Tobacco Use CessationNCT02469779
Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions
A study testing Surveys, ASPIRE Website and ASPIRE Text-Based Website in people with Tobacco Use Cessation and Tobacco Prevention, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation, Tobacco Prevention
- What is being tested?
- Surveys, ASPIRE Website and ASPIRE Text-Based Website
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
- 10 will be White/Caucasian participants, 5 will be African American participants, 10 will be Hispanic participants, and 5 will be Asian participants.
- English speaking
Who cannot join
- 1)None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mt. Calvary Baptist Church
Houston, Texas, 77008
Young Men's Christian Association (YMCA)
Houston, Texas, 77253
About this study
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.
Read the detailed description
Participants complete up to 2 separate parts.
Part 1:
For Part 1, participants complete a survey about their mental and physical health and their opinions concerning health information and the internet. The survey takes about 15-20 minutes to complete.
Part 2:
If the results of the survey show eligibility, participants complete Part 2 of the study. For Part 2 participants are randomly assigned (as in a roll of dice) to 1 of 2 study groups. Participants have a 1 in 3 chance of being assigned to receive standard care. Participants have a 2 in 3 chance of being assigned to use the ASPIRE website. This is done because no one knows if one study group is better, the same, or worse than the other group.
If participant assigned to receive standard care, he or she is shown a website that has the same information presented in ASPIRE, but in text form.
Participants in both groups sit in front of a computer and go onto a website. Both the ASPIRE website and the text-based website have been designed for middle and high school students. The ASPIRE website has videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. The text-based website only has health information facts about smoking, the benefits of meditation, and healthy living. Participants complete 3 to 4 sessions using either the ASPIRE website or the text-based website throughout their first semester. Each session lasts about 40 minutes.
The use of the websites will be videotaped.
Follow-Up Surveys:
Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they complete their last session on the website. The follow-up surveys take about 15 minutes to complete.
Length of Study:
Active participation on this study is over after participants complete the follow-up survey. If participant does not continue onto Part 2 of the study, their active participation is over after they complete Part 1 of the study.
Other Information:
Participants take part in this study at their school during their after school program.
During the use of the website, each study participant is individually videotaped and audio recorded. The videotapes and audio recordings are used to help the research staff analyze each participant's use of the websites. The video tapes and audio recordings are stored on a password-protected encrypted hard drive that is stored in a locked office at MD Anderson. Only the study researcher and authorized members of the research staff are allowed to use the videotapes and audio recordings (for research purposes).
- Conditions
- Tobacco Use Cessation, Tobacco Prevention
- Being tested
- Surveys, ASPIRE Website, ASPIRE Text-Based Website, Follow Up Survey
- Keywords
- Tobacco Prevention, ASPIRE Website, Surveys, Questionnaires, Focus Groups, Health Interactive Website
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveysBehavioural
Also called Questionnaires
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.
ASPIRE WebsiteBehavioural
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 Text-Based WebsiteBehavioural
Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living.
Follow Up SurveyBehavioural
Also called Questionnaire
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Surveys; Behavioral: ASPIRE Website; Behavioral: 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. Receives: Behavioral: Surveys; Behavioral: ASPIRE Text-Based Website; Behavioral: Follow Up Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (3)
Emotional Response
Outcome measured using validated Likert scales. In addition, facial expressions of happiness, sadness, disgust, fear, anger, and surprise are measured using a software program of emotion recognition for facial movement. The software captures the extent of expression of each of the emotions on a scale from 0 to 1.
Measured: 4 days
Participants' Reported Qualitatively Attributes in ASPIRE
Participants' reported qualitatively attributes (i.e. features) in ASPIRE that they recall to be emotionally involving. This report conducted using open-ended questions.
