Viewing Study NCT00115869



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Study NCT ID: NCT00115869
Status: COMPLETED
Last Update Posted: 2012-11-29
First Post: 2005-06-26

Brief Title: Hutchinson Smoking Prevention Project
Sponsor: Fred Hutchinson Cancer Center
Organization: Fred Hutchinson Cancer Center

Study Overview

Official Title: Hutchinson Smoking Prevention Project
Status: COMPLETED
Status Verified Date: 2012-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: HSPP
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 US annually killing more than 400000 Americans Without reversal of adolescent smoking trends five million of todays 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 N8388 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 4675 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 CDCs best practices guidelines The interventions 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 topicsactivities that are interesting engaging and developmentally-appropriate for students

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
R01CA038269 NIH None httpsreporternihgovquickSearchR01CA038269