NCT01482975

Brief Summary

The overarching objective of this research is to prevent substance use in early adolescents through the use of innovative interactive interventions tailored to each individual's particular risk profile for using cigarettes and alcohol. The specific aims are: (1) To test the effectiveness of the computer-based profile-based tailored interventions to keep early adolescents smoke-free compared to a comparison group; (2) To test the effectiveness of the computer-based profile-based tailored interventions to keep early adolescents from using alcohol compared to a comparison group; and (3) To replicate findings that the tailored diet and physical activity interventions will be effective in reducing these two high risk behaviors as part of the comparison condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,158

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2007

Longer than P75 for not_applicable

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

September 1, 2007

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2011

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

3.8 years

First QC Date

November 29, 2011

Last Update Submit

May 10, 2016

Conditions

Keywords

tobaccoalcoholdietexercise

Outcome Measures

Primary Outcomes (4)

  • Smoking Prevention

    Percent reporting being smoke-free at 36 months

    36 months

  • Alcohol Use Prevention

    Percent reporting being alcohol-free at 36 months

    36 months

  • Exercise

    Percentage of baseline at-risk participants who reach the Regular Exercise criteria (60 minutes a day/five days per week).

    36 months

  • Diet

    Percentage of at-risk participants at baseline who reach Diet Criteria (five or more a day servings of fruits and vegetables).

    36 months

Study Arms (2)

Smoking and Alcohol Prevention

EXPERIMENTAL

TTM expert system

Other: Tailored computer based intervention

Diet and Exercise

ACTIVE COMPARATOR

TTM expert system

Other: Tailored computer intervention

Interventions

Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment.

Also known as: Tailored computer based interventions
Smoking and Alcohol Prevention

Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment

Diet and Exercise

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • th grade student in one of 20 participating Middle Schools in RI
  • English speaking
  • Student Assent

You may not qualify if:

  • Parent refusal for child to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rhode Island

Kingston, Rhode Island, 02881, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Wayne F Velicer, PhD

    Univeristy of Rhode Island

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 29, 2011

First Posted

December 1, 2011

Study Start

September 1, 2007

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 12, 2016

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share

Locations