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Completed

NCT Number: NCT05041413

Helping Moms Quit Pilot Trial

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Moms Quit

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Days abstinent in the past 30 days

    Time frame: 12 weeks post-randomization

    Self-reported abstinence in the past 30 days

Secondary outcomes

  1. 7 day point prevalence abstinence

    Time frame: 12 weeks post-randomization

    Biochemically verified 7 day point prevalence abstinence using salivary cotinine with a 13ng/ml cut off

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2021
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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