Helping Moms Quit Pilot Trial

Smoking Cessation Clinical Trial

Official title:

Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041413
• Other study ID #: K01DA040745_1
• Secondary ID: K01DA040745
• Status: Completed
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Smoking Cessation

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