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

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.

Study Overview

• Status: Recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Other: Survey Administration; Other: Informational Intervention; Other: Informational Intervention; Other: Informational Intervention; Other: Media Intervention; Behavioral: Telephone-Based Intervention; Behavioral: Telephone-Based Intervention; Other: Tobacco Cessation Counseling; Behavioral: Smoking Cessation Intervention

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.

• Study Type: Interventional
• Enrollment (Estimated): 54158
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jan Blalock; Phone Number: 713-745-1728; Email: jablaloc@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Jan Blalock; Phone Number: 713-745-1728; Email: jablaloc@mdanderson.org
      • Principal Investigator: Jan Blalock

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Goal 1 (Wellness app); 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: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; 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
Experimental: Goal 2 (counseling, Wellness app, self-help); 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: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; 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; 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
Experimental: Goal 3 (Smoke-free Homes); 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: Questionnaire Administration; Ancillary studies; Other: Survey Administration; Ancillary studies; 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; Behavioral: Telephone-Based Intervention; Receive telephone counseling sessions; Behavioral: Telephone-Based Intervention; Receive a coaching call from a Baby Steps for Health counselor; Behavioral: Smoking Cessation Intervention; Receive Smoke-Free Homes kit; Other Names: Smoking and Tobacco Use Cessation Interventions
Experimental: Goal 4 (counseling); Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period.	Other: Questionnaire Administration; Ancillary studies; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To provide proactive referral to services to participants	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Jan Blalock, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2027

Study Registration Dates

• First Submitted: October 5, 2020
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2018-0901 (Other Identifier: M D Anderson Cancer Center); NCI-2020-07338 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No