NCT01033253

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
Last Updated

December 16, 2009

Status Verified

December 1, 2009

Enrollment Period

2.4 years

First QC Date

December 14, 2009

Last Update Submit

December 15, 2009

Conditions

Physical ActivityNutritionObesity Prevention

Outcome Measures

Primary Outcomes (3)

  • The number of days per week for which students got at least 60 minutes of physical activity

    2, 6, and 12 months

  • The number of servings of fruits and vegetables consumed each day

    2, 6, and 12 months

  • The number of hours of TV watch each day, including time spent watching TV, videotapes, and DVD's

    2, 6, and 12 months

Secondary Outcomes (3)

  • 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

  • Stage of change for readiness to eat at least five servings of fruits and vegetables each day.

    2, 6, and 12 months

  • Stage of change for readiness to watch two hours or less of TV each day.

    2, 6, and 12 months

Study Arms (2)

Computerized Tailored Intervention

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Health in MotionBEHAVIORAL

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 Tailored Intervention

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pro-Change Behavior Systems, Inc.

Kingston, Rhode Island, 02892, United States

Location

Related 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. doi: 10.1016/j.ypmed.2007.07.028. Epub 2007 Aug 1.

    PMID: 17714771BACKGROUND

  • 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.

    PMID: 17172199BACKGROUND

  • 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.

    PMID: 18605653BACKGROUND

MeSH Terms

Conditions

Motor Activity

Interventions

HealthMotion

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Population CharacteristicsPhysical Phenomena

Study Officials

  • Leanne Mauriello, Ph.D.

    Pro-Change Behavior Systems

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 14, 2009

First Posted

December 16, 2009

Study Start

July 1, 2005

Primary Completion

December 1, 2007

Study Completion

July 1, 2008

Last Updated

December 16, 2009

Record last verified: 2009-12

Locations

US(1)