Quit4Baby Evaluation

Not Applicable

Completed

• Conditions: Pregnancy; Smoking Cessation
• Interventions: Behavioral: Quit4Baby; Behavioral: Text4Baby

• Registration Number: NCT02412865
• Lead Sponsor: George Washington University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-31
• Study Start: 2015-04
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-09
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Last Update Submitted: 2016-02-25
• Last Update Posted: 2016-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 505

Inclusion Criteria

1. Subscribe to the text4baby test messaging program
2. Pregnant
3. 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.
4. Speak English
5. Willing to enroll in our study
6. 14 years old or older

Exclusion Criteria

1. No longer subscribe to text4baby
2. Not pregnant
3. Not current smoker (within past 2 weeks)
4. Non-English speakers
5. Not willing to receive Quit4Baby messages or enroll in study
6. Younger than 14 years of age

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention	Quit4Baby	quit4baby + text4baby
Control	Text4Baby	text4baby
Intervention	Text4Baby	quit4baby + text4baby

Primary Outcome Measures

Name	Time	Method
Knowledge as measured by survey items	1-6 months
Biometrically confirmed abstinence	3-6 months	With saliva cotinine
Quitline call rates	1-6 months

Trial Locations

Locations (1)

The George Washington University; 🇺🇸 Washington, District of Columbia, United States