Clinical trial NCT00738634: IN2SHAPE: A Study of Physical Activity and Depressive Symptoms in Adolescence
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Motor Activity
Adolescent
Lead sponsor: Australian National University
Sponsor class: OTHER
First posted: 2008-08-20
Enrollment: 26
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Depression as measured by the Centre for Epidemiological Studies-Depression Scale (CES-D)
timeFrame: Baseline, 8 weeks and 4 month post-intervention follow-up
measure: Physical activity levels
timeFrame: Baseline, 8 weeks and 4 month post-intervention follow-up
Secondary outcomes:
measure: Anxiety (RCMAS)
timeFrame: Baseline, 8 weeks, and 4 month post-intervention follow-up
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: The Centre for Mental Health Research
state: Australian Capital Territory
Study officials:
affiliation: The Australian National University
name: Jacqueline L Brewer, BPsyc Hons
role: PRINCIPAL_INVESTIGATOR
affiliation: The Australian National University
name: Janine Walker, PhD
role: STUDY_CHAIR
affiliation: The Australian National University
name: Prof Helen Christensen, PhD
role: STUDY_DIRECTOR
References: