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

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05051345
• Other study ID #: 2018-0901
• Secondary ID: NCI-2020-0733820
• Status: Recruiting
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: February 2, 2027

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Jan Blalock
• Phone: 713-745-1728
• Email: jablaloc[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54158
• Est. completion date: February 2, 2027
• Est. primary completion date: February 2, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Other:
• Informational Intervention
Receive information on the services provided for pregnant women and smoking cessation
• Informational Intervention
Receive tobacco cessation self-help materials
• Informational Intervention
Receive Smoke-Free Homes mailings
• Media Intervention
Download and use the Wellness app
• 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
• Telephone-Based Intervention
Receive a coaching call from a Baby Steps for Health counselor

Other:
• Tobacco Cessation Counseling
Receive telephone counseling sessions

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To provide proactive referral to services to participants		Through study completion, an average of 1 year

External Links

•   University of Texas MD Anderson Cancer Center Website