Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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3 July 2017 |
Main ID: |
ISRCTN55259451 |
Date of registration:
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25/02/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Managing cigarette cravings using the Physical over Smoking (PoS) App
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Scientific title:
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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 |
Date of first enrolment:
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01/12/2014 |
Target sample size:
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50 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN55259451 |
Study type:
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Interventional |
Study design:
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Two-arm intervention single-center parallel superiority pragmatic randomized controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Finland
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Mary
Chasandra |
Address:
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Faculty of Sport and Health Sciences
Department of Sport Sciences
PO Box 35
40014
Jyvaskyla
Finland |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Adult smokers
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Tobacco smoking Mental and Behavioural Disorders Smoking addiction
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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National Institute for Health and Welfare (TERVEYDEN JA HYVINVOINNIN LAITOS)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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