NCT03024606

Brief Summary

The investigators propose an 18-month, randomized, open-label evaluation of the impact of texting to pregnant, underserved, cigarette smokers on smoking cessation rates. Patients will be eligible if they have a confirmed pregnancy, are English speaking, at least 18 years of age, are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation, and have a cellular phone that is capable of receiving text messages. Patients will be randomized to either the texting group or control group. A baseline carbon monoxide level will be obtained. The patient, regardless of group, will have the standard of care smoking cessation visit. If the pharmacist, physician, and patient deem that pharmacotherapy is appropriate, patient will receive nicotine replacement therapy patches or bupropion free of charge in 2-week intervals. Patients in the intervention group will receive text messages focused on smoking cessation and pregnancy. Patients will be seen on a bi-weekly schedule to obtain additional vouchers for patches or for bupropion, meet with the pharmacist, and complete a carbon monoxide exhalation test. These visits will be continued until the pharmacotherapy course is complete.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2017

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 24, 2018

Completed
Last Updated

October 24, 2018

Status Verified

October 1, 2018

Enrollment Period

3.3 years

First QC Date

January 13, 2017

Results QC Date

June 14, 2017

Last Update Submit

October 23, 2018

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

  • Exhaled Carbon Monoxide Levels

    self-reported cessation rates at 1 month, as verified by exhaled carbon monoxide levels

    1 month

Study Arms (2)

texting group

ACTIVE COMPARATOR

text messages focused on smoking cessation and pregnancy

Behavioral: text messages focused on smoking cessation and pregnancy

control group

NO INTERVENTION

No text messages

Interventions

text messages focused on smoking cessation and pregnancyBEHAVIORAL

The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.

texting group

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Have a confirmed pregnancy,
  • English speaking,
  • years of age,
  • Are in the preparation stage of change and willing to set a quit date within 30 days and before 35 weeks gestation,
  • Have a cellular phone that is capable of receiving text messages, and be willing to pay for any related fees for testing.
  • Willing and able to commit to the visit schedule

You may not qualify if:

  • Gestational age \> 35 weeks at quit date
  • If subjects are in the pre-contemplative or contemplative stages of change or have already received 30 minute pharmacy education targeted for the quit date in this pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Palmer MJ, Henschke N, Bergman H, Villanueva G, Maayan N, Tamrat T, Mehl GL, Glenton C, Lewin S, Fonhus MS, Free C. Targeted client communication via mobile devices for improving maternal, neonatal, and child health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013679. doi: 10.1002/14651858.CD013679.

    PMID: 32813276DERIVED

  • Forinash AB, Yancey A, Chamness D, Koerner J, Inteso C, Miller C, Gross G, Mathews K. Smoking Cessation Following Text Message Intervention in Pregnant Women. Ann Pharmacother. 2018 Nov;52(11):1109-1116. doi: 10.1177/1060028018780448. Epub 2018 Jun 1.

    PMID: 29857773DERIVED

MeSH Terms

Conditions

Smoking Cessation

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Limitations and Caveats

Due to challenges with recruitment and retention, the study was underpowered to detect statistical differences.

Results Point of Contact

Title
Research Nurse
Organization
Saint Louis University
jathompson@slu.edu
314-977-2090

Study Officials

  • Katherine J Mathews, MD

    St. Louis University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 19, 2017

Study Start

March 1, 2014

Primary Completion

June 14, 2017

Study Completion

June 14, 2017

Last Updated

October 24, 2018

Results First Posted

October 24, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share