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Helping Moms Quit Pilot Trial

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05041413
Enrollment
30
Registered
2021-09-13
Start date
2021-08-11
Completion date
2022-10-05
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Keywords

Postpartum women

Brief 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.

Detailed 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.

Interventions

BEHAVIORALMoms 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.

BEHAVIORALText4Baby

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.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Kansas Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Days abstinent in the past 30 days12 weeks post-randomizationSelf-reported abstinence in the past 30 days

Secondary

MeasureTime frameDescription
7 day point prevalence abstinence12 weeks post-randomizationBiochemically verified 7 day point prevalence abstinence using salivary cotinine with a 13ng/ml cut off

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026