NCT05051345

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 191 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. Establish proactive referral to services. II. Provide access to evidence-based counseling and app-based smoking cessation, relapse prevention services, and counseling to household members of pregnant women who smoke III. Provide access to smoke free homes intervention. IV. Provide access to evidence-based counseling for non-pregnant smokers and access to smoke free homes intervention for non-pregnant individuals who have smoking in the home. OUTLINE: GOAL 1: Participants download and use the Wellness app onto their smartphones. Participants also receive information on the services provided for pregnant women and smoking cessation. GOAL 2: 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. GOAL 3: 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. GOAL 4: Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period.

Conditions

• Cigarette Smoking-Related Carcinoma

Interventions

Type	Name	Description
OTHER	Informational Intervention	Receive information on the services provided for pregnant women and smoking cessation
OTHER	Informational Intervention	Receive tobacco cessation self-help materials
OTHER	Informational Intervention	Receive Smoke-Free Homes mailings
OTHER	Media Intervention	Download and use the Wellness app
OTHER	Questionnaire Administration	Ancillary studies
BEHAVIORAL	Smoking Cessation Intervention	Receive Smoke-Free Homes kit
OTHER	Survey Administration	Ancillary studies
BEHAVIORAL	Telephone-Based Intervention	Receive telephone counseling sessions
BEHAVIORAL	Telephone-Based Intervention	Receive a coaching call from a Baby Steps for Health counselor
OTHER	Tobacco Cessation Counseling	Receive telephone counseling sessions

Timeline

• Start date: 2020-02-18
• Primary completion: 2027-02-02
• Completion: 2027-02-02
• First posted: 2021-09-21
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States