Quit4Baby Evaluation

Pregnancy Clinical Trial

— Quit4Baby  

Official title:

Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02412865
• Other study ID #: R44 DA035017-0 2
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: February 25, 2016
• Start date: April 2015

Study information

• Verified date: February 2016
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 505
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 44 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pregnancy
• Smoking Cessation

Intervention

Behavioral:
• Quit4Baby

• Text4Baby

Locations

Country	Name	City	State
United States	The George Washington University	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Abroms LC, Johnson PR, Heminger CL, Van Alstyne JM, Leavitt LE, Schindler-Ruwisch JM, Bushar JA. Quit4baby: results from a pilot test of a mobile smoking cessation program for pregnant women. JMIR Mhealth Uhealth. 2015 Jan 23;3(1):e10. doi: 10.2196/mhealth.3846. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biometrically confirmed abstinence	With saliva cotinine	3-6 months	No
Primary	Quitline call rates		1-6 months	No
Primary	Knowledge as measured by survey items		1-6 months	No