Trial Outcomes & Findings for Pittsburgh and Rural Area High School Tobacco Prevention (NCT NCT05081843)
NCT ID: NCT05081843
Last Updated: 2025-06-04
Results Overview
Parents will be asked to return an opt out form if they do not want their student to participate. Students will provide assent if they wish to participate. Recruitment will be determined by calculating the percentage of eligible 9th grade students not opted out by their parents that also provide assent.
COMPLETED
NA
318 participants
1 month
2025-06-04
Participant Flow
Participant milestones
| Measure |
Usual Health Education Curriculum
Students will receive the school's usual health education curriculum.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Usual Health Education Curriculum Plus Intervention
Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.
AD IT UP media literacy intervention: AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
160
|
|
Overall Study
COMPLETED
|
23
|
15
|
|
Overall Study
NOT COMPLETED
|
135
|
145
|
Reasons for withdrawal
| Measure |
Usual Health Education Curriculum
Students will receive the school's usual health education curriculum.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Usual Health Education Curriculum Plus Intervention
Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.
AD IT UP media literacy intervention: AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
135
|
145
|
Baseline Characteristics
In one of our two schools, the administration did not want us to ask any questions about sex or gender. Therefore, this data reflects only the school that allowed this item.
Baseline characteristics by cohort
| Measure |
Usual Health Education Curriculum
n=158 Participants
Students will receive the school's usual health education curriculum.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Usual Health Education Curriculum Plus Intervention
n=160 Participants
Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.
AD IT UP media literacy intervention: AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Total
n=318 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
158 Participants
n=158 Participants
|
160 Participants
n=160 Participants
|
318 Participants
n=318 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=158 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=318 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=158 Participants
|
0 Participants
n=160 Participants
|
0 Participants
n=318 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=26 Participants • In one of our two schools, the administration did not want us to ask any questions about sex or gender. Therefore, this data reflects only the school that allowed this item.
|
7 Participants
n=21 Participants • In one of our two schools, the administration did not want us to ask any questions about sex or gender. Therefore, this data reflects only the school that allowed this item.
|
20 Participants
n=47 Participants • In one of our two schools, the administration did not want us to ask any questions about sex or gender. Therefore, this data reflects only the school that allowed this item.
|
|
Sex: Female, Male
Male
|
13 Participants
n=26 Participants • In one of our two schools, the administration did not want us to ask any questions about sex or gender. Therefore, this data reflects only the school that allowed this item.
|
14 Participants
n=21 Participants • In one of our two schools, the administration did not want us to ask any questions about sex or gender. Therefore, this data reflects only the school that allowed this item.
|
27 Participants
n=47 Participants • In one of our two schools, the administration did not want us to ask any questions about sex or gender. Therefore, this data reflects only the school that allowed this item.
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
97 Participants
n=158 Participants
|
109 Participants
n=160 Participants
|
206 Participants
n=318 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
8 Participants
n=158 Participants
|
4 Participants
n=160 Participants
|
12 Participants
n=318 Participants
|
|
Race/Ethnicity, Customized
Asian, non-Hispanic
|
19 Participants
n=158 Participants
|
17 Participants
n=160 Participants
|
36 Participants
n=318 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
5 Participants
n=158 Participants
|
9 Participants
n=160 Participants
|
14 Participants
n=318 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native, non-Hispanic
|
6 Participants
n=158 Participants
