An interventional study of HCP-CHW Integration into Prenatal Care for Smoking Cessation and Control Arm in Tobacco Use, Tobacco Use Cessation and Tobacco Use in Childbirth, sponsored by Loma Linda University. Recruiting at 2 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-08.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.
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.
125 studies on the registry are indexed under Tobacco Use; 64 are open to participants now.
This study's planned enrollment of 105 is below the median of 150 across 119 interventional studies indexed under Tobacco Use.
Browse Tobacco Use studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
CHW visit with brief tobacco cessation intervention.
Behavioral: HCP-CHW Integration into Prenatal Care for Smoking Cessation
Standard of Care
Other: Control Arm
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.
Standard of Care which provides referrals to community-based smoking cessation resources.
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
Time frame: Change between baseline enrollment and 1 month postpartum visit, typically ten months
Carbon Monoxide Level
Breathalyzer test will be administered to subjects to determine CO level. Subjects will then be classified per CO level as: Nonsmoker = 0 to 3 Borderline = 4 to 6 Smoker = 7 and above Smoker Low Addiction = 7 to 10 Smoker Moderate Addiction = 11 to 15 Smoker Heavily Addicted = 16 to 25 Smoker Very heavily Addicted = 26+
Time frame: Change between baseline and 1 month postpartum visit, typically ten months
Arm 1 Satisfaction with CHW visit
The acceptability of the intervention will be assessed using composite Likert scale measures of process outcomes such as 1) overall patient satisfaction, 2) increasing patient motivation and confidence, and 3) willingness to recommend the program to others. Likert scale interpretations for overall satisfaction: 1=Very Dissatisfied; 2=Dissatisfied; 3=Neutral; 4=Satisfied; 5=Very Satisfied. Likert scale interpretation for patient motivation and confidence: 1=Strongly Disagree (The intervention did not increase motivation/confidence at all); 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree (The intervention significantly increased motivation/confidence). Likert scale interpretation for Willingness to Recommend the Program to Others: 1=Not at all likely; 2=Unlikely; 3=Neutral; 4=Likely; 5=Very Likely.
Time frame: Baseline; during the intervention; through study completion, an average of 10 months.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Loma Linda University