Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HCP-CHW Integration into Prenatal Care for Smoking Cessation, Control Arm.
- Who it may be relevant to
- Registry conditions: Tobacco Use, Tobacco Use Cessation, Tobacco Use in Childbirth. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation: A Pilot Feasibility Study
Overview
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.
Interventions
- Behavioral 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. - Other Control Arm
Standard of Care which provides referrals to community-based smoking cessation resources.
Primary outcome measures
- Self-Report Tobacco Abstinence [Time frame: Change between baseline enrollment and 1 month postpartum visit, typically ten months]
Secondary outcome measures (2)
- Carbon Monoxide Level [Time frame: Change between baseline and 1 month postpartum visit, typically ten months]
- Arm 1 Satisfaction with CHW visit [Time frame: Baseline; during the intervention; through study completion, an average of 10 months.]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Loma Linda University Medical Center — Loma Linda
- Riverside University Health Systems — Moreno Valley
Identifiers
NCT: NCT06438549 · 5220112 · T32KT4784