NCT02412865

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
505

participants targeted

Target at P75+ for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Last Updated

February 26, 2016

Status Verified

February 1, 2016

Enrollment Period

10 months

First QC Date

March 31, 2015

Last Update Submit

February 25, 2016

Conditions

Smoking CessationPregnancy

Keywords

mhealth

Outcome Measures

Primary Outcomes (3)

  • Biometrically confirmed abstinence

    With saliva cotinine

    3-6 months

  • Quitline call rates

    1-6 months

  • Knowledge as measured by survey items

    1-6 months

Study Arms (2)

Intervention

EXPERIMENTAL

quit4baby + text4baby

Behavioral: Quit4BabyBehavioral: Text4Baby

Control

OTHER

text4baby

Behavioral: Text4Baby

Interventions

Quit4BabyBEHAVIORAL
Intervention
Text4BabyBEHAVIORAL
ControlIntervention

Eligibility Criteria

Age14 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • years old or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The George Washington University

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

Location

Related Publications (2)

  • 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.

    PMID: 25650765BACKGROUND

  • 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.

    PMID: 32813276DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 9, 2015

Study Start

April 1, 2015

Primary Completion

February 1, 2016

Last Updated

February 26, 2016

Record last verified: 2016-02

Locations

US(1)