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Clinical Trials/NCT00738634
NCT00738634CompletedNot Applicable

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.

Australian National University2 sites in 1 country26 target enrollmentStarted: July 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
2
Primary Endpoint
Depression as measured by the Centre for Epidemiological Studies-Depression Scale (CES-D)

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
11 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Anxiety (RCMAS)(Baseline, 8 weeks, and 4 month post-intervention follow-up)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jacqui Brewer

Ms

Australian National University

Study Sites (2)

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