Clinical trial NCT02412865: Quit4Baby Evaluation
Official title: Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Pregnancy
Keywords: mhealth
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 505
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 44
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Biometrically confirmed abstinence
timeFrame: 3-6 months
measure: Quitline call rates
timeFrame: 1-6 months
measure: Knowledge as measured by survey items
timeFrame: 1-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: The George Washington University
state: District of Columbia
Study officials:
References:
citation: 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.
citation: Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.