NCT02701530

Brief Summary

The aim of this trial is to develop a new tailored smoking cessation program for smokers with low education. Smokers are involved in design of the intervention. The effect of the intervention is then tested in a randomised controlled trial. Half of workplaces will be offered the intervention and the other half will be control group, not receiving any offer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,003

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 8, 2016

Completed
Last Updated

March 15, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

February 22, 2016

Last Update Submit

March 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Smoking rate in hospitals randomised to intervention or control group

    Self-reported point abstinence

    12 months

Secondary Outcomes (2)

  • Smoking cessation rate in persons participating in the group-based intervention

    6 months

  • Smoking cessation rate in persons participating in the intervention

    6 weeks after fixed quit date

Study Arms (2)

Targeted smoking cessation

EXPERIMENTAL

Smoking cessation program tailored in cooperation with the target group; smokers with low education. Peer-based anti-relapse strategy. Recruitment strategy: peer-driven, written invitations and posters.

Behavioral: Targeted smoking cessation

Control

NO INTERVENTION

No smoking cessation program.

Interventions

Smoking cessation program developed in cooperation with and aimed at smokers with low education.

Also known as: Smoking cessation - tailored to smokers with low education
Targeted smoking cessation

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • We selected following seven positions/occupations as proxy for low socioeconomic status: cleaner, porter, kitchen staff, social and health care assistant, service assistant, technical staff and medial secretary.

You may not qualify if:

  • does not speak Danish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center for Prevention and Health

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Charlotta Pisinger, MD PhD MPH

    Research Center for Prevention and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Senior researcher Ass Prof

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 8, 2016

Study Start

August 1, 2013

Primary Completion

August 1, 2015

Study Completion

February 1, 2016

Last Updated

March 15, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will share

Will be stored in safe database at Research Center for Prevention and Health

Locations