Increasing Access to Smoking Cessation and Smoke Free Home Services for Low-Income Pregnant Women in Northeast Texas
NCT ID: NCT05051345
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
54158 participants
INTERVENTIONAL
2020-02-18
2027-02-02
Brief Summary
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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
Informational Intervention
Receive information on the services provided for pregnant women and smoking cessation
Media Intervention
Download and use the Wellness app
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
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.
Informational Intervention
Receive tobacco cessation self-help materials
Media Intervention
Download and use the Wellness app
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Telephone-Based Intervention
Receive telephone counseling sessions
Tobacco Cessation Counseling
Receive telephone counseling sessions
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.
Informational Intervention
Receive Smoke-Free Homes mailings
Questionnaire Administration
Ancillary studies
Smoking Cessation Intervention
Receive Smoke-Free Homes kit
Survey Administration
Ancillary studies
Telephone-Based Intervention
Receive a coaching call from a Baby Steps for Health counselor
Goal 4 (counseling)
Non-pregnant participants receive telephone counseling sessions over 30 minutes for 6-8 sessions over a 3 month period.
Questionnaire Administration
Ancillary studies
Survey Administration
Ancillary studies
Telephone-Based Intervention
Receive telephone counseling sessions
Tobacco Cessation Counseling
Receive telephone counseling sessions
Interventions
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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
Smoking Cessation Intervention
Receive Smoke-Free Homes kit
Survey Administration
Ancillary studies
Telephone-Based Intervention
Receive telephone counseling sessions
Telephone-Based Intervention
Receive a coaching call from a Baby Steps for Health counselor
Tobacco Cessation Counseling
Receive telephone counseling sessions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jan Blalock
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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NCI-2020-07338
Identifier Type: REGISTRY
Identifier Source: secondary_id
2018-0901
Identifier Type: OTHER
Identifier Source: secondary_id
2018-0901
Identifier Type: -
Identifier Source: org_study_id
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