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

July 18, 2012 updated by: Jacqui Brewer, Australian National University

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia, 0200
        • The Centre for Mental Health Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Baseline, 8 weeks and 4 month post-intervention follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Anxiety (RCMAS)
Time Frame: Baseline, 8 weeks, and 4 month post-intervention follow-up
Baseline, 8 weeks, and 4 month post-intervention follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

August 18, 2008

First Submitted That Met QC Criteria

August 18, 2008

First Posted (Estimate)

August 20, 2008

Study Record Updates

Last Update Posted (Estimate)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 18, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008/008 HREC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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