Pregnancy, Smoking Cessation
Conditions
Keywords
mHealth
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.
Interventions
BEHAVIORALSmokefreeMOM Text
Sponsors
George Washington University
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
13 Years to 44 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Abstinence | 3 months | 7-day point prevalence abstinence measured by Self-Report and Confirmed with Saliva Cotinine |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Pamphlet | 44 |
| Intervention SmokefreeMOM text messaging program and SmokefreeMOM text messaging program+ Quitline | 55 |
| Total | 99 |
Baseline characteristics
| Characteristic | Total | Control | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 99 Participants | 44 Participants | 55 Participants |
| Age, Continuous | 27.66 years STANDARD_DEVIATION 4.9 | 28.25 years STANDARD_DEVIATION 4.78 | 27.18 years STANDARD_DEVIATION 4.98 |
| Region of Enrollment United States | 99 participants | 44 participants | 55 participants |
| Sex: Female, Male Female | 99 Participants | 44 Participants | 55 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 55 |
| other Total, other adverse events | 0 / 44 | 0 / 55 |
| serious Total, serious adverse events | 0 / 44 | 0 / 55 |
Outcome results
Primary
Smoking Abstinence
7-day point prevalence abstinence measured by Self-Report and Confirmed with Saliva Cotinine
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Smoking Abstinence | 4 participants |
| Intervention | Smoking Abstinence | 8 participants |