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Completed

NCT Number: NCT00738634

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

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

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Key information

Conditions

Depression Behavior Behavioral Symptoms Motor Activity

Age range

11 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Centre for Mental Health Research

Canberra, Australian Capital Territory, 0200, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Self-motivated physical activity

Behavioral

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

Behavioral

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

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

Primary outcomes

  1. 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

  2. Physical activity levels

    Time frame: Baseline, 8 weeks and 4 month post-intervention follow-up

Secondary outcomes

  1. Anxiety (RCMAS)

    Time frame: Baseline, 8 weeks, and 4 month post-intervention follow-up

Sponsors and collaborators

Lead sponsor

Australian National University

Other

Registry information

Official study 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.

Acronym: IN2SHAPE

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Aug 20, 2008
Registry last updated
Jul 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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