Pregnancy, Smoking, Smoking Cessation
Conditions
Keywords
Pregnancy, Smoking, Smoking cessation
Brief summary
Our goal is to study self-monitoring of smoking as a means to reduce smoking in pregnant women. Investigators hypothesize that more regular self-monitoring, text messages and feedback as provided by home carbon monoxide monitoring device combined with medical feedback on results will reduce smoking during pregnancy compared to only receiving text message and no self-monitoring by home monitoring device and no feedback by home carbon monoxide monitoring device . The periconceptual period is a life period, where given the immediacy of the fetus and future child, a pregnant woman is willing to try and modify potentially harmful behaviors.
Detailed description
Altering unhealthy behaviors, such as tobacco smoking, that increase cardiovascular disease and cancer risk, has proven remarkably difficult in traditional medical practice settings, and successful medical trials have been costly and labor intensive. This proposal aims to utilize a self-monitoring device, i.e., carbon monoxide monitor to foster smoking cessation among pregnant women who smoke. Investigators hypothesize that women who have access to a self-monitoring device more frequently (i.e., at home) and receive feedback about their carbon monoxide level will have greater reductions in smoking as determined by declining serum cotinine levels over the course of the study compared to women who do not have access to a self-monitoring device and do not receive feedback about their carbon monoxide level, but only receive text messages.
Interventions
DEVICEpiCO+ Smokerlyzer® monitor
OTHERText messages
Sponsors
Penn State University
Milton S. Hershey Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women 18-40 years old * Participants will be pregnant women estimated to be between 6 and 20 weeks into their pregnancy * Pregnant women have smoked at least at least one cigarette in the prior 7 days * Own a smartphone capable of delivering and receiving text messages
Exclusion criteria
* Project materials and text messages are in English, potential participants will be excluded if they cannot read English and if there are concerns about the ability to comprehend or comply with study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome of Serum Cotinine Levels | 1 year | The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm A no CO monitor | 1 |
| Arm B CO monitor | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | miscarriage | 1 | 0 |
Baseline characteristics
| Characteristic | Arm A | Total |
|---|---|---|
| Age, Continuous | 32 years | 32 years |
| Gender Female | 1 Participants | 1 Participants |
| Gender Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Primary Outcome of Serum Cotinine Levels
The primary outcome is the difference in serum cotinine levels between the intervention and control groups at the end of the trial.
Time frame: 1 year
Population: Only 1 subject enrolled in this study and she terminated early due to miscarriage at 9 weeks.