NCT00738634

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

July 20, 2012

Status Verified

July 1, 2012

Enrollment Period

1.8 years

First QC Date

August 18, 2008

Last Update Submit

July 18, 2012

Conditions

Keywords

DepressionMotor ActivityAdolescent

Outcome Measures

Primary Outcomes (2)

  • Depression as measured by the Centre for Epidemiological Studies-Depression Scale (CES-D)

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

  • Physical activity levels

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

Secondary Outcomes (1)

  • Anxiety (RCMAS)

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

Study Arms (3)

Physical activity mediated

EXPERIMENTAL

Self-motivated physical activity intervention Materials mailed to participants

Behavioral: Self-motivated physical activity

Nutrition control

ACTIVE COMPARATOR

Nutrition attention-control arm. Delivered by researcher.

Behavioral: Nutrition

Physical activity researcher contact

EXPERIMENTAL

Self-motivated physical activity intervention Delivered by researcher.

Behavioral: Physical activity researcher contact

Interventions

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

Physical activity mediated
NutritionBEHAVIORAL

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

Nutrition control

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

Physical activity researcher contact

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Centre for Mental Health Research

Canberra, Australian Capital Territory, 0200, Australia

Location

MeSH Terms

Conditions

DepressionMotor Activity

Interventions

Nutritional Status

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Nutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation Characteristics

Study Officials

  • Jacqueline L Brewer, BPsyc Hons

    The Australian National University

    PRINCIPAL INVESTIGATOR
  • Janine Walker, PhD

    The Australian National University

    STUDY CHAIR
  • Prof Helen Christensen, PhD

    The Australian National University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ms

Study Record Dates

First Submitted

August 18, 2008

First Posted

August 20, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

July 20, 2012

Record last verified: 2012-07

Locations