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Helping Moms Quit Pilot Trial

Sponsor
University of Kansas Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05041413
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
30
Enrollment
1
Location
2
Arms
7.6
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Moms Quit
  • Behavioral: Text4Baby
 N/A

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. We will randomize 30 postpartum women, stratified by recent/current smoking status, into Moms Quit versus vs. CONTROL. We hypothesize that participants receiving Moms Quit will have, on average, a significantly longer period of self-reported prolonged abstinence compared to CONTROL.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change
Actual Study Start Date :
Aug 11, 2021
Anticipated Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Mar 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Moms Quit Intervention

12 weeks of the Moms Quit text message 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.
Active Comparator: Text4Baby

12 weeks of Text4Baby messages

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Days abstinent in the past 30 days [12 weeks post-randomization]

    Self-reported abstinence in the past 30 days

Secondary Outcome Measures

  1. 7 day point prevalence abstinence [12 weeks post-randomization]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Kansas Medical Center Kansas City Kansas United States 66160

Sponsors and Collaborators

  • University of Kansas Medical Center
  • National Institute on Drug Abuse (NIDA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT05041413
Other Study ID Numbers:
  • K01DA040745_1
  • K01DA040745
First Posted:
Sep 13, 2021
Last Update Posted:
Sep 13, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Kansas Medical Center
Postpartum women

Study Results

No Results Posted as of Sep 13, 2021