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Hutchinson Smoking Prevention Project (HSPP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00115869
Recruitment Status : Completed
First Posted : June 27, 2005
Results First Posted : November 29, 2012
Last Update Posted : November 29, 2012
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE June 26, 2005
First Posted Date  ICMJE June 27, 2005
Results First Submitted Date  ICMJE April 30, 2012
Results First Posted Date  ICMJE November 29, 2012
Last Update Posted Date November 29, 2012
Study Start Date  ICMJE September 1984
Actual Primary Completion Date August 1999   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
  • Number of Participants Smoking Daily at 12th Grade [ Time Frame: 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?"
  • Whether or Not Smoking Daily at 2 Years After High School [ Time Frame: 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?"
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2005)
  • Daily smoking at 12th grade
  • Daily smoking at 2 years after high school
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2005)
  • Binary measures of current smoking frequency
  • Ordinal measure of current smoking frequency
  • Ordinal measure of participant's smoking acquisition stage
  • Binary measure of cumulative lifetime smoking
  • Number of cigarettes smoked per day, among daily smokers
  • Grades in school when monthly, weekly, and daily smoking were first reported
  • Smokeless tobacco use
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Hutchinson Smoking Prevention Project
Official Title  ICMJE Hutchinson Smoking Prevention Project
Brief Summary The Hutchinson Smoking Prevention Project is a 16-year, group-randomized trial to determine the extent to which a school-based (grades 3-10), theory-based, social-influences tobacco use prevention intervention can deter youth tobacco use throughout and beyond high school.
Detailed Description

Cigarette smoking remains the number one cause of preventable premature death in the U.S., annually killing more than 400,000 Americans. Without reversal of adolescent smoking trends, five million of today's youth will die prematurely of smoking-related illnesses. The 16-year Hutchinson Smoking Prevention Project (HSPP) was conducted in 1984-1999 to (1) address challenges of trial design and execution in school-based smoking prevention by developing the most rigorous school-based randomized trial possible, and (2) use the trial to answer the scientific questions, "To what extent can a theory-based, social-influences smoking prevention intervention spanning elementary, middle and high school grades reduce smoking among youth at 12th grade and two years post-high-school?"

The HSPP trial used a group-randomized, matched pair design with the school district as the experimental unit. Of 40 participating school districts, 20 were randomly assigned to the experimental (intervention) condition and 20 were assigned to the control (no HSPP intervention) condition. No restrictions were placed on the health promotion or tobacco use prevention activities of the control districts, thus enabling schools to continue whatever health curricula were normally offered. Main endpoints were daily smoking at 12th grade and 2 years after high school (Plus-2). Study participants (N=8,388) were two consecutive third grade enrollments in each of the 40 school districts. All third graders were followed to endpoint, including those who dropped out of school or otherwise left their school districts. The study achieved a 94% follow-up rate at the Plus-2 endpoint.

The HSPP intervention was a teacher-led, grades 3-10 tobacco use prevention curriculum plus unit-specific teacher training. There were 65 classroom lessons in the HSPP curriculum: 9 lessons in each of grades 3-5, 10 lessons in each of grades 6-7, 8 lessons in grade 8, and 5 lessons in each of grades 9-10, for a total number of 46.75 hours of classroom instruction time in grades 3-10. The HSPP uses an enhanced social influences approach that includes the 15 NCI-endorsed "essential elements" for school-based tobacco prevention and meets the CDC's "best practices" guidelines. The intervention's behavioral components featured skills for identifying and resisting social influences to smoke, correcting erroneous normative perceptions regarding smoking, promoting tobacco-free norms, and building self-efficacy for tobacco-free lifestyle choices. The intervention was developed to be practical for the school setting, emphasizing ease of use by teachers, good fit into school routines and with schools' existing educational objectives, and incorporation of topics/activities that are interesting, engaging and developmentally-appropriate for students.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Smoking Among Youth
Intervention  ICMJE Behavioral: Social-influences
grades 3-10, school-based social influences tobacco use prevention curriculum
Study Arms  ICMJE
  • No Intervention: No-intervention control
  • Experimental: Social influences school-based smoking prevention curriculum
    Intervention: Behavioral: Social-influences
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 26, 2005)
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 1999
Actual Primary Completion Date August 1999   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • All students enrolled in third grade in one of two consecutive classes of third graders in an HSPP participating Washington school district (1984-85; 1985-86; 1986-87).

Exclusion Criteria:

  • Enrolled but classified by participating school district as developmentally unable to learn.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 9 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00115869
Other Study ID Numbers  ICMJE FHCRC IRB #324
R01CA038269 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Arthur V. Peterson, Jr., PhD, Fred Hutchinson Cancer Research Center
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Arthur V. Peterson, Jr., PhD Fred Hutchinson Cancer Research Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP