Tobacco Smoking BehaviorOCASTNCT01921439
OCAST Cessation Study
A study testing Personalized Feedback in people with Tobacco Smoking Behavior and Cigarette Smoking Behavior, run by University of Oklahoma at 1 site in United States.
Trial summary
The long-term goal is to improve the quality of life of children and their parents who smoke tobacco by facilitating parental smoking cessation in a way that is easy to administer yet effective. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking Behavior, Cigarette Smoking Behavior, Second Hand Tobacco Smoke
- What is being tested?
- Personalized Feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent or primary caregiver of a child patient at the OU Children's Physicians General Pediatrics clinics
- Current cigarette user
- Able to read study forms and verbally communicate with the study staff in English
Who cannot join
- Nonsmokers
- Unable to read or speak English well enough to complete the survey and study tasks
Trial locations and contacts
1 site in 1 country.
United States1 site
Oklahoma Tobacco Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Matching Brief Smoking Interventions to Stage of Change
The long-term goal is to improve the quality of life of children and their parents who smoke tobacco by facilitating parental smoking cessation in a way that is easy to administer yet effective. We aim to accomplish this goal by administering an interactive computer-based program that will facilitate motivation and readiness to engage in smoking cessation by providing personalized feedback about the financial and health effects of the parent's smoking. We will compare the changes in motivation and readiness to quit smoking after the parent has taken the computer-based program and compare them to the changes in motivation and readiness to quit in parents who receive only information about the Oklahoma Tobacco Helpline. We will also measure salivary cotinine levels in both parents and children, to objectively measure changes in smoking habits and secondhand smoke exposure. Our hypothesis is that our computer-based program will cause a greater increase in motivation and confidence to quit smoking in the group that receives the customized feedback than the group that receives only information about the Tobacco Helpline. We also predict that both parent and child cotinine levels will show a greater decrease in the group randomized to receive personalized feedback.
- Conditions
- Tobacco Smoking Behavior, Cigarette Smoking Behavior, Second Hand Tobacco Smoke, Tobacco Use Cessation
- Being tested
- Personalized Feedback
- Keywords
- smoking, quit smoking, smoking cessation, smoking study, secondhand smoke, smokers
- Medical subject headings
- Smoking, Cigarette Smoking, Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized FeedbackBehavioural
Personalized feedback reflecting the participant's current level of nicotine addiction, money spent on cigarettes, time spent smoking, and health effects of smoking.
| Study group | Role | What they receive |
|---|---|---|
| Feedback | Active comparator | Participants in this group will receive individualized feedback based on their stage of change. Feedback will include health effects of smoking, money spent per month and per year on cigarettes, time spent smoking compared with time spent doing other daily tasks, and how the participant compares to past study participants in average number of cigarettes per day used and level of addiction. Receives: Behavioral: Personalized Feedback |
| No Feedback- Treatment as Usual (TAU) | No intervention | Participants will take the computer based survey, but will only receive a number to the Oklahoma Tobacco Helpline (Treatment-as-usual condition) instead of feedback. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Readiness and Motivation to Quit Smoking
We will assess changes in self-reported readiness and motivation to quit smoking.
Measured: Baseline, 1-month, 6-months, 12-months
Parent and Child Salivary Cotinine
We will assess change in parent and child salivary cotinine throughout the course of the study.
Measured: Baseline, 1-month, 6-months, and 12-months
Change in self-reported cigarette use
We will assess changes in self-reported cigarette use throughout the study.
Measured: baseline, 1-month, 6-months, and 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Smoking BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Oklahoma Center for the Advancement of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Stephen Gillaspy, Ph.D., Principal investigator, The University of Oklahoma Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01921439
- Sponsor's protocol ID
- 3262
- Acronym
- OCAST
- Status last verified
- Apr 2017
- First submitted
- 8 Aug 2013
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Matching Brief Smoking Interventions to Stage of Change
- ClinicalTrials.gov ID
- NCT01921439
- Acronym / sponsor ID
- OCAST / 3262
- Conditions
- Tobacco Smoking Behavior, Cigarette Smoking Behavior, Second Hand Tobacco Smoke, Tobacco Use Cessation
- Keywords
- smoking, quit smoking, smoking cessation, smoking study, secondhand smoke, smokers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Oklahoma Center for the Advancement of Science and Technology
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The long-term goal is to improve the quality of life of children and their parents who smoke tobacco by facilitating parental smoking cessation in a way that is easy to administer yet effective. We aim to accomplish this goal by administering an interactive computer-based program that will facilitate motivation and readiness to engage in smoking cessation by providing personalized feedback about the financial and health effects of the parent's smoking. We will compare the changes in motivation and readiness to quit smoking after the parent has taken the computer-based program and compare them to the changes in motivation and readiness to quit in parents who receive only information about the Oklahoma Tobacco Helpline. We will also measure salivary cotinine levels in both parents and children, to objectively measure changes in smoking habits and secondhand smoke exposure. Our hypothesis is that our computer-based program will cause a greater increase in motivation and confidence to quit smoking in the group that receives the customized feedback than the group that receives only information about the Tobacco Helpline. We also predict that both parent and child cotinine levels will show a greater decrease in the group randomized to receive personalized feedback.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback | Active comparator | Behavioral: Personalized FeedbackParticipants in this group will receive individualized feedback based on their stage of change. Feedback will include health effects of smoking, money spent per month and per year on cigarettes, time spent smoking compared with time spent doing other daily tasks, and how the participant compares to past study participants in average number of cigarettes per day used and level of addiction. |
| No Feedback- Treatment as Usual (TAU) | No intervention | –Participants will take the computer based survey, but will only receive a number to the Oklahoma Tobacco Helpline (Treatment-as-usual condition) instead of feedback. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent or primary caregiver of a child patient at the OU Children's Physicians General Pediatrics clinics
- Current cigarette user
- Able to read study forms and verbally communicate with the study staff in English
Key exclusion criteria (2 listed)
- Nonsmokers
- Unable to read or speak English well enough to complete the survey and study tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized FeedbackPersonalized feedback reflecting the participant's current level of nicotine addiction, money spent on cigarettes, time spent smoking, and health effects of smoking. | Behavioural | Feedback |
Primary outcome
Self-Reported Readiness and Motivation to Quit Smoking
Time frame: Baseline, 1-month, 6-months, 12-months
We will assess changes in self-reported readiness and motivation to quit smoking.
Parent and Child Salivary Cotinine
Time frame: Baseline, 1-month, 6-months, and 12-months
We will assess change in parent and child salivary cotinine throughout the course of the study.
Change in self-reported cigarette use
Time frame: baseline, 1-month, 6-months, and 12-months
We will assess changes in self-reported cigarette use throughout the study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Gillaspy, Ph.D. principal investigator
The University of Oklahoma Health Sciences Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized Feedback in people with Tobacco Smoking Behavior and Cigarette Smoking Behavior, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Readiness and Motivation to Quit Smoking (time frame: Baseline, 1-month, 6-months, 12-months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.