SmokefreeMOM: Reaching Pregnant Smokers With Health Information Via Text Messaging

• Sponsor: George Washington University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02412956
• Collaborator: (none)
• Enrollment: 99
• Location: 1
• Arms: 3
• Duration (Months): 43
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy; Smoking Cessation	Behavioral: SmokefreeMOM Text	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 99 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Quit4Baby: Reaching Pregnant Smokers With Health Information Via Text
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Aug 1, 2016
• Actual Study Completion Date: Aug 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Control pamphlet
Experimental: Intervention (text) SmokefreeMOM text messaging program	Behavioral: SmokefreeMOM Text
Experimental: Intervention Plus (text+quitline) SmokefreeMOM text messaging program + state quitline	Behavioral: SmokefreeMOM Text

Outcome Measures

Primary Outcome Measures

1. Smoking Abstinence [3 months]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. pregnant,

2. smoke or quit in the past 2 weeks,

3. has a data plan or an unlimited text messaging plan on her cell in order to avoid charges for texts,

4. an English speaker.

Exclusion Criteria:

1. not pregnant

2. not currently smoking (or within past 2 weeks)

3. not able to receive text messages

4. not an English speaker

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medstar Hospital	Washington	District of Columbia	United States	20010

Sponsors and Collaborators

• George Washington University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lorien Abroms, Associate Professor, George Washington University
• ClinicalTrials.gov Identifier: NCT02412956
• Other Study ID Numbers: R15CA167586
• First Posted: Apr 9, 2015
• Last Update Posted: Nov 26, 2021
• Last Verified: Oct 1, 2021

• Keywords provided by Lorien Abroms, Associate Professor, George Washington University: mHealth

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from 11 obstetrics-gynecology clinics from 9/5/14 to 5/25/16; 9 from Medstar Health, one GWU MFA, and the other Capital Women's Care. The recruitment occurred via the electronic medical record as smokers and pregnant and sent a letter about the study. Subjects were recruited by physicians at the time of visit and were called by study staff.

Arm/Group Title	Control	Intervention (Text)	Intervention Plus (Text+Quitline)
Arm/Group Description	pamphlet	SmokefreeMOM text messaging program SmokefreeMOM Text	SmokefreeMOM text messaging program + state quitline SmokefreeMOM Text
Period Title: Overall Study
STARTED	44	47	8
COMPLETED	35	30	8
NOT COMPLETED	9	17	0

Baseline Characteristics

Arm/Group Title	Control	Intervention	Total
Arm/Group Description	Pamphlet	SmokefreeMOM text messaging program and SmokefreeMOM text messaging program+ Quitline	Total of all reporting groups
Overall Participants	44	55	99
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	44 100%	55 100%	99 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.25 (4.78)	27.18 (4.98)	27.66 (4.90)
Sex: Female, Male (Count of Participants)
Female	44 100%	55 100%	99 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	44 100%	55 100%	99 100%

Outcome Measures

1. Primary Outcome

Title	Smoking Abstinence
Description	7-day point prevalence abstinence measured by Self-Report and Confirmed with Saliva Cotinine
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Control	Intervention
Arm/Group Description	pamphlet	SmokefreeMOM text messaging program and SmokefreeMOM text messaging program + state quitline
Measure Participants	44	55
Number [participants]	4 9.1%	8 14.5%

Adverse Events

Arm/Group Title	Control		Intervention
Arm/Group Description	pamphlet		SmokefreeMOM text messaging program and SmokefreeMOM text messaging program + state quitline
All Cause Mortality
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/55 (0%)
Serious Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/55 (0%)
Other (Not Including Serious) Adverse Events
	Control		Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/55 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.