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CompletedNCT00738634IN2SHAPEUpdated Jul 20, 2012

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

An interventional study of Self-motivated physical activity and Nutrition in Depression, sponsored by Australian National University. Completed at 1 site in Australia. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2012-07-20.

Sponsored by Australian National University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
11 Years to 17 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Depression

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Keywords

  • Depression
  • Motor Activity
  • Adolescent
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 26 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Australian National University is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Physical activity mediated

    Self-motivated physical activity intervention Materials mailed to participants

    Behavioral: Self-motivated physical activity

  • Active comparator
    Nutrition control

    Nutrition attention-control arm. Delivered by researcher.

    Behavioral: Nutrition

  • Experimental
    Physical activity researcher contact

    Self-motivated physical activity intervention Delivered by researcher.

    Behavioral: Physical activity researcher contact

Interventions

  • BehavioralSelf-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

  • BehavioralNutrition

    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

  • BehavioralPhysical 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

06

What researchers measure

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

07

Study locations

1 site
  • The Centre for Mental Health Research
    Canberra, Australian Capital Territory 0200, Australia
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00738634
Lead sponsor
Australian National University
Responsible party
Jacqui Brewer (Ms, Australian National University) — Principal investigator
First posted
Aug 20, 2008
Start date
Jul 2008
Primary completion
Apr 2010
Completion
Apr 2010
Last update
Jul 20, 2012

Study contacts

Jacqueline L Brewer, BPsyc Hons
principal investigator · The Australian National University
Janine Walker, PhD
study chair · The Australian National University
Prof Helen Christensen, PhD
study director · The Australian National University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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