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Providers for Smoking Prevention Programs

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005331
First received: May 25, 2000
Last updated: May 12, 2016
Last verified: July 2000
  Purpose
To conduct a randomized controlled smoking prevention trial to evaluate quality of implementation and effectiveness, as a function of provider type (school teacher vs. nurse) and training (mediated vs. interactive).

Condition
Cardiovascular Diseases
Coronary Heart Disease Risk Reduction
Heart Diseases
Lung Diseases

Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: September 1988
Study Completion Date: February 1995
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005331     History of Changes
Other Study ID Numbers: 4152  R01HL036171 
Study First Received: May 25, 2000
Last Updated: May 12, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Lung Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Respiratory Tract Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on December 09, 2016