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CompletedNCT02412865Quit4BabyUpdated Feb 26, 2016

Quit4Baby Evaluation

An interventional study of Quit4Baby and Text4Baby in Smoking Cessation and Pregnancy, sponsored by George Washington University. Completed at 1 site in United States. Open to female participants aged 14 Years to 44 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-26.

Sponsored by George Washington University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
505
Allocation
Randomized
Ages
14 Years to 44 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Smoking Cessation
  • Pregnancy

Keywords

  • mhealth
03

In context

Lead sponsor

George Washington University is the lead sponsor of 187 studies on the registry; 34 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
505 participants (actual)

Study arms

  • Experimental
    Intervention

    quit4baby + text4baby

    Behavioral: Quit4Baby · Behavioral: Text4Baby

  • Other
    Control

    text4baby

    Behavioral: Text4Baby

Interventions

  • BehavioralQuit4Baby
  • BehavioralText4Baby
06

What researchers measure

Primary outcomes

  1. Biometrically confirmed abstinence

    With saliva cotinine

    Time frame: 3-6 months

  2. Quitline call rates

    Time frame: 1-6 months

  3. Knowledge as measured by survey items

    Time frame: 1-6 months

07

Study locations

1 site
  • The George Washington University
    Washington, District of Columbia 20052, United States
08

References and documents

Publications

  • 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. PubMed 25650765 ↗
  • 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. PubMed 32813276 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02412865
Lead sponsor
George Washington University
Responsible party
Lorien Abroms (Associate Professor, George Washington University) — Principal investigator
First posted
Apr 9, 2015
Start date
Apr 2015
Primary completion
Feb 2016
Last update
Feb 26, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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