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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05041413
Other study ID # K01DA040745_1
Secondary ID K01DA040745
Status Completed
Phase N/A
First received
Last updated
Start date August 11, 2021
Est. completion date October 5, 2022

Study information

Verified date November 2022
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to test the feasibility and preliminary effectiveness of a tailored text message program to support smoking abstinence among postpartum women who smoke or recently quit.


Description:

This pilot trial will evaluate a text message intervention (Moms Quit) to be initiated with postpartum women within one month of delivery. Moms Quit is a tailored program to support smoking abstinence among new mothers who are either current smokers or quit during their most recent pregnancy. Investigators will randomize 30 postpartum women, stratified by recent/current smoking status, into Moms Quit versus vs. CONTROL. Investigators hypothesize that participants receiving Moms Quit will have, on average, a significantly longer period of self-reported prolonged abstinence compared to CONTROL.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 5, 2022
Est. primary completion date October 5, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Less than one month postpartum - Live delivery - Smoked at least 100 cigarettes/lifetime - Smoked anytime during their most recent pregnancy - English-speaking - Own a mobile phone - Provide an email address - Willing to receive intervention-related texts - Willing to complete surveys - Willing to provide a saliva sample at the end of the study Exclusion Criteria: - Women whose pregnancy did not result in live birth - On a 7-point scale, participant indicates that they are not interested in quitting or staying quit in the next 6 months (Not at all = 1).

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Moms Quit
Participants will receive text messages tailored on (1) current smoking status and (2) intention to quit/remain quit. Message content includes supportive messaging for child and self-care, relapse prevention, and smoking cessation. Women who are ready to quit will receive messages from the SmokeFreeText library.
Text4Baby
Text4Baby is a free, publicly available text messaging program that provides information about nutrition, safe sleep tips, baby's milestones, signs and symptoms of labor, doctor visit and appointment reminders, breastfeeding advice, car seat safety, information on health insurance, urgent health alerts, and resource hotlines and websites.

Locations

Country Name City State
United States University of Kansas Medical Center Kansas City Kansas

Sponsors (2)

Lead Sponsor Collaborator
University of Kansas Medical Center National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Days abstinent in the past 30 days Self-reported abstinence in the past 30 days 12 weeks post-randomization
Secondary 7 day point prevalence abstinence Biochemically verified 7 day point prevalence abstinence using salivary cotinine with a 13ng/ml cut off 12 weeks post-randomization
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