Quit4Baby Evaluation

NCT ID: NCT02412865

Last Updated: 2016-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 505 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30

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.

Conditions

Smoking Cessation; Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

quit4baby + text4baby

Group Type: EXPERIMENTAL

Quit4Baby

Intervention Type: BEHAVIORAL

Text4Baby

Intervention Type: BEHAVIORAL

Control

text4baby

Group Type: OTHER

Text4Baby

Intervention Type: BEHAVIORAL

Interventions

Quit4Baby

Intervention Type: BEHAVIORAL

Text4Baby

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Lorien Abroms

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The George Washington University

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

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 25650765 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32813276 (View on PubMed)

Other Identifiers

R44DA035017

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R44 DA035017-0 2

Identifier Type: -

Identifier Source: org_study_id