NCT07420621

Brief Summary

This study is a preliminary evaluation of a smoking cessation intervention designed for pregnant women that combines text message support and financial incentives. The aims of this study are to determine the preliminary feasibility and acceptability of text message + incentives (intervention) vs. text message only (control).

Trial Health

77
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
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress59%
Apr 2026Aug 2026

First Submitted

Initial submission to the registry

February 12, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 9, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Expected
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

February 12, 2026

Last Update Submit

April 13, 2026

Conditions

Keywords

Smoking CessationMaternal Health

Outcome Measures

Primary Outcomes (2)

  • Feasibility of Intervention

    Retention rate.

    4 weeks post-randomization

  • Acceptability of Intervention

    Participant ratings of acceptability.

    4 weeks post-randomization

Secondary Outcomes (1)

  • Smoking Abstinence

    4 weeks post-randomization

Study Arms (2)

Text Messaging + Incentives

EXPERIMENTAL

Participants in this arm will receive a combination of text messages designed to support smoking cessation and escalating financial incentives contingent on biochemically-verified smoking abstinence (exhaled carbon monoxide).

Behavioral: Text MessagesBehavioral: Incentives

Text Messaging Only

ACTIVE COMPARATOR

Participants in this arm will receive the same text messaging program as in Arm 1, but without the financial incentives contingent on abstinence.

Behavioral: Text Messages

Interventions

Text MessagesBEHAVIORAL

Intervention Component - Text messages (SmokeFreeTXT library with pregnancy related messages) participants will receive scheduled messages to support quitting and prevent relapse.

Text Messaging + IncentivesText Messaging Only
IncentivesBEHAVIORAL

Incentives for abstinence - Weeks 1-4; 8; 12: Twice daily CO assessments with verification sent via text-message. Participants will receive daily incentives ranging each day of smoking abstinence.

Text Messaging + Incentives

Eligibility Criteria

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

You may qualify if:

  • Pregnant women aged: 18+
  • Enrolled in the Special Supplemental Nutrition Program for women, Infants, and Children (WIC) or Medicaid (or applied/applying)
  • Self-reported current daily smokers
  • Able to communicate in English
  • Access to a mobile phone capable of receiving text messages

You may not qualify if:

  • Not at all interested in quitting
  • Smoke less than 24 days in the past month
  • Greater than 30 weeks gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Fertility

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

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

February 12, 2026

First Posted

February 19, 2026

Study Start

April 9, 2026

Primary Completion

June 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations