Helping Moms Quit Pilot Trial

Study Overview
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Brief Summary
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The objective of this study is to test the feasibility and preliminary effectiveness of a tailored text message program to support smoking abstinence among postpartum women who smoke or recently quit.

Detailed Description
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This pilot trial will evaluate a text message intervention (Moms Quit) to be initiated with postpartum women within one month of delivery. Moms Quit is a tailored program to support smoking abstinence among new mothers who are either current smokers or quit during their most recent pregnancy. Investigators will randomize 30 postpartum women, stratified by recent/current smoking status, into Moms Quit versus vs. CONTROL. Investigators hypothesize that participants receiving Moms Quit will have, on average, a significantly longer period of self-reported prolonged abstinence compared to CONTROL.

Official Title
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Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Moms Quit
* Behavioral: Text4Baby


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Less than one month postpartum Live delivery Smoked at least 100 cigarettes/lifetime Smoked anytime during their most recent pregnancy English-speaking Own a mobile phone Provide an email address Willing to receive intervention-related texts Willing to complete surveys Willing to provide a saliva sample at the end of the study Exclusion Criteria: Women whose pregnancy did not result in live birth On a 7-point scale, participant indicates that they are not interested in quitting or staying quit in the next 6 months (Not at all = 1).

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moms Quit Intervention<br>12 weeks of the Moms Quit text message intervention | Behavioral: Moms Quit<br>* Participants will receive text messages tailored on (1) current smoking status and (2) intention to quit/remain quit. Message content includes supportive messaging for child and self-care, relapse prevention, and smoking cessation. Women who are ready to quit will receive messages from the SmokeFreeText library.<br>|
| Active Comparator: Text4Baby<br>12 weeks of Text4Baby messages | Behavioral: Text4Baby<br>* Text4Baby is a free, publicly available text messaging program that provides information about nutrition, safe sleep tips, baby's milestones, signs and symptoms of labor, doctor visit and appointment reminders, breastfeeding advice, car seat safety, information on health insurance, urgent health alerts, and resource hotlines and websites.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days abstinent in the past 30 days | Self-reported abstinence in the past 30 days | 12 weeks post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 day point prevalence abstinence | Biochemically verified 7 day point prevalence abstinence using salivary cotinine with a 13ng/ml cut off | 12 weeks post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postpartum women