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Multi-media Obesity Prevention Program for Adolescents

Primary Purpose

Physical Activity, Nutrition, Obesity Prevention

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Health in Motion
Sponsored by
Pro-Change Behavior Systems
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Physical Activity

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • English speaking
  • In the 9th, 10th, or 11th grade at baseline

Exclusion Criteria:

-

Sites / Locations

  • Pro-Change Behavior Systems, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Computerized Tailored Intervention

Control

Arm Description

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.

Computerized assessments of Transtheoretical Model constructs at 0, 2, 6, and 12 months

Outcomes

Primary Outcome Measures

The number of days per week for which students got at least 60 minutes of physical activity
The number of servings of fruits and vegetables consumed each day
The number of hours of TV watch each day, including time spent watching TV, videotapes, and DVD's

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
Stage of change for readiness to eat at least five servings of fruits and vegetables each day.
Stage of change for readiness to watch two hours or less of TV each day.

Full Information

First Posted
December 14, 2009
Last Updated
December 15, 2009
Sponsor
Pro-Change Behavior Systems
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1. Study Identification

Unique Protocol Identification Number
NCT01033253
Brief Title
Multi-media Obesity Prevention Program for Adolescents
Official Title
Multi-media Obesity Prevention Program for Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pro-Change Behavior Systems

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity, Nutrition, Obesity Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized Tailored Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Computerized assessments of Transtheoretical Model constructs at 0, 2, 6, and 12 months
Intervention Type
Behavioral
Intervention Name(s)
Health in Motion
Intervention Description
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.
Primary Outcome Measure Information:
Title
The number of days per week for which students got at least 60 minutes of physical activity
Time Frame
2, 6, and 12 months
Title
The number of servings of fruits and vegetables consumed each day
Time Frame
2, 6, and 12 months
Title
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
Secondary Outcome Measure Information:
Title
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
Title
Stage of change for readiness to eat at least five servings of fruits and vegetables each day.
Time Frame
2, 6, and 12 months
Title
Stage of change for readiness to watch two hours or less of TV each day.
Time Frame
2, 6, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: English speaking In the 9th, 10th, or 11th grade at baseline Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne Mauriello, Ph.D.
Organizational Affiliation
Pro-Change Behavior Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pro-Change Behavior Systems, Inc.
City
Kingston
State/Province
Rhode Island
ZIP/Postal Code
02892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17714771
Citation
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.
Results Reference
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PubMed Identifier
17172199
Citation
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.
Results Reference
background
PubMed Identifier
18605653
Citation
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.
Results Reference
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Multi-media Obesity Prevention Program for Adolescents

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