|
3 Participants
n=160 Participants
|
9 Participants
n=318 Participants
|
|
Race/Ethnicity, Customized
Multiracial, non-Hispanic
|
4 Participants
n=158 Participants
|
3 Participants
n=160 Participants
|
7 Participants
n=318 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=158 Participants
|
1 Participants
n=160 Participants
|
2 Participants
n=318 Participants
|
|
Race/Ethnicity, Customized
Missing
|
18 Participants
n=158 Participants
|
14 Participants
n=160 Participants
|
32 Participants
n=318 Participants
|
|
Region of Enrollment
United States
|
158 participants
n=158 Participants
|
160 participants
n=160 Participants
|
318 participants
n=318 Participants
|
|
Susceptible to cigarette use
Susceptible
|
11 Participants
n=158 Participants
|
18 Participants
n=160 Participants
|
29 Participants
n=318 Participants
|
|
Susceptible to cigarette use
Not Susceptible
|
120 Participants
n=158 Participants
|
116 Participants
n=160 Participants
|
236 Participants
n=318 Participants
|
|
Susceptible to cigarette use
Missing
|
27 Participants
n=158 Participants
|
26 Participants
n=160 Participants
|
53 Participants
n=318 Participants
|
|
Susceptible to cigar smoking
Susceptible
|
8 Participants
n=158 Participants
|
16 Participants
n=160 Participants
|
24 Participants
n=318 Participants
|
|
Susceptible to cigar smoking
Not Susceptible
|
124 Participants
n=158 Participants
|
119 Participants
n=160 Participants
|
243 Participants
n=318 Participants
|
|
Susceptible to cigar smoking
Missing
|
26 Participants
n=158 Participants
|
25 Participants
n=160 Participants
|
51 Participants
n=318 Participants
|
|
Susceptible to e-cigarette use
Susceptible
|
15 Participants
n=158 Participants
|
29 Participants
n=160 Participants
|
44 Participants
n=318 Participants
|
|
Susceptible to e-cigarette use
Not Susceptible
|
115 Participants
n=158 Participants
|
105 Participants
n=160 Participants
|
220 Participants
n=318 Participants
|
|
Susceptible to e-cigarette use
Missing
|
28 Participants
n=158 Participants
|
26 Participants
n=160 Participants
|
54 Participants
n=318 Participants
|
|
Susceptible to hookah use
Susceptible
|
10 Participants
n=158 Participants
|
14 Participants
n=160 Participants
|
24 Participants
n=318 Participants
|
|
Susceptible to hookah use
Not Susceptible
|
121 Participants
n=158 Participants
|
120 Participants
n=160 Participants
|
241 Participants
n=318 Participants
|
|
Susceptible to hookah use
Missing
|
27 Participants
n=158 Participants
|
26 Participants
n=160 Participants
|
53 Participants
n=318 Participants
|
|
Attitudes toward tobacco products
|
3.24 units on a scale
STANDARD_DEVIATION 1.53 • n=158 Participants
|
3.32 units on a scale
STANDARD_DEVIATION 1.36 • n=160 Participants
|
3.29 units on a scale
STANDARD_DEVIATION 1.45 • n=318 Participants
|
|
Normative Beliefs
|
2.27 units on a scale
STANDARD_DEVIATION 1.63 • n=158 Participants
|
2.14 units on a scale
STANDARD_DEVIATION 1.26 • n=160 Participants
|
2.21 units on a scale
STANDARD_DEVIATION 1.46 • n=318 Participants
|
|
Tobacco media literacy
|
7.78 units on a scale
STANDARD_DEVIATION 1.69 • n=158 Participants
|
7.79 units on a scale
STANDARD_DEVIATION 1.74 • n=160 Participants
|
7.79 units on a scale
STANDARD_DEVIATION 1.71 • n=318 Participants
|
PRIMARY outcome
Timeframe: 1 monthPopulation: These numbers are the number of students that were present in the classroom on the day of the initial data collection, and thus eligible to participate.
Parents will be asked to return an opt out form if they do not want their student to participate. Students will provide assent if they wish to participate. Recruitment will be determined by calculating the percentage of eligible 9th grade students not opted out by their parents that also provide assent.
Outcome measures
| Measure |
Usual Health Education Curriculum
n=218 Participants
Students will receive the school's usual health education curriculum.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Usual Health Education Curriculum Plus Intervention
n=194 Participants
Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.
AD IT UP media literacy intervention: AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
|---|---|---|
|
Percentage of Eligible 9th Grade Students Recruited to Participate in the Study
|
158 Participants
|
160 Participants
|
PRIMARY outcome
Timeframe: 12 monthsRetention will be calculated as the percentage of 9th grade students who completed the baseline survey and also completed the 12 month follow-up survey.
