Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-28 @ 1:52 AM
Study NCT ID:
NCT00738634
Status:
COMPLETED
Last Update Posted:
2012-07-20
First Post:
2008-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IN2SHAPE: A Study of Physical Activity and Depressive Symptoms in Adolescence
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009752', 'term': 'Nutritional Status'}], 'ancestors': [{'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-18', 'studyFirstSubmitDate': '2008-08-18', 'studyFirstSubmitQcDate': '2008-08-18', 'lastUpdatePostDateStruct': {'date': '2012-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression as measured by the Centre for Epidemiological Studies-Depression Scale (CES-D)', 'timeFrame': 'Baseline, 8 weeks and 4 month post-intervention follow-up'}, {'measure': 'Physical activity levels', 'timeFrame': 'Baseline, 8 weeks and 4 month post-intervention follow-up'}], 'secondaryOutcomes': [{'measure': 'Anxiety (RCMAS)', 'timeFrame': 'Baseline, 8 weeks, and 4 month post-intervention follow-up'}]}, 'conditionsModule': {'keywords': ['Depression', 'Motor Activity', 'Adolescent'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether physical activity prevents development of depressive symptoms in adolescents.', 'detailedDescription': '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.\n\nA further objective is to evaluate the feasibility of a novel self-motivated physical activity intervention, which has been designed for this project.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adolescents from Grades 7-10 (high school) and their parents/guardians.\n* Adolescents scoring in the middle range (14-30) on the Centre for Epidemiological Studies-Depression Scale (possible range 0-60).\n\nExclusion Criteria:\n\n* Adolescents currently engaging in 60+ minutes of physical activity per day.\n* Adolescents who have experienced psychosis, schizophrenia or bipolar disorder.\n* Adolescents who score \\>30 on the CES-D (indicator of severe depression).\n* Adolescents who have physical health problems or conditions which preclude them from participation in regular physical activity.\n* Lack of written consent from adolescent and/or parent guardian.'}, 'identificationModule': {'nctId': 'NCT00738634', 'acronym': 'IN2SHAPE', 'briefTitle': 'IN2SHAPE: A Study of Physical Activity and Depressive Symptoms in Adolescence', 'organization': {'class': 'OTHER', 'fullName': 'Australian National University'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '2008/008 HREC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Physical activity mediated', 'description': 'Self-motivated physical activity intervention\n\nMaterials mailed to participants', 'interventionNames': ['Behavioral: Self-motivated physical activity']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrition control', 'description': 'Nutrition attention-control arm.\n\nDelivered by researcher.', 'interventionNames': ['Behavioral: Nutrition']}, {'type': 'EXPERIMENTAL', 'label': 'Physical activity researcher contact', 'description': 'Self-motivated physical activity intervention\n\nDelivered by researcher.', 'interventionNames': ['Behavioral: Physical activity researcher contact']}], 'interventions': [{'name': 'Self-motivated physical activity', 'type': 'BEHAVIORAL', 'description': 'Components:\n\n1. Physical activity education in the form of a brief booklet (double sided A4 page).\n2. Physical activity motivation tips (one sided A4 page).\n3. Pedometer\n4. Monitoring chart\n5. Online presentation of common obstacles and ways to overcome these obstacles', 'armGroupLabels': ['Physical activity mediated']}, {'name': 'Nutrition', 'type': 'BEHAVIORAL', 'description': 'Components:\n\n1. Nutrition education booklet (Double-sided A4 page)\n2. Nutrition motivation tips (single-sided A4 page)\n3. Nutrition monitoring chart\n4. Online presentation of common obstacles and ways to overcome these obstacles', 'armGroupLabels': ['Nutrition control']}, {'name': 'Physical activity researcher contact', 'type': 'BEHAVIORAL', 'description': 'Behavioral: Self-motivated physical activity\n\nComponents:\n\n1. Physical activity education in the form of a brief booklet (double sided A4 page).\n2. Physical activity motivation tips (one sided A4 page).\n3. Pedometer\n4. Monitoring chart\n5. Online presentation of common obstacles and ways to overcome these obstacles', 'armGroupLabels': ['Physical activity researcher contact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0200', 'city': 'Canberra', 'state': 'Australian Capital Territory', 'country': 'Australia', 'facility': 'The Centre for Mental Health Research', 'geoPoint': {'lat': -35.28346, 'lon': 149.12807}}], 'overallOfficials': [{'name': 'Jacqueline L Brewer, BPsyc Hons', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Australian National University'}, {'name': 'Janine Walker, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Australian National University'}, {'name': 'Prof Helen Christensen, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The Australian National University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Australian National University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ms', 'investigatorFullName': 'Jacqui Brewer', 'investigatorAffiliation': 'Australian National University'}}}}