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
Experimental: Physical activity researcher contact

Self-motivated physical activity intervention

Delivered by researcher.

 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

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.

  Eligibility

Ages Eligible for Study:   11 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00738634

Locations
Australia, Australian Capital Territory
The Centre for Mental Health Research
Canberra, Australian Capital Territory, Australia, 0200
Sponsors and Collaborators
Australian National University
Investigators
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
  More Information

No publications provided

Responsible Party: Jacqui Brewer, Ms, Australian National University
ClinicalTrials.gov Identifier: NCT00738634     History of Changes
Other Study ID Numbers: 2008/008 HREC
Study First Received: August 18, 2008
Last Updated: July 18, 2012
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Australian National University:
Depression
Motor Activity
Adolescent

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 21, 2013