DepressionIN2SHAPENCT00738634
IN2SHAPE: A Study of Physical Activity and Depressive Symptoms in Adolescence
A study testing Self-motivated physical activity, Nutrition and Physical activity researcher contact in people with Depression, run by Australian National University at 1 site in Australia.
Trial summary
The purpose of this study is to determine whether physical activity prevents development of depressive symptoms in adolescents. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- Self-motivated physical activity, Nutrition and Physical activity researcher contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2008to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site
The Centre for Mental Health Research
Canberra, Australian Capital Territory, 0200
About this study
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.
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.
- Conditions
- Depression
- Being tested
- Self-motivated physical activity, Nutrition, Physical activity researcher contact
- Keywords
- Depression, Motor Activity, Adolescent
- Medical subject headings
- Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-motivated physical activityBehavioural
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
NutritionBehavioural
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 contactBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Physical activity mediated | Experimental | Self-motivated physical activity intervention
Materials mailed to participants Receives: Behavioral: Self-motivated physical activity |
| Nutrition control | Active comparator | Nutrition attention-control arm.
Delivered by researcher. Receives: Behavioral: Nutrition |
| Physical activity researcher contact | Experimental | Self-motivated physical activity intervention
Delivered by researcher. Receives: Behavioral: Physical activity researcher contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression as measured by the Centre for Epidemiological Studies-Depression Scale (CES-D)
Measured: Baseline, 8 weeks and 4 month post-intervention follow-up
Physical activity levels
Measured: Baseline, 8 weeks and 4 month post-intervention follow-up
Secondary outcomes (1)
Anxiety (RCMAS)
Measured: Baseline, 8 weeks, and 4 month post-intervention follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacqui Brewer, Australian National University
- Investigators
- Jacqueline L Brewer, BPsyc Hons, Principal investigator, The Australian National UniversityJanine Walker, PhD, Study chair, The Australian National UniversityProf Helen Christensen, PhD, Study director, The Australian National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00738634
- Sponsor's protocol ID
- 2008/008 HREC
- Acronym
- IN2SHAPE
- Status last verified
- Jul 2012
- First submitted
- 18 Aug 2008
- Last updated
- 20 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00738634
- Acronym / sponsor ID
- IN2SHAPE / 2008/008 HREC
- Conditions
- Depression
- Keywords
- Depression, Motor Activity, Adolescent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Australian National UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Physical activity mediated | Experimental | Behavioral: Self-motivated physical activitySelf-motivated physical activity intervention Materials mailed to participants |
| Nutrition control | Active comparator | Behavioral: NutritionNutrition attention-control arm. Delivered by researcher. |
| Physical activity researcher contact | Experimental | Behavioral: Physical activity researcher contactSelf-motivated physical activity intervention Delivered by researcher. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-motivated physical activityComponents: 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 | Behavioural | Physical activity mediated |
| NutritionComponents: 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 | Behavioural | Nutrition control |
| Physical activity researcher contactBehavioral: 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 | Behavioural | Physical activity researcher contact |
Primary outcome
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
Physical activity levels
Time frame: Baseline, 8 weeks and 4 month post-intervention follow-up
1 secondary outcome
Anxiety (RCMAS)
Time frame: Baseline, 8 weeks, and 4 month post-intervention follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-motivated physical activity, Nutrition and Physical activity researcher contact in people with Depression, run by Australian National University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2012.