NCT01487642

Brief Summary

The primary objective of the study is to compare the efficacy of four different smoking cessation programmes, including a proactive telephone counseling intervention, a reactive telephone counseling a and an interactive web-based intervention and (as control) written self-help material.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
unknown

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, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 20, 2011

Status Verified

December 1, 2011

Enrollment Period

1.3 years

First QC Date

November 24, 2011

Last Update Submit

December 19, 2011

Conditions

Outcome Measures

Primary Outcomes (1)

  • Smoking cessation

    We measure the 30 days point prevalence abstinence rate. We measure whether participants have been totally smokefree for at least 30 days prior to the follow-up date.

    14 months post baseline

Secondary Outcomes (6)

  • Smoking cessation

    3 month post baseline

  • smoking cessation

    8 month post baseline

  • Change in self-efficacy

    At 3, 8 and 14 months

  • Motivational change

    At 3, 8 and 14 months

  • Stage of change

    At 3, 8 and 14 months

  • +1 more secondary outcomes

Study Arms (4)

Telephone counselling

EXPERIMENTAL
Device: Standard 15-minute telephone counsellingDevice: Proactive telephone counselling

Proactive telephone counselling

EXPERIMENTAL
Device: Proactive telephone counselling

web-based smoking cessation programme

EXPERIMENTAL
Device: Interactive web-based smoking cessation programme

Self-help material

ACTIVE COMPARATOR
Device: Self-help material

Interventions

Subjects in arm 1 will benefit from a standard 15-minute telephone counselling session with a professional adviser which resembles a normal call to the national Quit-line. The telephone counselling will be reactive, thus the smoker initiates the call to a designated number to receive advice and information based on the needs and wishes of this particular smoker. Participants can receive self-help materials and information on other smoking cessation services if they wish.

Also known as: Stoplinien.dk
Telephone counselling

subjects in arm 2 will benefit from of five 15-minute calls from a professional adviser. Similar to the standard reactive telephone counselling, the proactive counselling will be a personal discussion and advice based on the needs and wishes of the particular participant. Together, the participant and adviser will determine a cessation date and schedule one call 3-7 days before the cessation date, one call immediately after the cessation date and three additional calls on days 3, 10 and 24, respectively, post-cessation.

Also known as: Stoplinien.dk
Proactive telephone counsellingTelephone counselling

Subjects in arm 3 will benefit from a tailored and interactive web-based smoking cessation programme. Besides interactive and personalised information generated on the webpage, the participant will receive by e-mail and SMS tailored feedback messages based on the particular profile of the participant on particular dates as well as topics during the cessation period depending on how well the cessation is proceeding.

Also known as: ddsp.dk
web-based smoking cessation programme

Participants receives self-help materials and on request information on other smoking cessation services if they wish.

Also known as: stoplinien.dk
Self-help material

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 16 and older
  • Current smoker: Willing to quit smoking within the next 12 weeks
  • Having a regular access to Internet
  • Having a personal e-mail address
  • Having a personal mobile cell phone with a Danish number
  • Given informed consent
  • Can read and understand Danish

You may not qualify if:

  • Less than 16 years of age
  • No personal e-mail address
  • No personal mobile cell phone
  • Not able to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National institute of Public Health, University of Southern Denmark

Copenhagen, 1353, Denmark

Location

Related Publications (2)

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

  • Skov-Ettrup LS, Dalum P, Bech M, Tolstrup JS. The effectiveness of telephone counselling and internet- and text-message-based support for smoking cessation: results from a randomized controlled trial. Addiction. 2016 Jul;111(7):1257-66. doi: 10.1111/add.13302. Epub 2016 Apr 13.

MeSH Terms

Conditions

SmokingSmoking Cessation

Condition Hierarchy (Ancestors)

BehaviorHealth Behavior

Study Officials

  • Peter Dalum, Ph.d

    University of Southern Denmark

    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
Primary investigator

Study Record Dates

First Submitted

November 24, 2011

First Posted

December 7, 2011

Study Start

August 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 20, 2011

Record last verified: 2011-12

Locations