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Recruiting NCT07420621

Preliminary Effectiveness of Enhanced Text Message + Incentives

No phase Interventional Smoking Cessation Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Text Messages, Incentives.
Who it may be relevant to
Registry conditions: Smoking Cessation, Pregnancy. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Preliminary Studies on Implementation of Smoking Cessation Interventions for Low-Income Women

Overview

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).

Detailed description

Pregnant women who smoke and their babies are exposed to known carcinogens and smoking is associated with adverse maternal and birth outcomes. Low-income pregnant women are particularly at risk because they have higher smoking rates and are less likely to quit. Despite continued smoking, most pregnant smokers do not receive smoking cessation counseling and only one in 10 receive referrals to cessation services or follow-up care. Incentives for smoking cessation yield the highest effect sizes of any intervention for pregnant women. Most prior studies evaluating incentives for smoking cessation in this population have used time and resource-intensive in-person visits to verify abstinence for contingent reinforcement. The long-term goal of this research is to reduce the burden of tobacco use by developing and evaluating a highly scalable, effective intervention to support smoking cessation during pregnancy.

Interventions

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

Primary outcome measures

  • Feasibility of Intervention [Time frame: 12 weeks post-randomization]
  • Smoking Abstinence [Time frame: 12 weeks post-randomization]
  • Acceptability of Intervention [Time frame: 12 weeks post-randomization]
Secondary outcome measures (1)
  • Smoking Abstinence [Time frame: 26 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Kansas Medical Center — Kansas City

Identifiers

NCT: NCT07420621 · STUDY00149204

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