Trial Outcomes & Findings for Hutchinson Smoking Prevention Project (NCT NCT00115869)

Results Overview

Response "1 to 3 cigarettes per day," "4 to 10 cigarettes per day," "11 to 20 cigarettes per day," or "More than 20 cigarettes per day" to the Item "How often do you currently smoke cigarettes?"

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

8388 participants

Primary outcome timeframe

12th grade

Results posted on

2012-11-29

Participant Flow

Study participants were recruited as 3rd graders in the consecutive years from 40 collaborating school districts in Washington State. The study participants were recruited in 3 waves: Wave I, 6 school districts (1984 and 1985); Wave II, 14 school districts (1985 and 1986); and Wave III, 20 school districts (1986 and 1987).

Forty-two (42) children were not eligible for the study because they were considered by their schools to be developmentally unable to learn.

Participant milestones

Participant milestones
Measure	No-intervention Control No-intervention control group	Grade 3-12 School-based Intervention Grade 3-12 school-influences school-based smoking prevention intervention
Overall Study STARTED	4211	4177
Overall Study Completed Data Collection at 12th Grade	3876	3847
Overall Study COMPLETED	3894	3881
Overall Study NOT COMPLETED	317	296

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Hutchinson Smoking Prevention Project

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	No-intervention Control n=4211 Participants No-intervention control group	Social Influences School-based Smoking Prevention Curriculum n=4177 Participants Social influences school-based smoking prevention curriculum group	Total n=8388 Participants Total of all reporting groups
Age, Categorical <=18 years	4211 Participants n=5 Participants	4177 Participants n=7 Participants	8388 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2058 Participants n=5 Participants	2073 Participants n=7 Participants	4131 Participants n=5 Participants
Sex: Female, Male Male	2153 Participants n=5 Participants	2104 Participants n=7 Participants	4257 Participants n=5 Participants
Region of Enrollment United States	4211 participants n=5 Participants	4177 participants n=7 Participants	8388 participants n=5 Participants

PRIMARY outcome

Timeframe: 12th grade

Response "1 to 3 cigarettes per day," "4 to 10 cigarettes per day," "11 to 20 cigarettes per day," or "More than 20 cigarettes per day" to the Item "How often do you currently smoke cigarettes?"

Outcome measures

Outcome measures
Measure	No-intervention Control n=3876 Participants No-intervention control condition	Social Influences School-based Smoking Prevention Curriculum n=3847 Participants School-based social-influences smoking prevention curriculum condition
Number of Participants Smoking Daily at 12th Grade	995 participants	976 participants

PRIMARY outcome

Timeframe: 2 years after high school

Response (from the 2-years-after-high school questionnaire) "Daily: 1 to 10 cigarettes a day," "Daily: 11 to 20 cigarettes a day," "Daily: more than a pack a day" to the Item "How often do you currently smoke cigarettes?"

Outcome measures

Outcome measures
Measure	No-intervention Control n=3894 Participants No-intervention control condition	Social Influences School-based Smoking Prevention Curriculum n=3881 Participants School-based social-influences smoking prevention curriculum condition
Whether or Not Smoking Daily at 2 Years After High School	1132 participants	1103 participants

Adverse Events

No-intervention Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

School-based Smoking Prevention Curriculum Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Arthur V. Peterson, Jr. PhD

Fred Hutchinson Cancer Research Center

Phone: 206-667-5131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place