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 aim of this study is to test how well the PoS App works in a group of adult smokers who have recently quit smoking in comparison to a group of non users of the App.
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 receive a short quit smoking counselling program and then they are randomly allocated to one of two groups. One group uses the PoS App when experiencing cigarette cravings as an aid to overcome the urge. The other group do not receive any after quit support. Both groups are followed up for 6 months after quit day.
What are the possible benefits and risks of participating?
All participants 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 (Finland)
When is the study starting and how long is it expected to run for?
February 2014 to December 2015
Who is funding the study?
National Institute for Health and Welfare (Finland)
Who is the main contact?
Mary Chasandra
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Secondary identifying numbers
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 two-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(s)
Central Finland Health Care District's Ethics Committee (Keski-Suomen sairaanhoitopiirin eettinen toimikunta), 14/10/2014 (no ref number)
Study design
Two-arm intervention single-center parallel superiority pragmatic randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Community
Study 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
Primary outcome measure
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 measured 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 study start date
01/02/2014
Overall study end date
31/12/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult smokers
Participant type(s)
Patient
Age group
Adult
Sex
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
Study 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
ROR
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.
Added 16/01/2017: The publication of the results paper is in progress.
Intention to publish date
31/12/2017
Individual participant data (IPD) Intention to share
Yes
IPD sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Mary Chasandra.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 22/10/2015 | Yes | No | |
| Basic results | 17/01/2017 | 27/01/2017 | No | No | |
| Results article | results | 26/05/2017 | Yes | No |
Additional files
- ISRCTN55259451_BasicResults_17Jan17.docx Uploaded 27/01/2017