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Completed

NCT Number: NCT02412865

Quit4Baby Evaluation

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Pregnancy

Age range

14 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The George Washington University

Washington D.C., District of Columbia, 20052, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subscribe to the text4baby test messaging program
  • Pregnant
  • 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.
  • Speak English
  • Willing to enroll in our study
  • 14 years old or older

Exclusion criteria

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

Treatment and study plan

Quit4Baby

Behavioral

Text4Baby

Behavioral

Primary outcomes

  1. Biometrically confirmed abstinence

    Time frame: 3-6 months

    With saliva cotinine

  2. Quitline call rates

    Time frame: 1-6 months

  3. Knowledge as measured by survey items

    Time frame: 1-6 months

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Official study title

Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers

Acronym: Quit4Baby

Important dates

Study start
2015
Primary completion
2016
First posted
Apr 9, 2015
Registry last updated
Feb 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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