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

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Cigarette Smoking-Related Carcinoma

Treatments

Other: Media Intervention

Behavioral: Smoking Cessation Intervention

Other: Questionnaire Administration

Other: Tobacco Cessation Counseling

Behavioral: Telephone-Based Intervention

Other: Survey Administration

Other: Informational Intervention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT05051345

2018-0901 (Other Identifier)

NCI-2020-07338 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

54,158 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

54,158 participants in 4 patient groups

Goal 1 (Wellness app)

Experimental group

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.

Treatment:

Other: Informational Intervention

Other: Survey Administration

Other: Informational Intervention

Other: Questionnaire Administration

Other: Media Intervention

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

Experimental group

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.

Treatment:

Behavioral: Telephone-Based Intervention

Other: Informational Intervention

Other: Survey Administration

Other: Informational Intervention

Other: Tobacco Cessation Counseling

Behavioral: Telephone-Based Intervention

Other: Questionnaire Administration

Other: Media Intervention

Goal 3 (Smoke-free Homes)

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone-Based Intervention

Other: Informational Intervention

Other: Survey Administration

Other: Informational Intervention

Behavioral: Telephone-Based Intervention

Other: Questionnaire Administration

Behavioral: Smoking Cessation Intervention

Goal 4 (counseling)

Experimental group

Description:

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