Condition category
Mental and Behavioural Disorders
Date applied
17/02/2015
Date assigned
25/02/2015
Last edited
26/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Research evidence on smokers show that even relatively small doses of exercise can help to manage cigarette cravings and withdrawal symptoms. A smartphone application named Physical over Smoking (PoS) has been developed to support quitters to manage cigarette cravings by counter-suggesting short exercises, tailored to participants' information (gender, age etc) and current status (place, mood and social environment).
The purpose of this study is to test the effectiveness of the PoS App in a group of adult smokers who have recently quit smoking in comparison to a control group of non users of the App on behavioral and psychological measures.

Who can participate?
Adults with no other addictions or mental and physical problems who are addicted to cigarettes and want to quit smoking.

What does the study involve?
All participants will receive a short quit smoking counselling program and then they will randomly be allocated to one of two groups. One group will use the PoS App when experiencing cigarette cravings as an aid to overcome the urge. The other group will not receive any after quit support. Both groups will be followed up for 6 months after quit day.

What are the possible benefits and risks of participating?
All participants will benefit from the free counselling quit smoking program. There are no risks or any kind of harm involved.

Where is the study run from?
University of Jyvaskyla, Department of Sport Sciences, Jyvaskyla, Finland.

When is study starting and how long is it expected to run for?
From February 2014 to December 2015. Participants will be recruited until 01/05/2015.

Who is funding the study?
National Institute for Health and Welfare (TERVEYDEN JA HYVINVOINNIN LAITOS), Finland.

Who is the main contact?
Mary Hassandra
maria.m.chasandra@jyu.fi

Trial website

Contact information

Type

Public

Primary contact

Dr Mary Hassandra

ORCID ID

Contact details

Faculty of Sport and Health Sciences
Department of Sport Sciences
P.O. Box 35
Jyvaskyla
40014
Finland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effectiveness of a smartphone application on long term abstinence, awareness, efficacy and power of control of cigarette cravings of adult smokers: a 2-arm superiority randomised controlled trial

Acronym

Study hypothesis

1. Users of the PoS App will have higher abstinence rates at follow up measures in comparison to the control group
2. Users of the PoS App will report higher efficacy on being aware of experiencing cravings compared to the control group
3. Users of the PoS App will report higher efficacy on managing cravings compared to the control group
4. Users of the PoS App will report higher power of control to manage cravings compared to the control group

Ethics approval

Central Finland Health Care District's Ethics Committee (Keski-Suomen sairaanhoitopiirin eettinen toimikunta), 14/10/2014 (no ref number).

Study design

2-arm intervention single center parallel superiority pragmatic randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Use contact information to ask for the Participant Information sheet (in Finnish or a translation in English)

Condition

Tobacco smoking

Intervention

Participants identified as eligible and agreed to participate will receive a quit smoking counselling program. The program will consist of 3 motivational interviewing 2 hours weekly sessions. After they set their quit smoking day they will be randomly assigned to the experimental group (after quit support by using the Physical over Smoking App for managing their cravings) or to the control group (no after quit support) and have a 4th meeting. All participants will be followed for 6 months after the 4th meeting.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

1. Self report of tobacco use at a. before quit day; b. 1 & 2 & 3 weeks after 4th meeting; c. 1 & 3 & 6 months after 4th meeting. Cotinine in saliva at 4th meeting.
2. Self report of efficacy on being aware of experience cravings at a. before quit day; b. 1 & 2 & 3 weeks after 4th meeting; c. 1 & 3 & 6 months after 4th meeting.
3. Self report of efficacy on managing cravings at a. before quit day; b. 1 & 2 & 3 weeks after quit; c. 1 & 3 & 6 months after quit.
4. Self report of power of control to manage cravings at a. before quit day; b. 3 days after, c. 1 & 3 & 6 months after quit.

Secondary outcome measures

1. Self-reported current physical activity behavior (IPAQ) a. before quit day; b. 3 & 6 months after 4th meeting. 3 days measurement of step counts (pedometer) at before quit day time point
2. Self-reported attitudes, intentions and perceived behavioural control of quit smoking at before quit day time point
3. Self-reported attitudes, intentions and perceived behavioural control of craving management at a. before quit day; b. 4th meeting
4. Self-reported attitudes, intentions and perceived behavioural control of increase physical activity behavior at a. before quit day; b. 4th meeting
5. Self reported Usability of the Physical over Smoking App from experimental group only at a. 1 week; b. 1 month, 3 months & 6 months after 4th meeting
6. Fidelity checks in both groups at a. 3 days after 4th meeting and b. 1 week; c. 1 month, 3 months & 6 months after 4th meeting

Overall trial start date

01/02/2014

Overall trial end date

31/12/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Adult smokers

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

50 participants in total (25 for experimental group and 25 for control group)

Participant exclusion criteria

1. Patients with additional addictions (alcohol, drugs, etc) according to NIDA screening tool
2. High scores of active psychological distress according to GHQ-12: if scores 20+ on a scale from 0 to 36.
3. Low scores on Tobacco dependence screener (TDS): less than 5 on a scale from 1 to 10
4. Low scores on Motivation to stop smoking scale: less than 3 on a scale from 1 to 7
5. Health risks by increasing physical activity according to the screening tool of PAR-Q

Recruitment start date

01/12/2014

Recruitment end date

01/05/2015

Locations

Countries of recruitment

Finland

Trial participating centre

JYTE; Jyvaskyla Community Primary Health Care Center: Palokan terveysasema
Ritopohjantie 26
Jyvaskyla, Palokka
40270
Finland

Sponsor information

Organisation

University of Jyvaskyla

Sponsor details

Department of Sport Sciences
PO box 35
Keskussairaalantie 4
Building L
Jyvaskyla
40014
Finland

Sponsor type

University/education

Website

https://www.jyu.fi/sport/en

Funders

Funder type

Government

Funder name

National Institute for Health and Welfare (TERVEYDEN JA HYVINVOINNIN LAITOS)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Protocol paper submitted for publication before the end of April 2015.
Main results of the intervention paper submitted for publication before February 2016.

Intention to publish date

30/06/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26494256

Publication citations

Additional files

Editorial Notes

26/10/2015: Publication reference added.