NCT02469779

Brief Summary

The goal of this research study is to learn how middle and high school students react to an interactive website called ASPIRE ( A Smoking Prevention Interactive Experience) and health information online and what their preferences are when using ASPIRE. Researchers hope to use the results of this study to design more effective online health programs to provide middle and high school students with up-to-date information about tobacco use, meditation, and general health and well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

December 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

7.2 years

First QC Date

June 9, 2015

Last Update Submit

February 5, 2021

Conditions

Keywords

Tobacco PreventionASPIRE WebsiteSurveysQuestionnairesFocus GroupsHealth Interactive Website

Outcome Measures

Primary Outcomes (1)

  • Intention to Smoke

    This outcome is measured using the validated susceptibility to smoke scale in a Likert scale format and baseline and immediate follow up.

    1 day

Secondary Outcomes (3)

  • Emotional Response

    4 days

  • Participants' Reported Qualitatively Attributes in ASPIRE

    1 day

  • Relationship Between Emotional Involvement During Use of ASPIRE Website and Change in Susceptibility to Smoking

    1 day

Study Arms (2)

ASPIRE Group

EXPERIMENTAL

Participants complete baseline survey. Participants view the ASPIRE website containing videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. This viewing will be videotaped and audio recorded. 3 to 4 sessions will be completed. After each website session, survey will be completed.

Behavioral: SurveysBehavioral: ASPIRE WebsiteBehavioral: Follow Up Survey

Control Group

ACTIVE COMPARATOR

Participants complete baseline survey. Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living. This viewing will be videotaped and audio recorded. 3 to 4 sessions will be completed. After each website session, survey will be completed.

Behavioral: SurveysBehavioral: ASPIRE Text-Based WebsiteBehavioral: Follow Up Survey

Interventions

SurveysBEHAVIORAL

At baseline participants complete survey about their mental and physical health and their opinions concerning health information and the internet. The survey will take about 15-20 minutes to complete.

Also known as: Questionnaires
ASPIRE GroupControl Group
ASPIRE WebsiteBEHAVIORAL

Participants view the ASPIRE website containing videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. This viewing will be videotaped

ASPIRE Group

Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living.

Control Group

Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they have completed their last session on the website.

Also known as: Questionnaire
ASPIRE GroupControl Group

Eligibility Criteria

Age11 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Ages 11 through 18 (11 and 18 included)
  • High school and Middle School students are both eligible
  • All 150 are nonsmokers. Nonsmokers are defined as individuals who have not smoked, not even part of a cigarette in the past year.
  • All will score above the median on smoking susceptibility
  • will be White/Caucasian participants, 5 will be African American participants, 10 will be Hispanic participants, and 5 will be Asian participants.
  • English speaking

You may not qualify if:

  • )None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mt. Calvary Baptist Church

Houston, Texas, 77008, United States

Location

Young Men's Christian Association (YMCA)

Houston, Texas, 77253, United States

Location

Related Publications (1)

  • Khalil GE, Wang H, Calabro KS, Mitra N, Shegog R, Prokhorov AV. From the Experience of Interactivity and Entertainment to Lower Intention to Smoke: A Randomized Controlled Trial and Path Analysis of a Web-Based Smoking Prevention Program for Adolescents. J Med Internet Res. 2017 Feb 16;19(2):e44. doi: 10.2196/jmir.7174.

Related Links

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Alex Prokhorov, MD, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 11, 2015

Study Start

December 1, 2013

Primary Completion

February 1, 2021

Study Completion

February 1, 2021

Last Updated

February 8, 2021

Record last verified: 2021-02

Locations