Quit4Baby Evaluation

Study Overview
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Brief Summary
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The goal of this project is to evaluate the effectiveness (Phase II) of a text-based program to be called Quit4Baby to support smoking cessation efforts of pregnant women who smoke. In Phase II, Dr. Abroms will conduct a randomized clinical trial among 500 pregnant smokers who have been recruited from users of text4baby - the first large scale mobile health application in the United States. Developed and operated by Voxiva and Healthy Mothers, Healthy Babies (HMHB)-collaborators in this program -text4baby is a free national service that has enrolled more than 800,000 pregnant women and mothers of infants 0-1 nationwide and delivered more than 150 million health messages to them including messages encouraging them not to smoke during pregnancy and referring them to quit lines. Hypothesis 1: Pregnant smokers who receive quit4Baby + text4Baby will demonstrate higher levels of knowledge about the dangers of second hand smoke and the benefits of smoking cessation for mothers and their infants than text4baby only users. Hypothesis 2: Pregnant smokers who receive quit4baby + text4baby will report significantly higher rates of calling a quit line, discussions with their health provider and/or use of cessation counseling than those who receive Text4baby alone. Hypothesis 3: Pregnant smokers who receive quit4baby + text4baby will have significantly more favorable quitting outcomes compared with text4baby alone.

Official Title
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Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers

Conditions
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Smoking Cessation, Pregnancy

Intervention / Treatment
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* Behavioral: Quit4Baby
* Behavioral: Text4Baby


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subscribe to the text4baby test messaging program Pregnant Smoke or recently quit (within last 2 weeks)- Smoking will be defined as self-report of smoking at least one cigarette in the past 7 days. Given that these individuals are recruited from text4baby users, we are confident that they will have cell phones and text messaging capacity. Speak English Willing to enroll in our study 14 years old or older Exclusion Criteria: No longer subscribe to text4baby Not pregnant Not current smoker (within past 2 weeks) Non-English speakers Not willing to receive Quit4Baby messages or enroll in study Younger than 14 years of age

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>quit4baby + text4baby | Behavioral: Quit4Baby<br> <br> Behavioral: Text4Baby<br> <br> |
| Other: Control<br>text4baby | Behavioral: Text4Baby<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biometrically confirmed abstinence | With saliva cotinine | 3-6 months | 
| Quitline call rates |  | 1-6 months | 
| Knowledge as measured by survey items |  | 1-6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mhealth