Managing cigarette cravings using the Physical over Smoking (PoS) App

ISRCTN	ISRCTN55259451
DOI	https://doi.org/10.1186/ISRCTN55259451
Protocol serial number	N/A
Sponsor	University of Jyvaskyla
Funder	National Institute for Health and Welfare (TERVEYDEN JA HYVINVOINNIN LAITOS)

Submission date: 17/02/2015
Registration date: 25/02/2015
Last edited: 30/05/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Mary Chasandra
Public

Faculty of Sport and Health Sciences
Department of Sport Sciences
PO Box 35
Jyvaskyla
40014
Finland

Study information

Primary study design	Interventional
Study design	Two-arm intervention single-center parallel superiority pragmatic randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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)
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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
Completion date	31/12/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	50
Key inclusion criteria	Adult smokers
Key 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
Date of first enrolment	01/12/2014
Date of final enrolment	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

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Mary Chasandra.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	26/05/2017		Yes	No
Protocol article	protocol	22/10/2015		Yes	No
Basic results		17/01/2017	27/01/2017	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN55259451_BasicResults_17Jan17.docx: Uploaded 27/01/2017

Editorial Notes

30/05/2017: Publication reference added.
27/01/2017: Results summary uploaded.
26/10/2015: Publication reference added.