Increasing Access to Smoking Cessation and Smoke Free Home Services for Low-Income Pregnant Women in Northeast Texas

NCT05051345 | Terminated

• 2 other identifiers: 2018-0901NCI-2020-07338
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

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

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• To provide proactive referral to services to participants

  Through study completion, an average of 1 year

Study Arms (4)

Goal 1 (Wellness app)

EXPERIMENTAL

Participants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation.

Other: Informational Intervention; Other: Media Intervention; Other: Questionnaire Administration; Other: Survey Administration

Goal 2 (counseling, Wellness app, self-help)

EXPERIMENTAL

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.

Other: Informational Intervention; Other: Media Intervention; Other: Questionnaire Administration; Other: Survey Administration; Behavioral: Telephone-Based Intervention; Other: Tobacco Cessation Counseling

Goal 3 (Smoke-free Homes)

EXPERIMENTAL

Participants receive the Smoke-Free Homes kit providing guidance for how to talk with household members and visitors about not smoking inside the home. Participants may also receive 3 separate Smoke-Free Homes mailings over 6 weeks, and a coaching call from a Baby Steps for Health counselor to help follow the steps described in the mailed materials in order to set up a smoke-free home.

Other: Informational Intervention; Other: Questionnaire Administration; Behavioral: Smoking Cessation Intervention; Other: Survey Administration; Behavioral: Telephone-Based Intervention

Goal 4 (counseling)

EXPERIMENTAL

Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period.

Other: Questionnaire Administration; Other: Survey Administration; Behavioral: Telephone-Based Intervention; Other: Tobacco Cessation Counseling

Interventions

Informational Intervention OTHER

Receive information on the services provided for pregnant women and smoking cessation

Goal 1 (Wellness app)

Smoking Cessation Intervention BEHAVIORAL

Receive Smoke-Free Homes kit

Also known as: Smoking and Tobacco Use Cessation Interventions

Goal 3 (Smoke-free Homes)

Survey Administration OTHER

Ancillary studies

Goal 1 (Wellness app); Goal 2 (counseling, Wellness app, self-help); Goal 3 (Smoke-free Homes); Goal 4 (counseling)

Telephone-Based Intervention BEHAVIORAL

Receive telephone counseling sessions

Goal 2 (counseling, Wellness app, self-help); Goal 4 (counseling)

Tobacco Cessation Counseling OTHER

Receive telephone counseling sessions

Goal 2 (counseling, Wellness app, self-help); Goal 4 (counseling)

Questionnaire Administration OTHER

Ancillary studies

Goal 1 (Wellness app); Goal 2 (counseling, Wellness app, self-help); Goal 3 (Smoke-free Homes); Goal 4 (counseling)

Media Intervention OTHER

Download and use the Wellness app

Goal 1 (Wellness app); Goal 2 (counseling, Wellness app, self-help)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Interventions

Smoking Devices

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Jan Blalock

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: September 21, 2021
• Study Start: February 18, 2020
• Primary Completion: May 8, 2026
• Study Completion: May 8, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Locations

US (1)