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

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

Detailed Description
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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.

Official Title
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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.

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Self-motivated physical activity
* Behavioral: Nutrition
* Behavioral: Physical activity researcher contact


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity mediated<br>Self-motivated physical activity intervention Materials mailed to participants | Behavioral: Self-motivated physical activity<br>* 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<br>|
| Active Comparator: Nutrition control<br>Nutrition attention-control arm. Delivered by researcher. | Behavioral: Nutrition<br>* 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<br>|
| Experimental: Physical activity researcher contact<br>Self-motivated physical activity intervention Delivered by researcher. | Behavioral: Physical activity researcher contact<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety (RCMAS) |  | Baseline, 8 weeks, and 4 month post-intervention follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Motor Activity, Adolescent