NCT05041413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 11, 2021

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 2, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
Last Updated

November 4, 2022

Status Verified

November 1, 2022

Enrollment Period

1.2 years

First QC Date

September 2, 2021

Last Update Submit

November 1, 2022

Conditions

Keywords

Postpartum women

Outcome Measures

Primary Outcomes (1)

  • Days abstinent in the past 30 days

    Self-reported abstinence in the past 30 days

    12 weeks post-randomization

Secondary Outcomes (1)

  • 7 day point prevalence abstinence

    12 weeks post-randomization

Study Arms (2)

Moms Quit Intervention

EXPERIMENTAL

12 weeks of the Moms Quit text message intervention

Behavioral: Moms Quit

Text4Baby

ACTIVE COMPARATOR

12 weeks of Text4Baby messages

Behavioral: Text4Baby

Interventions

Moms QuitBEHAVIORAL

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.

Moms Quit Intervention
Text4BabyBEHAVIORAL

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.

Text4Baby

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2021

First Posted

September 13, 2021

Study Start

August 11, 2021

Primary Completion

October 5, 2022

Study Completion

October 5, 2022

Last Updated

November 4, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations