Clinical trial NCT02602730: Internet-Based Nonsmoking Program for Postpartum Women
Official title: Internet-Based Nonsmoking Program for Postpartum Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cigarette Smoking
Smoking, Tobacco
Keywords: Cigarette smoking
Smoking, Tobacco
postpartum
internet
interactive
coach
Lead sponsor: Oregon Center for Applied Science, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-11
Enrollment: 307
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

Eligibility criteria: Inclusion criteria for pregnant:

* 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.

Inclusion criteria for general population participants:

* Male or female not pregnant
* 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

Exclusion critieria:

* 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.

Primary outcomes:
measure: Change from baseline in number of cigarettes smoked in the last 7 days
timeFrame: 10 months
Secondary outcomes:
measure: Change from baseline in knowledge of impact of smoking cessation
timeFrame: 10 months
measure: Change from baseline in self-efficacy to quit smoking
timeFrame: 10 months
measure: Change from baseline in attitudes about smoking cessation
timeFrame: 10 months
measure: Change from baseline in behavioral intentions about smoking cessation
timeFrame: 10 months
measure: Program satisfaction
timeFrame: 4-week posttest
measure: User rating of system usability
timeFrame: 4-week posttest
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Center for Applied Science
state: Oregon
Study officials:
affiliation: Oregon Center for Applied Science
name: Susan W Schroeder, MPH, MCHES
role: PRINCIPAL_INVESTIGATOR
References: