Internet-Based Nonsmoking Program for Postpartum Women

NCT ID: NCT02602730

Last Updated: 2015-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

307 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-08-31

Brief Summary

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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

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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

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Cigarette Smoking Smoking, Tobacco

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Break the Chain

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.

Group Type EXPERIMENTAL

Break the Chain

Intervention Type BEHAVIORAL

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 Air PDF

Control users were e-mailed a copy of the National Cancer Institute's PDF smoking cessation booklet, "Clearing the Air."

Group Type ACTIVE_COMPARATOR

Clearing the Air

Intervention Type BEHAVIORAL

PDF version of smoking cessation booklet from National Cancer Institute.

Interventions

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Break the Chain

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.

Intervention Type BEHAVIORAL

Clearing the Air

PDF version of smoking cessation booklet from National Cancer Institute.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Oregon Center for Applied Science, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Susan Schroeder

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan W Schroeder, MPH, MCHES

Role: PRINCIPAL_INVESTIGATOR

Oregon Center for Applied Science

Locations

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Oregon Center for Applied Science

Eugene, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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R44CA112739-01A2

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SBIR80RR-II

Identifier Type: -

Identifier Source: org_study_id

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