Self-Monitoring of Carbon Monoxide to Enhance Reproductive Outcomes in Women

Penn State Health

Status: Terminated

Conditions: Smoking; Smoking Cessation; Pregnancy

Treatments: Device: piCO+ Smokerlyzer® monitor; Other: Text messages

Study type: Interventional

Funder types: Other

Identifiers

NCT02246114

STUDY00000370

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1 participants in 2 patient groups

no CO monitor

Experimental group

Description:

Not given a piCO+ Smokerlyzer® monitor, will receive daily text messages.

Treatment:

Other: Text messages

CO monitor

Experimental group

Description:

Given a piCO+ Smokerlyzer® monitor, will receive daily text messages, will receive feedback about the relative level of carbon monoxide.

Treatment:

Other: Text messages

Device: piCO+ Smokerlyzer® monitor