Cigarette SmokingPhase 2PostPartum_2NCT02602730
Internet-Based Nonsmoking Program for Postpartum Women
A Phase 2 study testing Break the Chain and Clearing the Air in people with Cigarette Smoking and Smoking, Tobacco, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
Trial summary
This project developed and evaluated an Internet-based interactive program with digital coaching designed to assist two groups of smokers in quitting smoking: (1) pregnant smokers and (2) general-population smokers (i.e., men and non-pregnant women). Program content was based on the U.S. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cigarette Smoking, Smoking, Tobacco
- What is being tested?
- Break the Chain and Clearing the Air
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 307 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Aug 2013
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Between 8 and 32 weeks pregnant
- Currently smoking, trying to quit, or quit smoking within last 2 months
- Able to speak and read English
- Have access to high-speed or DSL Internet and email for the duration of the study.
- Male or female not pregnant
Show all 10Show fewer
- 18 years or older
- Currently smoking, trying to quit, or quit smoking within last 2 months
- Able to speak and read English
- Have access to high-speed or DSL Internet and email for the duration of the study
Who cannot join
- Men and women under age 18 were excluded.
- Women who were pregnant but whose pregnancy did not fit within the specified time frame were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Center for Applied Science
Eugene, Oregon, 97401
About this study
This project developed and evaluated an Internet-based interactive program with digital coaching designed to assist two groups of smokers in quitting smoking: (1) pregnant smokers and (2) general-population smokers (i.e., men and non-pregnant women). Program content was based on the U.S. Department of Health and Human Services Clinical Practice Guidelines, "Treating Tobacco Use and Dependence: 2008 Update" (Fiore et al., 2008) and input from project consultants.
Read the detailed description
The "Break the Chain" program is an online smoking cessation intervention that incorporated strategic message construction based on behavior change constructs, interactive exercises, and digitial coaching support to engage the user in their smoking behavior change. The Expanded Theory of Reasoned Action (ETRA) (Fishbein, 1999, 2000) provides the theoretical foundation for the content. Intervention components include: (1) interactive check-ins, (2) content modules and interactive smoking cessation tools, (3) digital coaching, and (4) online social media (i.e., article feed).
Content modules included: Benefits of quitting, Making a plan for quitting, Boosting your support system, Planning for cravings and tempting situations, Managing stress and mood, Managing your weight, and Becoming an ex-smoker. Tailored information within each module was presented to the user based on responses to initial assessment questions and interactive check-ins (e.g., readiness to quit, pregnancy status, previous quit attempts, self-efficacy for quitting, worry about weight gain). Interactive tools presented within the logical flow of the modules included a Reasons for Quitting questionnaire, Pros and Cons of Quitting tool (decisional balance), Nicotine Dependence quiz, a Pharmacological Aid Decision tool, and a Quit Meter. Content was entirely text-based.
Within-program coach-generated and program-generated messages provided cessation tips and information. Digital coaching contacts were timed and tailored to the user's smoking status, health history, pregnancy status (if appropriate), and timing of quit day. The coaching messages prompted the user to engage more fully with the website by presenting hyperlinks to pertinent smoking cessation information or strategies in the program. A computer algorithm controlled the timing of the messages to each user. Users were invited to contact their coach via in-program message at any time with questions or concerns about smoking cessation strategies. A coaching interface allowed a health coach to view user information as the user progressed through the program and developed his/her quit plan. The coaching interface was also the platform through which the coach managed communication with each user.
- Conditions
- Cigarette Smoking, Smoking, Tobacco
- Being tested
- Break the Chain, Clearing the Air
- Keywords
- Cigarette smoking, Smoking, Tobacco, postpartum, internet, interactive, coach
- Medical subject headings
- Cigarette Smoking, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Break the ChainBehavioural
Internet-based smoking cessation intervention designed for general population smokers with targeted materials for pregnant women. The program included a digital coaching component delivered via email at specific points as the user progresses through his/her quit process. Program content is based on Department of Health and Human Services Clinical Practice Guidelines for Treating Tobacco Use and Dependence.
