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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02412956
Other study ID # R15CA167586
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2013
Est. completion date August 2016

Study information

Verified date October 2021
Source George Washington University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 13 Years to 44 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SmokefreeMOM Text


Locations

Country Name City State
United States Medstar Hospital Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Smoking Abstinence 7-day point prevalence abstinence measured by Self-Report and Confirmed with Saliva Cotinine 3 months
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