Trial Outcomes & Findings for SmokefreeMOM: Reaching Pregnant Smokers With Health Information Via Text Messaging (NCT NCT02412956)

NCT ID: NCT02412956

Last Updated: 2021-11-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 99 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-11-26

Participant Flow

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.

Participant milestones

Measure	Control pamphlet	Intervention (Text) SmokefreeMOM text messaging program SmokefreeMOM Text	Intervention Plus (Text+Quitline) SmokefreeMOM text messaging program + state quitline SmokefreeMOM Text
Overall Study STARTED	44	47	8
Overall Study COMPLETED	35	30	8
Overall Study NOT COMPLETED	9	17	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SmokefreeMOM: Reaching Pregnant Smokers With Health Information Via Text Messaging

Baseline characteristics by cohort

Measure	Control n=44 Participants Pamphlet	Intervention n=55 Participants SmokefreeMOM text messaging program and SmokefreeMOM text messaging program+ Quitline	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants	55 Participants n=7 Participants	99 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.25 years STANDARD_DEVIATION 4.78 • n=5 Participants	27.18 years STANDARD_DEVIATION 4.98 • n=7 Participants	27.66 years STANDARD_DEVIATION 4.90 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	55 Participants n=7 Participants	99 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	44 participants n=5 Participants	55 participants n=7 Participants	99 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

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

Outcome measures

Measure	Control n=44 Participants pamphlet	Intervention n=55 Participants SmokefreeMOM text messaging program and SmokefreeMOM text messaging program + state quitline
Smoking Abstinence	4 participants	8 participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lorien Abroms

The George Washington University

Email: lorien@gwu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place