NCT02412956

Brief Summary

Despite the great health benefits associated with smoking cessation in pregnancy to both mother and baby, few studies to date have examined the applications of text messaging or other communication technologies for smoking cessation in this population. This project is the first step in developing a new dissemination strategy for reaching pregnant smokers. This research will explore how a state-of -the-art, interactive and intensive, text messaging program, SmokefreeMoms Text, can promote smoking cessation in pregnant smokers. This program may have the potential to reach pregnant smokers who are not currently being reached with traditional smoking cessation services. The study Aims are: 1) to elicit qualitative feedback from pregnant smokers and recent quitters (in the past month) about the concept of SmokefreeMoms, the proposed message protocols in SmokefreeMoms, and the proposed messages in SmokefreeMoms (Phase 1); 2) To develop and pilot test a prototype of SmokefreeMoms which is consistent with Clinical Practice Guidelines (Phase 2), and 3) To conduct a formative evaluation of SmokefreeMoms 1.0 with pregnant smokers and recent quitters (Phase 3). 4) To measure the likelihood that pregnant women who smoke cigarettes will join an SMS program by responding to different types of recruitment messages.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable pregnancy

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

Study Start

First participant enrolled

January 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

March 31, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
5.3 years until next milestone

Results Posted

Study results publicly available

November 26, 2021

Completed
Last Updated

November 26, 2021

Status Verified

October 1, 2021

Enrollment Period

3.6 years

First QC Date

March 31, 2015

Results QC Date

October 28, 2021

Last Update Submit

October 28, 2021

Conditions

PregnancySmoking Cessation

Keywords

mHealth

Outcome Measures

Primary Outcomes (1)

  • Smoking Abstinence

    7-day point prevalence abstinence measured by Self-Report and Confirmed with Saliva Cotinine

    3 months

Study Arms (3)

Control

NO INTERVENTION

pamphlet

Intervention (text)

EXPERIMENTAL

SmokefreeMOM text messaging program

Behavioral: SmokefreeMOM Text

Intervention Plus (text+quitline)

EXPERIMENTAL

SmokefreeMOM text messaging program + state quitline

Behavioral: SmokefreeMOM Text

Interventions

SmokefreeMOM TextBEHAVIORAL
Intervention (text)Intervention Plus (text+quitline)

Eligibility Criteria

Age13 Years - 44 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • pregnant,
  • smoke or quit in the past 2 weeks,
  • has a data plan or an unlimited text messaging plan on her cell in order to avoid charges for texts,
  • an English speaker.

You may not qualify if:

  • not pregnant
  • not currently smoking (or within past 2 weeks)
  • not able to receive text messages
  • not an English speaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medstar Hospital

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (2)

  • 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

  • Abroms LC, Chiang S, Macherelli L, Leavitt L, Montgomery M. Assessing the National Cancer Institute's SmokefreeMOM Text-Messaging Program for Pregnant Smokers: Pilot Randomized Trial. J Med Internet Res. 2017 Oct 3;19(10):e333. doi: 10.2196/jmir.8411.

    PMID: 28974483DERIVED

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Results Point of Contact

Title
Dr. Lorien Abroms
Organization
The George Washington University
lorien@gwu.edu

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

January 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 26, 2021

Results First Posted

November 26, 2021

Record last verified: 2021-10

Locations

US(1)