Clinical trial NCT06438549: Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation
Official title: Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation: A Pilot Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: University of California, San Francisco
name: Riverside University Health System Medical Center
First posted: 2024-06-03
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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

Detailed description: This study seeks to address the disparities in the maternal smoking cessation outcomes of previous research by developing an innovative maternal tobacco cessation program that expands the outreach by integrating home visits by community health workers (CHW) into the prenatal healthcare model. The overall aim is to conduct a pilot randomized control trial to test the feasibility, acceptability, and efficacy of a Healthcare Provider-Community Health Worker (HCP-CHW) intervention model that expands outreach by adding eight home visits by CHWs to provide tobacco cessation support services before and after the quit date.

Eligibility criteria: 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

Primary outcomes:
measure: Self-Report Tobacco Abstinence
timeFrame: Change between baseline enrollment and 1 month postpartum visit, typically ten months
Secondary outcomes:
measure: Carbon Monoxide Level
timeFrame: Change between baseline and 1 month postpartum visit, typically ten months
measure: Arm 1 Satisfaction with CHW visit
timeFrame: Baseline; during the intervention; through study completion, an average of 10 months.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
city: Moreno Valley
country: United States
facility: Riverside University Health Systems
state: California
Study officials:
affiliation: Loma Linda University
name: Anne Berit Petersen, PhD
role: PRINCIPAL_INVESTIGATOR
References: