SmokefreeMOM: Reaching Pregnant Smokers With Health Information Via Text Messaging

Study Overview
=================
Brief Summary
-----------------
Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.

Official Title
-----------------
Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text

Conditions
-----------------
Pregnancy, Smoking Cessation

Intervention / Treatment
-----------------
* Behavioral: SmokefreeMOM Text


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant, smoke or quit in the past 2 weeks, has a data plan or an unlimited text messaging plan on her cell in order to avoid charges for texts, an English speaker. Exclusion Criteria: not pregnant not currently smoking (or within past 2 weeks) not able to receive text messages not an English speaker

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>pamphlet | |
| Experimental: Intervention (text)<br>SmokefreeMOM text messaging program | Behavioral: SmokefreeMOM Text<br> <br> |
| Experimental: Intervention Plus (text+quitline)<br>SmokefreeMOM text messaging program + state quitline | Behavioral: SmokefreeMOM Text<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Abstinence | 7-day point prevalence abstinence measured by Self-Report and Confirmed with Saliva Cotinine | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mHealth