Path2Quit Tobacco Intervention For African Americans

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

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-01

Study Completion Date

2018-08-20

Brief Summary

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The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.

The study includes completing surveys and receiving text messages to help participants become tobacco free.

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Detailed Description

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OBJECTIVES Specific Aim 1: Translate a culturally specific video-based tobacco use intervention into a scalable mobile health (mhealth) format.

Specific Aim 2: Conduct a pilot study of the video-text intervention.

Study Design:

2-arm semi-pragmatic randomized design among current tobacco users

Cuyahoga Metropolitan Housing Authority residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT). Primary outcomes will include intervention evaluations (content and format), acceptability, coping strategies, engagement, and NRT adherence. Secondary variables will include 24-hour quit attempts and biochemically verified tobacco use abstinence at the 1-month follow-up. Exploratory mediational analyses will examine the roles of urban hassles, acculturation, neighborhood environment, ethnic discrimination, and psychological distress in intervention effects.

Conditions

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Smoking Cessation Smoking, Tobacco

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

We will conduct a 2-arm semi-pragmatic randomized design among current tobacco users (N=100). CMHA residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT).

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Path2Quit

Culturally specific text message intervention

Group Type EXPERIMENTAL

Path2Quit

Intervention Type BEHAVIORAL

Path2Quit will deliver 20-60 second video clips by multimedia messaging service. The message library will include 75-170 messages. Written text messages will be limited to brief phrases to indicate the topic of the video. Messages will be pushed to participants in the morning, in the afternoon, and 2 hours before the reported usual bedtime. The cultural adaptations will be infused throughout the video segments. Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.

SmokeFreeText

The National Cancer Institute's publicly available, standard text messaging program for tobacco cessation

Group Type ACTIVE_COMPARATOR

SmokeFreeText

Intervention Type BEHAVIORAL

SmokefreeTXT is a 6-8 week fully automated text-based cessation intervention. The program is free to U.S. subscribers who have a mobile phone, and is available on smokefree.gov or by texting "QUIT" to short code 47848. Participants are encouraged to set a quit date within the next 14 days, followed by count-down messages leading to the quit date. Starting on the quit date, participants receive 6 weeks of intervention text messages, and assessment questions (mood, cravings, smoking status). The message library contains 166 messages and 41 behavior change techniques,40 which are delivered at the greatest frequency during the first 2 weeks and taper over time. When in need of assistance, participants can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system. Participants can opt-out by texting STOP at any time. With informed consent, we will be able to access the SmokefreeTXT data for these participants.

Interventions

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SmokeFreeText

SmokefreeTXT is a 6-8 week fully automated text-based cessation intervention. The program is free to U.S. subscribers who have a mobile phone, and is available on smokefree.gov or by texting "QUIT" to short code 47848. Participants are encouraged to set a quit date within the next 14 days, followed by count-down messages leading to the quit date. Starting on the quit date, participants receive 6 weeks of intervention text messages, and assessment questions (mood, cravings, smoking status). The message library contains 166 messages and 41 behavior change techniques,40 which are delivered at the greatest frequency during the first 2 weeks and taper over time. When in need of assistance, participants can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system. Participants can opt-out by texting STOP at any time. With informed consent, we will be able to access the SmokefreeTXT data for these participants.

Intervention Type BEHAVIORAL

Path2Quit

Path2Quit will deliver 20-60 second video clips by multimedia messaging service. The message library will include 75-170 messages. Written text messages will be limited to brief phrases to indicate the topic of the video. Messages will be pushed to participants in the morning, in the afternoon, and 2 hours before the reported usual bedtime. The cultural adaptations will be infused throughout the video segments. Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.

Intervention Type BEHAVIORAL

Other Intervention Names

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SmokefreeTXT

Eligibility Criteria

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Inclusion Criteria

* Self-identify as African American
* Either smoke at least 1 cigarettes/day or have a carbon monoxide (CO) reading of at least 4 ppm
* Consistent with SmokefreeTXT, be willing to set a quit date within the next 14 days.
* Recruited from Cleveland metropolitan housing authority or who report low income based on federal guidelines

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes