- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01033253
Multi-media Obesity Prevention Program for Adolescents
December 15, 2009 updated by: Pro-Change Behavior Systems
The objective of this project was to evaluate a population-based, computerized tailored intervention that addresses recommended guidelines for three target behaviors related to obesity risk: physical activity (at least 60 minutes on at least 5 days per week), fruit and vegetable consumption (at least 5 servings of fruits and vegetables each day), and limited TV viewing (2 hours or less of TV each day).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1800
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Rhode Island
-
Kingston, Rhode Island, United States, 02892
- Pro-Change Behavior Systems, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
13 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- English speaking
- In the 9th, 10th, or 11th grade at baseline
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Computerized Tailored Intervention
Students interacted with the 30-minute program through a series of Transtheoretical Model (TTM) based assessments and tailored feedback messages.
A full TTM intervention was delivered for physical activity, in which each of the appropriate constructs of the TTM based on stage of change was addressed.
Optimally tailored interventions were delivered for fruit and vegetable consumption and limited TV viewing.
These interventions offered feedback on the most important TTM constructs based on stage of change for each behavior.
Multimedia components, including audio, video, and animations helped to capture students' interest.
|
Students interacted with the 30-minute program through a series of Transtheoretical Model (TTM) based assessments and tailored feedback messages.
A full TTM intervention was delivered for physical activity, in which each of the appropriate constructs of the TTM based on stage of change was addressed.
Optimally tailored interventions were delivered for fruit and vegetable consumption and limited TV viewing.
These interventions offered feedback on the most important TTM constructs based on stage of change for each behavior.
Multimedia components, including audio, video, and animations helped to capture students' interest.
|
|
No Intervention: Control
Computerized assessments of Transtheoretical Model constructs at 0, 2, 6, and 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The number of days per week for which students got at least 60 minutes of physical activity
Time Frame: 2, 6, and 12 months
|
2, 6, and 12 months
|
|
The number of servings of fruits and vegetables consumed each day
Time Frame: 2, 6, and 12 months
|
2, 6, and 12 months
|
|
The number of hours of TV watch each day, including time spent watching TV, videotapes, and DVD's
Time Frame: 2, 6, and 12 months
|
2, 6, and 12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Stage of change for readiness to do at least 60 minutes of physical activity on at least 5 days of the week
Time Frame: 2, 6, and 12 months
|
2, 6, and 12 months
|
|
Stage of change for readiness to eat at least five servings of fruits and vegetables each day.
Time Frame: 2, 6, and 12 months
|
2, 6, and 12 months
|
|
Stage of change for readiness to watch two hours or less of TV each day.
Time Frame: 2, 6, and 12 months
|
2, 6, and 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Leanne Mauriello, Ph.D., Pro-Change Behavior Systems
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Driskell MM, Dyment S, Mauriello L, Castle P, Sherman K. Relationships among multiple behaviors for childhood and adolescent obesity prevention. Prev Med. 2008 Mar;46(3):209-15. doi: 10.1016/j.ypmed.2007.07.028. Epub 2007 Aug 1.
- Mauriello LM, Driskell MM, Sherman KJ, Johnson SS, Prochaska JM, Prochaska JO. Acceptability of a school-based intervention for the prevention of adolescent obesity. J Sch Nurs. 2006 Oct;22(5):269-77. doi: 10.1177/10598405060220050501.
- Mauriello LM, Sherman KJ, Driskell MM, Prochaska JM. Using interactive behavior change technology to intervene on physical activity and nutrition with adolescents. Adolesc Med State Art Rev. 2007 Aug;18(2):383-99, xiii.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Primary Completion (Actual)
December 1, 2007
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
December 14, 2009
First Submitted That Met QC Criteria
December 15, 2009
First Posted (Estimate)
December 16, 2009
Study Record Updates
Last Update Posted (Estimate)
December 16, 2009
Last Update Submitted That Met QC Criteria
December 15, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R44HL074482-02 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Physical Activity
-
Muğla Sıtkı Koçman UniversityEge UniversityCompletedPhysical Activity | Physical Activity Behavior | Physical Activity LevelsTurkey
-
Istinye UniversityCompletedPhysical Activity | Youth | Physical Activity Barriers | Physical Activity FacilitatorsTurkey
-
Universidad Pedagogica Nacional, ColombiaEnrolling by invitationPhysical Activity | Running | Running Performance | Running Endurance | Physical Activity in Adults | Physical Activity IntensityColombia
-
University of ManitobaResearch ManitobaCompletedPhysical Activity | Physical Activity Self-Definition
-
Istanbul Kültür UniversityWithdrawnPhysical Activity Level | Physical Activity Awareness
-
Universidade do PortoActive, not recruitingPhysical Activity | Physical Fitness | Well BeingPortugal
-
Odense University HospitalUniversity of Southern DenmarkRecruitingQuality of Life | Physical Activity | Physical Disability | Physical Function | ParticipationDenmark
-
Firat UniversityNot yet recruitingUniversity Students | Physical Activity Level | Postural Awareness | Physical Activity AttitudeTurkey
-
Pham Ngoc Thach University of MedicineCompletedModerate Physical Activity (MPA) | Vigorous Physical Activity (VPA) | Moderate to Vigorous Physical Activity (MVPA) | Total of Sleep Time (TST)Vietnam
-
Georgetown UniversityUniversity of PennsylvaniaCompletedPhysical Activity | Motor ActivityUnited States
Clinical Trials on Health in Motion
-
Pro-Change Behavior SystemsCompletedViolence | Bullying
-
Cairo UniversityCompleted
-
National Institute on Aging (NIA)CompletedSedentary Lifestyle | InactivityUnited States
-
St. Olavs HospitalNorwegian University of Science and Technology; University of Illinois at Chicago and other collaboratorsCompletedCerebral PalsyNorway, Belgium, Denmark
-
National Institute on Aging (NIA)Completed
-
Northwell HealthRecruitingStroke | HemiparesisUnited States
-
Regina Elena Cancer InstituteUniversità degli studi di Roma Foro Italico; Azienda Policlinico Umberto IRecruitingMotion Analysis in Musculoskeletal OncologyItaly
-
Gallaudet UniversityNational Institute on Aging (NIA)Active, not recruitingFall | Old Age | Deaf | American Sign LanguageUnited States
-
University of ArizonaUniversity of North Texas Health Science CenterCompletedEffectiveness of BIM in Reducing Disordered Eating Among Student Athletes | Effectiveness of BIM in Reducing Body Image Concerns Among Student Athletes | Effectiveness of BIM Improving Psychological Well-Being Among Student AthletesUnited States