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

NCT ID: NCT02246114

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2015-05-31

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.

Conditions

Pregnancy; Smoking; Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

no CO monitor

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

Group Type: EXPERIMENTAL

Text messages

Intervention Type: OTHER

CO monitor

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

Group Type: EXPERIMENTAL

piCO+ Smokerlyzer® monitor

Intervention Type: DEVICE

Text messages

Intervention Type: OTHER

Interventions

piCO+ Smokerlyzer® monitor

Intervention Type: DEVICE

Text messages

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: collaborator

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard S. Legro, M.D.

Professor of Obstetrics and Gynecology and Public Health Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard S Legro, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State College of Medicine

Locations

MS Hershey Medical Center, Penn State College of Medicine

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00000370

Identifier Type: -

Identifier Source: org_study_id