Outcome measures
| Measure |
Usual Health Education Curriculum
n=158 Participants
Students will receive the school's usual health education curriculum.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Usual Health Education Curriculum Plus Intervention
n=160 Participants
Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.
AD IT UP media literacy intervention: AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
|---|---|---|
|
Percentage of Participants Retained Through the Final Data Collection
|
23 Participants
|
15 Participants
|
PRIMARY outcome
Timeframe: post-test immediately following completion of the interventionPopulation: This data is from the intervention students who completed the post-test only.
Acceptability of the intervention will be assessed with closed-ended and open-ended items on the post-test survey immediately following completion of the intervention. Students will be asked on a 5-point Likert scale with responses ranging from Strongly Agree to Strongly Disagree (with a neutral middle) their agreement about the following: "I enjoyed AD IT UP," "I understood AD IT UP," "AD IT UP was easy to use," "I tried my hardest when I was doing AD IT UP," "I think AD IT UP would be helpful to other kids my age," "I would recommend AD IT UP to a friend," and "I agree with AD IT UP's message." An answer of "Strongly Agree" or "Agree" on these items indicates high and moderate acceptability, respectively. Each of these items will be assessed individually, not as an overall scale. Open-ended items will ask: what the student would change about AD IT UP, what the student liked about AD IT UP, what made AD IT UP fun, and what made AD IT UP not fun.
Outcome measures
| Measure |
Usual Health Education Curriculum
n=111 Participants
Students will receive the school's usual health education curriculum.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Usual Health Education Curriculum Plus Intervention
Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.
AD IT UP media literacy intervention: AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
|---|---|---|
|
Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program
Agreed with "I understood AD IT UP"
|
81 Participants
|
—
|
|
Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program
Agreed with "AD IT UP was easy to use"
|
62 Participants
|
—
|
|
Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program
Agreed with "I tried my hardest when using AD IT UP"
|
66 Participants
|
—
|
|
Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program
Agreed with "UP would be helpful to other kids my age"
|
64 Participants
|
—
|
|
Percentage of Participants Indicating Moderate to High Acceptability of the AD IT UP Program
Agreed with "I agree with AD IT UP's message"
|
82 Participants
|
—
|
SECONDARY outcome
Timeframe: baseline vs. 12 month follow-upPopulation: NOTE: The original analysis was to be conducted for change between baseline and 12-month follow-up. Due to loss to follow-up over the 12-month tme period, the results presented here are for the immediate post-test, for which there was less loss to follow-up.
Items used in this analysis: If one of your best friends offered you a \[NTP\], would you smoke/use it? This item was repeated for cigarettes, hookah, e-cigarettes, and cigars/cigarillos. This item included the a 4-item response scale ranging from Definitely No to Definitely Yes for each of the 4 NTPs. Susceptibility was considered any response except "Definitely No" and totaled for a possible range of 0 to 4. Answering anything other than "Definitely No" on any item is considered susceptible to using tobacco products. These were totaled for a possible range of 0 to 4, with higher scores representing greater susceptibility.
Outcome measures
| Measure |
Usual Health Education Curriculum
n=70 Participants
Students will receive the school's usual health education curriculum.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Usual Health Education Curriculum Plus Intervention
n=93 Participants
Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.
AD IT UP media literacy intervention: AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
|---|---|---|
|
Changes in Intention to Use Tobacco Products
|
0.386 units on a scale
Standard Deviation 0.997
|
0.419 units on a scale
Standard Deviation 1.116
|
SECONDARY outcome
Timeframe: baseline vs. 12 month follow-upPopulation: NOTE: The original analysis was to be conducted for change between baseline and 12- month follow-up. Due to loss to follow-up over the 12 month time period, the results presented here are for the immediate post-test, for which there was less loss to follow-up.
