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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01033253
Other study ID # R44HL074482-02
Secondary ID
Status Completed
Phase Phase 2
First received December 14, 2009
Last updated December 15, 2009
Start date July 2005
Est. completion date July 2008

Study information

Verified date December 2009
Source Pro-Change Behavior Systems
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 1800
Est. completion date July 2008
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 13 Years to 19 Years
Eligibility Inclusion Criteria:

- English speaking

- In the 9th, 10th, or 11th grade at baseline

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Pro-Change Behavior Systems, Inc. Kingston Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
Pro-Change Behavior Systems

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Epub 2007 Aug 1. — View 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. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The number of days per week for which students got at least 60 minutes of physical activity 2, 6, and 12 months No
Primary The number of servings of fruits and vegetables consumed each day 2, 6, and 12 months No
Primary The number of hours of TV watch each day, including time spent watching TV, videotapes, and DVD's 2, 6, and 12 months No
Secondary Stage of change for readiness to do at least 60 minutes of physical activity on at least 5 days of the week 2, 6, and 12 months No
Secondary Stage of change for readiness to eat at least five servings of fruits and vegetables each day. 2, 6, and 12 months No
Secondary Stage of change for readiness to watch two hours or less of TV each day. 2, 6, and 12 months No
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