Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation

NCT06438549 | Recruiting DMC

• 2 other identifiers: 5220112T32KT4784
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 2

Brief Summary

This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.

Conditions

Tobacco Use; Tobacco Use Cessation; Tobacco Use in Childbirth

Keywords

prevention; treatment; disparities and social inequality; tobacco use cessation; community health worker; pregnant smokers

Outcome Measures

Primary Outcomes (1)

• Self-Report Tobacco Abstinence

  The 7 Day Point Prevalence Abstinence (PPA) questionnaire will be administered to subjects to assess the following: Tobacco use within past seven days

  Change between baseline enrollment and 1 month postpartum visit, typically ten months

Secondary Outcomes (2)

• Carbon Monoxide Level

  Change between baseline and 1 month postpartum visit, typically ten months

• Arm 1 Satisfaction with CHW visit

  Baseline; during the intervention; through study completion, an average of 10 months.

Study Arms (2)

Integrated HCP-CHW Intervention Arm

EXPERIMENTAL

CHW visit with brief tobacco cessation intervention.

Behavioral: HCP-CHW Integration into Prenatal Care for Smoking Cessation

Control arm

OTHER

Standard of Care

Other: Control Arm

Interventions

HCP-CHW Integration into Prenatal Care for Smoking Cessation BEHAVIORAL

CHWs will be integrated into primary care, and subjects will receive CHW home visits (up to 8) that will provide brief behavioral smoking cessation interventions before, during, and after a quit date. This brief behavioral intervention will include watching a video and reviewing self-help materials.

Integrated HCP-CHW Intervention Arm

Control Arm OTHER

Standard of Care which provides referrals to community-based smoking cessation resources.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 24 weeks pregnant
• age \> 18 years,
• current smokers (100 cigarettes in their lifetime and \>3 cigarettes per day in the last 7 days; including poly-tobacco use, combining cigarettes with non-combustible products) confirmed by expired carbon monoxide (CO)
• willing to quit smoking and set a quit date in the next 2 weeks upon enrolling
• enrolled in prenatal care at Loma Linda University Health (LLUH) or Riverside University Health System (RUHS)

You may not qualify if:

• severe mental health problems that prevent informed consent and/or CHW intervention
• women who were on Nicotine Replacement Therapy (NRT) or enrolled in a cessation program within 30 days
• unwillingness to participate in audio-recorded key informant interviews or focus groups

Sponsors & Collaborators

• Loma Linda University: lead
• University of California, San Francisco: collaborator
• Riverside University Health System Medical Center: collaborator

Study Sites (2)

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

RECRUITING

Riverside University Health Systems

Moreno Valley, California, 92555, United States

NOT YET RECRUITING

Related Links

• Study website

MeSH Terms

Conditions

Tobacco Use; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Behavior; Health Behavior

Study Officials

• Anne Berit Petersen, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne Berit Petersen

CONTACT

909 558 1000; abpetersen@llu.edu

Pramil Singh

CONTACT

psingh@llu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The model compares the integration of CHW Home visits into healthcare provider-directed clinical care and a schedule of CHW home visits to provide behavioral smoking cessation for pregnant people and adult household members before, during, and after a quit date vs Standard of Care.

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: June 3, 2024
• Study Start: May 24, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (2)