Clearing the AirBehavioural
PDF version of smoking cessation booklet from National Cancer Institute.
| Study group | Role | What they receive |
|---|---|---|
| Break the Chain | Experimental | Access during the evaluation study period to an Internet smoking cessation intervention that included digital coaching messages sent at prescribed times during the participant's quit process and as needed in response to participant questions or comments. Receives: Behavioral: Break the Chain |
| Clearing the Air PDF | Active comparator | Control users were e-mailed a copy of the National Cancer Institute's PDF smoking cessation booklet, "Clearing the Air." Receives: Behavioral: Clearing the Air |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in number of cigarettes smoked in the last 7 days
Smoking cessation as measured by number of cigarettes smoked in the last 7 days. We will use an intent-to-treat statistical analysis, a conservative approach that classifies all non-responders as smokers.
Measured: 10 months
Secondary outcomes (6)
Change from baseline in knowledge of impact of smoking cessation
Pregnant smokers only: Eight knowledge items assess post-natal impact (e.g., Smoking during pregnancy increases chances of having a child who develops asthma); seven items assess infant impact (e.g., Exposing an infant to smoke in the home increases the chances the baby will wake up at night more than usual); eight items assessed infant health risk (e.g., Babies exposed to secondhand smoke have increased chances of having learning disabilities). Response options were a "true" and "false" format scored to reflect the proportion of items answered correct in each domain. The seriousness of infant health issues related to smoking was assessed with five items (e.g., A baby born with lower than normal weight - low birth weight baby) with a five-point response option (1=not at all serious, 5=extremely serious). A mean score was computed and it showed good reliability (alpha = .82).
Measured: 10 months
Change from baseline in self-efficacy to quit smoking
Six self-efficacy items (e.g., How confident are you that you could quit and stay quit) were assessed of all smokers. Each item had a five-point response option (1=not at all confident, 5=extremely confident) and showed good reliability (alpha=.86).
Measured: 10 months
Change from baseline in attitudes about smoking cessation
Five attitude items (e.g., Knowing the right way to ask for help from family and friends when I'm quitting is important) were assessed of all smokers. Each item had a five-point response option (1=not at all important, 5=extremely important) and showed adequate reliability (alpha=.77).
Measured: 10 months
Change from baseline in behavioral intentions about smoking cessation
Five intention items (e.g., How likely is it that you will avoid every situation where you will be tempted to smoke) were assessed of all smokers. Each item had a five-point response option (1=not at all likely, 5=extremely likely) and showed adequate reliability (alpha = .79).
Measured: 10 months
Program satisfaction
Seven program satisfaction items were assessed of as rated by the treatment participants at the T2 assessment. Treatment participants were also asked how likely they would be to recommend the program to a friend and/or family member.
Measured: 4-week posttest
User rating of system usability
All treatment participants were asked how much they agreed or disagreed with program usability statements (see Table 3) with response options on a 5- point scale (1 = strongly disagree, 2 = disagree, 3 = neither disagree or agree, 4 = agree 5 = strongly agree). The SUS is a tool designed for assessing the usability of a product and has been normed across numerous platforms (e.g., Web sites, cell phones, TV applications). Scores range from 0 to 100. (SUS; Bangor, Kortum, \& Miller, 2009)
Measured: 4-week posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startFeb 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies 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 2
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 307 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Center for Applied Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Susan Schroeder, Oregon Center for Applied Science, Inc.
- Investigators
- Susan W Schroeder, MPH, MCHES, Principal investigator, Oregon Center for Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602730
- Sponsor's protocol ID
- SBIR80RR-II
- Other IDs
- R44CA112739-01A2
- Acronym
- PostPartum_2
- Status last verified
- Nov 2015
- First submitted
- 2 Jan 2015
- Last updated
- 11 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Based Nonsmoking Program for Postpartum Women
- ClinicalTrials.gov ID
- NCT02602730
- Acronym / sponsor ID
- PostPartum_2 / SBIR80RR-II
- Conditions
- Cigarette Smoking, Smoking, Tobacco
- Keywords
- Cigarette smoking, Smoking, Tobacco, postpartum, internet, interactive, coach
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 307 participants (actual)
- Lead sponsor
- Oregon Center for Applied Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Nov 2015 (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.
This project developed and evaluated an Internet-based interactive program with digital coaching designed to assist two groups of smokers in quitting smoking: (1) pregnant smokers and (2) general-population smokers (i.e., men and non-pregnant women). Program content was based on the U.S. Department of Health and Human Services Clinical Practice Guidelines, "Treating Tobacco Use and Dependence: 2008 Update" (Fiore et al., 2008) and input from project consultants.