Measured: 1 day
Relationship Between Emotional Involvement During Use of ASPIRE Website and Change in Susceptibility to Smoking
Generation of emotional expression during use of ASPIRE is dependent on data for use of ASPIRE features, and data for emotional expression. Recorded videos of participant's online behavior analyzed via manual content analysis. Recorded videos of online behavior (i.e. mouse movement on the screen, clicking, dragging behaviors, and what the webpage presents) also analyzed using N-vivo.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2015 (estimated)
- Study startDec 2013
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alex Prokhorov, MD, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02469779
- Sponsor's protocol ID
- 2013-0296
- Status last verified
- Feb 2021
- First submitted
- 9 Jun 2015
- Last updated
- 8 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28209560
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Middle and High School Students' Reactions to a Health Interactive Website: ASPIRE Reactions
- ClinicalTrials.gov ID
- NCT02469779
- Acronym / sponsor ID
- 2013-0296
- Conditions
- Tobacco Use Cessation, Tobacco Prevention
- Keywords
- Tobacco Prevention, ASPIRE Website, Surveys, Questionnaires, Focus Groups, Health Interactive Website
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Dec 2013 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 11 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants complete up to 2 separate parts.
Part 1:
For Part 1, participants complete a survey about their mental and physical health and their opinions concerning health information and the internet. The survey takes about 15-20 minutes to complete.
Part 2:
If the results of the survey show eligibility, participants complete Part 2 of the study. For Part 2 participants are randomly assigned (as in a roll of dice) to 1 of 2 study groups. Participants have a 1 in 3 chance of being assigned to receive standard care. Participants have a 2 in 3 chance of being assigned to use the ASPIRE website. This is done because no one knows if one study group is better, the same, or worse than the other group.
If participant assigned to receive standard care, he or she is shown a website that has the same information presented in ASPIRE, but in text form.
Participants in both groups sit in front of a computer and go onto a website. Both the ASPIRE website and the text-based website have been designed for middle and high school students. The ASPIRE website has videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. The text-based website only has health information facts about smoking, the benefits of meditation, and healthy living. Participants complete 3 to 4 sessions using either the ASPIRE website or the text-based website throughout their first semester. Each session lasts about 40 minutes.
The use of the websites will be videotaped.
Follow-Up Surveys:
Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they complete their last session on the website. The follow-up surveys take about 15 minutes to complete.
Length of Study:
Active participation on this study is over after participants complete the follow-up survey. If participant does not continue onto Part 2 of the study, their active participation is over after they complete Part 1 of the study.
Other Information:
Participants take part in this study at their school during their after school program.
During the use of the website, each study participant is individually videotaped and audio recorded. The videotapes and audio recordings are used to help the research staff analyze each participant's use of the websites. The video tapes and audio recordings are stored on a password-protected encrypted hard drive that is stored in a locked office at MD Anderson. Only the study researcher and authorized members of the research staff are allowed to use the videotapes and audio recordings (for research purposes).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASPIRE Group | Experimental | Behavioral: Surveys, Behavioral: ASPIRE Website, Behavioral: Follow Up SurveyParticipants 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. |
| Control Group | Active comparator | Behavioral: Surveys, Behavioral: ASPIRE Text-Based Website, Behavioral: Follow Up SurveyParticipants 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. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
- 10 will be White/Caucasian participants, 5 will be African American participants, 10 will be Hispanic participants, and 5 will be Asian participants.
Key exclusion criteria (1 listed)
- 1)None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveysAlso: QuestionnairesAt 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. | Behavioural | ASPIRE Group, Control Group |
| ASPIRE WebsiteParticipants 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 | Behavioural | ASPIRE Group |
| ASPIRE Text-Based WebsiteParticipants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living. | Behavioural | Control Group |
| Follow Up SurveyAlso: QuestionnaireParticipants 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. | Behavioural | ASPIRE Group, Control Group |
Primary outcome
Intention to Smoke
Time frame: 1 day
This outcome is measured using the validated susceptibility to smoke scale in a Likert scale format and baseline and immediate follow up.
3 secondary outcomes
Emotional Response
Time frame: 4 days
Participants' Reported Qualitatively Attributes in ASPIRE
Time frame: 1 day
Relationship Between Emotional Involvement During Use of ASPIRE Website and Change in Susceptibility to Smoking
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2021.
- Derived from this study: PubMed 28209560Khalil 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.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Prokhorov, MD, PHD principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surveys, ASPIRE Website and ASPIRE Text-Based Website in people with Tobacco Use Cessation and Tobacco Prevention, run by M.D. Anderson Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to Smoke (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02469779, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2021.