Completed

Providers for Smoking Prevention Programs

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Who is being recruted

Respiratory Tract Diseases+1

+ Cardiovascular Diseases

+ Heart Diseases

Until 100 Years
See all eligibility criteria
How is the trial designed

Observational
Study Start: September 1988
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: May 13, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1988

Actual date on which the first participant was enrolled.

DESIGN NARRATIVE: The study compared smoking prevention in junior high schools and in high schools either receiving or not receiving a school-wide community intervention. The junior high school curriculum was delivered to all volunteers in grades 6, 7, and 8 in each intervention school. All participants were tested five times: midway through grade 6 before the intervention began, and at the end of grades 7,8,9, and 10. The primary endpoint was self-reported smoking status at the ends of grades 8 and 10. The validity of smoking reports was enhanced with collection of breath carbon monoxide samples for all subjects at all test points. The study was extended for an additional three years to add to the three year, junior high, design a two arm comparison between high schools either receiving or not receiving a school-wide, community, intervention. The new high school intervention responded to both recent evidence of long term decay in junior high program effectiveness, and a trend toward greater high school smoking onset most notably among females. Secondary objectives for this Demonstration and Education research included (a) a test of the hypothesis that higher levels of implementation were associated with better outcomes; (b) preparation for diffusion of a complete set of curriculum, provider training, program implementation, and evaluation methods and materials; and (c) study of the effects of school environment on program effectiveness. One hundred junior high schools were randomly selected and assigned, 20 per condition, and some 5,000 Grade 6 youth with approximately the same number of females and males, recruited to cohort which participated in intervention and evaluation through the end of Grade 10. The junior high curriculum was delivered to all volunteers in each intervention school in Grades 6, 7, and 8. All participants were tested five times: midway through Grade 6 before the intervention began, and at the end of Grades 7, 8, 9 and 10. The primary endpoint was self-reported smoking status at the ends of Grades 8 and 10, 2 1/2 and 4 1/2 years after the intervention began. The validity of smoking reports were enhanced with collection of breath carbon monoxide samples from all subjects at all test points. The new high school intervention integrated three approaches: attitude-behavior change strategies derived from social psychological research on dissonance, self-perception, values, social norms, and commitment; organizational/cultural change strategies using student- driven participatory planning and multilevel change methods; and mobilization strategies adapted from the National Cancer Institute-funded Community Intervention Trial for Smoking Cessation (COMMIT). A comprehensive implementation evaluation used direct observation, multiple sources of self-report, program records, and cost data to assess the relationships between implementation, outcome, and cost- effectiveness; to provide direct measures of training and mobilization effects; and to develop feasible implementation evaluation methodology for future diffusion studies. The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

NCT00005331
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: May 13, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Male

Biological sex of participants that are eligible to enroll.

Until 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Respiratory Tract DiseasesCardiovascular DiseasesHeart DiseasesLung Diseases

Criteria

No eligibility criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers