Multi-media Obesity Prevention Program for Adolescents
This study has been completed.
Sponsor:
Pro-Change Behavior Systems
Information provided by:
Pro-Change Behavior Systems
ClinicalTrials.gov Identifier:
NCT01033253
First received: December 14, 2009
Last updated: December 15, 2009
Last verified: December 2009
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Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
Physical Activity Nutrition Obesity Prevention |
Behavioral: Health in Motion |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Multi-media Obesity Prevention Program for Adolescents |
Resource links provided by NLM:
Further study details as provided by Pro-Change Behavior Systems:
Primary Outcome Measures:
- The number of days per week for which students got at least 60 minutes of physical activity [ Time Frame: 2, 6, and 12 months ] [ Designated as safety issue: No ]
- The number of servings of fruits and vegetables consumed each day [ Time Frame: 2, 6, and 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Stage of change for readiness to eat at least five servings of fruits and vegetables each day. [ Time Frame: 2, 6, and 12 months ] [ Designated as safety issue: No ]
- Stage of change for readiness to watch two hours or less of TV each day. [ Time Frame: 2, 6, and 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 1800 |
| Study Start Date: | July 2005 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Behavioral: Health in Motion
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
|
Eligibility| Ages Eligible for Study: | 13 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- English speaking
- In the 9th, 10th, or 11th grade at baseline
Exclusion Criteria:
-
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01033253
Locations
| United States, Rhode Island | |
| Pro-Change Behavior Systems, Inc. | |
| Kingston, Rhode Island, United States, 02892 | |
Sponsors and Collaborators
Pro-Change Behavior Systems
Investigators
| Principal Investigator: | Leanne Mauriello, Ph.D. | Pro-Change Behavior Systems |
More Information
Publications:
| Responsible Party: | Leanne Mauriello, Pro-Change Behavior Systems, Inc |
| ClinicalTrials.gov Identifier: | NCT01033253 History of Changes |
| Other Study ID Numbers: | R44 HL074482-02 |
| Study First Received: | December 14, 2009 |
| Last Updated: | December 15, 2009 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013