Recruiting

Prenatal Care

Sponsor:

Loma Linda University

Code:

NCT06438549

Conditions

Tobacco Use

Tobacco Use Cessation

Tobacco Use in Childbirth

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HCP-CHW Integration into Prenatal Care for Smoking Cessation

Control Arm

Study Details

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

Study ID

NCT06438549

Start date

May 24, 2024

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • < 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Integrated HCP-CHW Intervention Arm

CHW visit with brief tobacco cessation intervention.

other: Control arm

Standard of Care

Interventions

HCP-CHW Integration into Prenatal Care for Smoking Cessation

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.

Control Arm

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

Primary outcome measure

  • Self-Report Tobacco Abstinence [ Time Frame: Change between baseline enrollment and 1 month postpartum visit, typically ten months ]

Central Contacts and Locations

Central contacts

Anne Berit Petersen

909 558 1000abpetersen@llu.edu

Pramil Singh

psingh@llu.edu

Locations

Loma Linda University Medical Center

Recruiting

Loma Linda, California, United States, 92350

Contacts

Courtney Martin, DO

909-558-1000COUMartin@llu.edu

More Information

Sponsor

Loma Linda University

Last update posted

Jun 8, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Loma Linda University on 2026-06-08.