Clinical trial · Interventional
Increasing Access to Smoking Cessation and Smoke Free Home Services for Low-Income Pregnant Women in Northeast Texas
NCT05051345CI-TRIAL-00111760terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): \< 75% participation
Summary
Brief summary (as posted)
This trial seeks to increase access to smoking cessation services to low-income pregnant women. Smoking is associated with an increased risk of developing cancer. Smoking during pregnancy smoking is associated with an increased risk of low birth weight, a condition that is associated with neonatal, perinatal, and infant morbidity and mortality. The overall goal of this trial is to help patients make healthy choices and provide support during pregnancy and in the first few months after the birth of the baby.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cigarette Smoking-Related Carcinoma | Cigarette Smoking-Related Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Informational Intervention | Other | — | UNRESOLVED |
| Media Intervention | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Smoking Cessation Intervention | Behavioral | — | UNRESOLVED |
| Survey Administration | Other | — | UNRESOLVED |
| Telephone-Based Intervention | Behavioral | — | UNRESOLVED |
| Tobacco Cessation Counseling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Goal 1 (Wellness app)
- description
- Participants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation.
- interventionNames
- Other: Informational Intervention
- Other: Media Intervention
- Other: Questionnaire Administration
- Other: Survey Administration
- type
- EXPERIMENTAL
- label
- Goal 2 (counseling, Wellness app, self-help)
- description
- Participants receive telephone counseling sessions over 30-45 minutes for a minimum of 6 sessions in the prenatal period and about 4-6 postpartum period. Participants who start counseling after birth, may receive 6-8 sessions up to 4 months postpartum. Participants may also use the Pregnancy and Wellness smartphone app that provides wellness messages, smoking cessation information, relapse prevention tips, and tips to create a smoke-free home. Participants also receive tobacco cessation self-help materials including National Partnership for Smoke Free Families and Forever Free Baby and Me.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * PRE-TEST SURVEY FOR PREGNANT WOMEN: Currently pregnant * PRE-TEST SURVEY FOR PREGNANT WOMEN: Currently receiving services at one of the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) or Federally Qualified Health Centers (FQHC) clinics listed in the protocol * PRE-TEST SURVEY FOR PREGNANT WOMEN: Self-report being a current smoker, having quit for the pregnancy or allowing smoking in the home * PRE-TEST SURVEY FOR PREGNANT WOMEN: Reside in Texas * PRE-TEST SURVEY FOR PREGNANT WOMEN: Consent to take surveys * PRE-TEST SURVEY FOR PREGNANT WOMEN: English or Spanish speaking * SERVICES OFFERED TO PREGNANT WOMEN: Currently pregnant or within the first 4 months of postpartum period * SERVICES OFFERED TO PREGNANT WOMEN: Self-report that they are currently receiving services at one of the WIC or FQHC clinics listed in the protocol * SERVICES OFFERED TO PREGNANT WOMEN: Self-report being a current smoker, having quit for the pregnancy or allowing smoking in the home * SERVICES OFFERED TO PREGNANT WOMEN: Reside in Texas * SERVICES OFFERED TO PREGNANT WOMEN: Willing to provide address, telephone contact or download app onto their smartphones * SERVICES OFFERED TO PREGNANT WOMEN: English or Spanish speaking * HOUSEHOLD MEMBERS OF PREGNANT WOMEN: Self-report that he/she currently smokes and lives in the household with the pregnant woman who is receiving services * HOUSEHOLD MEMBERS OF PREGNANT WOMEN: Reside in Texas * HOUSEHOLD MEMBERS OF PREGNANT WOMEN: English or Spanish speaking * SERVICES OFFERED TO NON-PREGNANT INDIVIDUALS: Currently receiving services at one of the WIC or FQHC clinics listed in the protocol * SERVICES OFFERED TO NON-PREGNANT INDIVIDUALS: Self-report being a current smoker or allowing smoking in the home * SERVICES OFFERED TO NON-PREGNANT INDIVIDUALS: Reside in Texas * SERVICES OFFERED TO NON-PREGNANT INDIVIDUALS: English or Spanish speaking
References
Publications (0)
Data not yet available
No reference posted for this study.