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

Depression Clinical Trial

— IN2SHAPE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00738634
• Other study ID #: 2008/008 HREC
• Status: Completed
• Phase: N/A
• First received: August 18, 2008
• Last updated: July 18, 2012
• Start date: July 2008
• Est. completion date: April 2010

Study information

• Verified date: July 2012
• Source: Australian National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 11 Years to 17 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Self-motivated physical activity
Components: Physical activity education in the form of a brief booklet (double sided A4 page). Physical activity motivation tips (one sided A4 page). Pedometer Monitoring chart Online presentation of common obstacles and ways to overcome these obstacles
• Nutrition
Components: Nutrition education booklet (Double-sided A4 page) Nutrition motivation tips (single-sided A4 page) Nutrition monitoring chart Online presentation of common obstacles and ways to overcome these obstacles
• Physical activity researcher contact
Behavioral: Self-motivated physical activity Components: Physical activity education in the form of a brief booklet (double sided A4 page). Physical activity motivation tips (one sided A4 page). Pedometer Monitoring chart Online presentation of common obstacles and ways to overcome these obstacles

Locations

Country	Name	City	State
Australia	The Centre for Mental Health Research	Canberra	Australian Capital Territory

Sponsors (1)

Lead Sponsor	Collaborator
Australian National University

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression as measured by the Centre for Epidemiological Studies-Depression Scale (CES-D)		Baseline, 8 weeks and 4 month post-intervention follow-up	No
Primary	Physical activity levels		Baseline, 8 weeks and 4 month post-intervention follow-up	No
Secondary	Anxiety (RCMAS)		Baseline, 8 weeks, and 4 month post-intervention follow-up	No