NCT00670514

Brief Summary

Aim: to assess relative effectiveness of a high and a low intensity intervention for smoking cessation support in a dental clinic setting. Method: 300 smokers were randomly assigned to support with either low (LTI) or high treatment intensity (HTI). Main outcome measures were self-reported point-prevalence and continuous abstinence (≥183 days).

Trial Health

80
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2008

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 1, 2008

Completed
Last Updated

May 1, 2008

Status Verified

April 1, 2008

First QC Date

April 16, 2008

Last Update Submit

April 30, 2008

Conditions

Keywords

RCTtobaccotreatment intensitydentistryfollow-upSmoking cessationCost effectiveness

Outcome Measures

Primary Outcomes (1)

  • Point prevalence abstinence

Secondary Outcomes (1)

  • Continuous abstinence

Study Arms (2)

1 Nix Individual

ACTIVE COMPARATOR

High Treatment Intensity

Behavioral: Nix Individual

2 Fimpa dig fri

PLACEBO COMPARATOR

Low Treatment Intensity

Behavioral: Fimpa dig fri

Interventions

Nix IndividualBEHAVIORAL

Eight 40-minutes sessions at the local dental clinic during 4 months. Written material and counseling by a dental hygienist with special training in smoking cessation, according to a fixed program. A traditional smoking cessation program with a mixture of behavior therapy, coaching and pharmacological advises. Two questionnaires.

1 Nix Individual
Fimpa dig friBEHAVIORAL

One 30-minute counseling session at the local dental clinic, focusing on explaining the content of a traditional self-help program ("Fimpa dig fri"). The leaflet contains an 8-week program with instructions and tasks to perform. Two questionnaires.

2 Fimpa dig fri

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult daily smokers in the county of Västmanland

You may not qualify if:

  • Reading difficulties
  • Not fluent in the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for clinical research, Central Hospital

Västerås, 721 89, Sweden

Location

Related Publications (3)

  • 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.

  • Nohlert E, Ohrvik J, Tegelberg A, Tillgren P, Helgason AR. Long-term follow-up of a high- and a low-intensity smoking cessation intervention in a dental setting--a randomized trial. BMC Public Health. 2013 Jun 19;13:592. doi: 10.1186/1471-2458-13-592.

  • Nohlert E, Tegelberg A, Tillgren P, Johansson P, Rosenblad A, Helgason AR. Comparison of a high and a low intensity smoking cessation intervention in a dentistry setting in Sweden: a randomized trial. BMC Public Health. 2009 Apr 30;9:121. doi: 10.1186/1471-2458-9-121.

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 16, 2008

First Posted

May 1, 2008

Study Start

April 1, 2003

Last Updated

May 1, 2008

Record last verified: 2008-04

Locations