Detailed description
The "Break the Chain" program is an online smoking cessation intervention that incorporated strategic message construction based on behavior change constructs, interactive exercises, and digitial coaching support to engage the user in their smoking behavior change. The Expanded Theory of Reasoned Action (ETRA) (Fishbein, 1999, 2000) provides the theoretical foundation for the content. Intervention components include: (1) interactive check-ins, (2) content modules and interactive smoking cessation tools, (3) digital coaching, and (4) online social media (i.e., article feed).
Content modules included: Benefits of quitting, Making a plan for quitting, Boosting your support system, Planning for cravings and tempting situations, Managing stress and mood, Managing your weight, and Becoming an ex-smoker. Tailored information within each module was presented to the user based on responses to initial assessment questions and interactive check-ins (e.g., readiness to quit, pregnancy status, previous quit attempts, self-efficacy for quitting, worry about weight gain). Interactive tools presented within the logical flow of the modules included a Reasons for Quitting questionnaire, Pros and Cons of Quitting tool (decisional balance), Nicotine Dependence quiz, a Pharmacological Aid Decision tool, and a Quit Meter. Content was entirely text-based.
Within-program coach-generated and program-generated messages provided cessation tips and information. Digital coaching contacts were timed and tailored to the user's smoking status, health history, pregnancy status (if appropriate), and timing of quit day. The coaching messages prompted the user to engage more fully with the website by presenting hyperlinks to pertinent smoking cessation information or strategies in the program. A computer algorithm controlled the timing of the messages to each user. Users were invited to contact their coach via in-program message at any time with questions or concerns about smoking cessation strategies. A coaching interface allowed a health coach to view user information as the user progressed through the program and developed his/her quit plan. The coaching interface was also the platform through which the coach managed communication with each user.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Break the Chain | Experimental | Behavioral: Break the ChainAccess during the evaluation study period to an Internet smoking cessation intervention that included digital coaching messages sent at prescribed times during the participant's quit process and as needed in response to participant questions or comments. |
| Clearing the Air PDF | Active comparator | Behavioral: Clearing the AirControl users were e-mailed a copy of the National Cancer Institute's PDF smoking cessation booklet, "Clearing the Air." |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years or older
- Between 8 and 32 weeks pregnant
- Currently smoking, trying to quit, or quit smoking within last 2 months
- Able to speak and read English
- Have access to high-speed or DSL Internet and email for the duration of the study.
Key exclusion criteria (2 listed)
- Men and women under age 18 were excluded.
- Women who were pregnant but whose pregnancy did not fit within the specified time frame were excluded.
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 |
|---|---|---|
| Break the ChainInternet-based smoking cessation intervention designed for general population smokers with targeted materials for pregnant women. The program included a digital coaching component delivered via email at specific points as the user progresses through his/her quit process. Program content is based on Department of Health and Human Services Clinical Practice Guidelines for Treating Tobacco Use and Dependence. | Behavioural | Break the Chain |
| Clearing the AirPDF version of smoking cessation booklet from National Cancer Institute. | Behavioural | Clearing the Air PDF |
Primary outcome
Change from baseline in number of cigarettes smoked in the last 7 days
Time frame: 10 months
Smoking cessation as measured by number of cigarettes smoked in the last 7 days. We will use an intent-to-treat statistical analysis, a conservative approach that classifies all non-responders as smokers.
6 secondary outcomes
Change from baseline in knowledge of impact of smoking cessation
Time frame: 10 months
Change from baseline in self-efficacy to quit smoking
Time frame: 10 months
Change from baseline in attitudes about smoking cessation
Time frame: 10 months
Change from baseline in behavioral intentions about smoking cessation
Time frame: 10 months
Program satisfaction
Time frame: 4-week posttest
User rating of system usability
Time frame: 4-week posttest
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 Nov 2015.
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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.
Susan W Schroeder, MPH, MCHES principal investigator
Oregon Center for Applied Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Break the Chain and Clearing the Air in people with Cigarette Smoking and Smoking, Tobacco, run by Oregon Center for Applied Science, Inc. 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 10 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 Nov 2015. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in number of cigarettes smoked in the last 7 days (time frame: 10 months). 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 Nov 2015; AzTrials last refreshed its copy on 28 Oct 2026.