Quit4Baby Evaluation (Quit4Baby)

February 25, 2016 updated by: Lorien Abroms, George Washington University

Developing and Scaling a Text Messaging Tool to Help Pregnant Smokers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

505

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 44 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
quit4baby + text4baby
Behavioral: Quit4Baby
Behavioral: Text4Baby
Other: Control
text4baby
Behavioral: Text4Baby

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biometrically confirmed abstinence
Time Frame: 3-6 months
With saliva cotinine
3-6 months
Quitline call rates
Time Frame: 1-6 months
1-6 months
Knowledge as measured by survey items
Time Frame: 1-6 months
1-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

March 31, 2015

First Submitted That Met QC Criteria

April 8, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R44 DA035017-0 2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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