NCT03579355

Brief Summary

This study evaluated a school-based tobacco program, "Dentists Fighting Nicotine Dependence (DFND)", to prevent the initiation of tobacco use among middle school students in Saudi Arabia using a social competences/social influence approaches.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
634

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2012

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2014

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

June 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 6, 2018

Completed
Last Updated

July 6, 2018

Status Verified

June 1, 2018

Enrollment Period

2 months

First QC Date

June 5, 2018

Last Update Submit

June 25, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline prevalence of tobacco use at one week and at 2 years [Questionnaire]

    Questionnaire administered one week and 2 years post-intervention: current use of tobacco

    One week and Two years after the completion of the intervention

Secondary Outcomes (3)

  • Change from baseline knowledge about tobacco at one week and at 2 years [Questionnaire]

    One week and two years after the completion of the intervention

  • Change from baseline in perceived behavioral control at one week and at 2 years [Questionnaire]

    One week and two years after the completion of the intervention

  • Change from baseline in attitude towards not using tobacco at one week and at two years[Questionnaire]

    One week and two years after the completion of the intervention

Study Arms (2)

DFND Program

EXPERIMENTAL

"Dentist Fighting Nicotine Dependence, (DFND)" intervention program consisted primarily of a 10-session curriculum, each session lasting about an hour. The curriculum was comprehensive and incorporated information about tobacco and its adverse health effects, social influences, and social competence skills. DFND was administered over 5 weeks, at a rate of 2 sessions per week. Each session lasts an hour. Fourteen classrooms in four schools represented the experimental arm and received DFND.

Behavioral: DFND Program

Informational Booklet

NO INTERVENTION

Fourteen classrooms in four schools represented the No Intervention arm (control). They received only an informational booklet about tobacco adverse health effects.

Interventions

DFND ProgramBEHAVIORAL

The DFND program consisted primarily of a 10-session curriculum, each session lasting about an hour. The curriculum was comprehensive and incorporated information about tobacco and its adverse health effects, social influences, and social competence skills.

DFND Program

Eligibility Criteria

Age12 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Students in 7th grade
  • Gave verbal assent

You may not qualify if:

  • no assent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Dania E Alagili, DrPH

    King Abdulaziz University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A quasi-experimental, controlled trial design was utilized to evaluate the effectiveness of a school-based tobacco program, "Dentists Fighting Nicotine Dependence (DFND)", to prevent the initiation of tobacco use among middle school students (grades 7-9) in Jeddah, Saudi Arabia. Eight middle schools were selected from the regional education registry; four allocated to treatment arm (n=379) and four to control arm (n=255). The treatment arm received the new tobacco prevention program (DFND) whereas the control arm received only the regular tobacco prevention program administered by the Department of Education. DFND was delivered by trained health educators over 5 weeks, two sessions per week.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 5, 2018

First Posted

July 6, 2018

Study Start

February 10, 2012

Primary Completion

March 30, 2012

Study Completion

April 15, 2014

Last Updated

July 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

There is no plan for sharing IPD with other researchers.