Items to measure attitudes toward tobacco products will be included in all 4 surveys. These items include the following with a 10-item response scale ranging from Strongly Disagree to Strongly Agree. E-cigarettes are not as bad for your health as other products. Using tobacco products at parties is fun. (added: Using e-cigarettes at parties is fun) Tobacco products help you deal with problems or stress. Smoking helps people stay thin. People who use e-cigarettes are more fun to be around than people who don't use e-cigarettes. If someone starts using tobacco products every day, it is very hard for them to stop (reverse coded). Smoking makes a person look more attractive. It would be very easy for me to get e-cigarettes if I wanted them. Change in attitudes will be determined by the average increase or decrease in agreement with these items. These items will be assessed individually and as an overall scale (range 0-90, with higher scores indicating a worse outcome).
Outcome measures
| Measure |
Usual Health Education Curriculum
n=73 Participants
Students will receive the school's usual health education curriculum.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Usual Health Education Curriculum Plus Intervention
n=98 Participants
Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.
AD IT UP media literacy intervention: AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
|---|---|---|
|
Changes in Attitudes Toward Tobacco Products
|
3.09 units on a scale
Standard Deviation 1.98
|
2.91 units on a scale
Standard Deviation 1.25
|
SECONDARY outcome
Timeframe: baseline vs. 12 month follow-upPopulation: NOTE: The original analysis was to be conducted for change between baseline and 12-month follow-up. Due to loss to follow-up over the 12 month time period, the results presented here are for the immediate post-test, for which there was less loss to sollow-up.
Items to measure normative beliefs about tobacco products will be included in all 4 surveys. These items ask participants their rate how acceptable the following statements are among their friends using a 10-item response scale ranging from Very Acceptable to Very Unacceptable: It is OK for people your age to smoke cigarettes. It is OK for people your age to use e-cigarettes. It is OK for people your age to use hookahs. It is OK for people your age to smoke cigars or cigarillos. A wealthy person is more likely to use tobacco products than a poor person. A successful person is more likely to use tobacco products than an unsuccessful person. Changes in normative beliefs will be determined by the average increase or decrease in perceived acceptability of these statements. These items will be assessed individually, as well as an overall scale (range 0-60 with higher scores indicating a worse outcome).
Outcome measures
| Measure |
Usual Health Education Curriculum
n=73 Participants
Students will receive the school's usual health education curriculum.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Usual Health Education Curriculum Plus Intervention
n=94 Participants
Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.
AD IT UP media literacy intervention: AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
|---|---|---|
|
Changes in Normative Beliefs About Tobacco Products
|
2.43 units on a scale
Standard Deviation 2.07
|
2.25 units on a scale
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: baseline vs. 12 month follow-upPopulation: NOTE: The original analysis was to be conducted for change between baseline and 12-month followup. Due to loss to follow-up over the 12 month time period, the results presented here are for the immediate post-test, for which there was less loss to follow-up.
Items to measure tobacco-related media literacy will be adapted from the Smoking Media Literacy Scale and included in all 4 surveys. The response scale for these 8 items is a 10-item scale from "Strongly Disagree" to "Strongly Agree." Changes in media literacy will be determined by the average increase or decrease in agreement with these items. These items will be assessed individually, as well as an overall scale (range 0-80, with higher scores indicating a worse outcome).
Outcome measures
| Measure |
Usual Health Education Curriculum
n=74 Participants
Students will receive the school's usual health education curriculum.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
Usual Health Education Curriculum Plus Intervention
n=100 Participants
Students will receive the school's usual health education curriculum. Students will also receive the intervention. Delivery of the intervention (i.e., timing, frequency) will be determined by discussing the results of the Aim 1 focus groups with teachers and administrators.
AD IT UP media literacy intervention: AD IT UP was originally developed in 2006 as a classroom-based cigarette prevention program focused on traditional media influences, and was converted to a web-based program in 2011. In 2019, the AD IT UP program was updated substantially to include other forms of tobacco, such as e-cigarettes, and other forms of media, such as social media.
Usual health education curriculum: The schools' regular health education curriculum includes classroom lectures, hands on activities and group work.
|
|---|---|---|
|
Change in Tobacco-related Media Literacy
|
7.98 units on a scale
Standard Deviation 1.68
|
8.89 units on a scale
Standard Deviation 1.79
|
Adverse Events
Usual Health Education Curriculum
Usual Health Education Curriculum Plus Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jaime Sidani
University of Pittsburgh School of Public Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place