Tobacco UseSFHOPENCT06438549
Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation
A study testing HCP-CHW Integration into Prenatal Care for Smoking Cessation in people with Tobacco Use and Tobacco Use Cessation, run by Loma Linda University at 2 sites in United States.
Trial summary
This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Tobacco Use, Tobacco Use Cessation, Tobacco Use in Childbirth
- What is being tested?
- HCP-CHW Integration into Prenatal Care for Smoking Cessation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 May 2024to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- < 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pramil Singh contact
United States2 sites, 2 recruiting
- Recruiting
Loma Linda University Medical Center
Loma Linda, California, 92350
Courtney Martin, DO, 909-558-1000 ext. 15504, COUMartin@llu.edu
- Not yet recruiting
Riverside University Health Systems
Moreno Valley, California, 92555
Bryan Oshiro, MD, B.Oshiro@ruhealth.org
About this study
Official title: Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation: A Pilot Feasibility Study
This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.
Read the 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.
- Being tested
- HCP-CHW Integration into Prenatal Care for Smoking Cessation, Control Arm
- Keywords
- prevention, treatment, disparities and social inequality, tobacco use cessation, community health worker, pregnant smokers
- Medical subject headings
- Tobacco Use, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCP-CHW Integration into Prenatal Care for Smoking CessationBehavioural
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 ArmOther
Standard of Care which provides referrals to community-based smoking cessation resources.
| Study group | Role | What they receive |
|---|---|---|
| Integrated HCP-CHW Intervention Arm | Experimental | CHW visit with brief tobacco cessation intervention. Receives: Behavioral: HCP-CHW Integration into Prenatal Care for Smoking Cessation |
| Control arm | Other | Standard of Care Receives: Other: Control Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change between baseline enrollment and 1 month postpartum visit, typically ten months
Secondary outcomes (2)
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+
Measured: 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.
Measured: Baseline; during the intervention; through study completion, an average of 10 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start24 May 2024
- Primary completionMay 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco, Riverside University Health System Medical Center
- Responsible party
- Sponsor
- Investigators
- Anne Berit Petersen, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438549
- Sponsor's protocol ID
- 5220112
- Other IDs
- T32KT4784
- Acronym
- SFHOPE
- Status last verified
- Jun 2026
- First submitted
- 18 Apr 2024
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT06438549
- Acronym / sponsor ID
- SFHOPE / 5220112
- Keywords
- prevention, treatment, disparities and social inequality, tobacco use cessation, community health worker, pregnant smokers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco, Riverside University Health System Medical Center
- Study start
- 24 May 2024 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Integrated HCP-CHW Intervention Arm | Experimental | Behavioral: HCP-CHW Integration into Prenatal Care for Smoking CessationCHW visit with brief tobacco cessation intervention. |
| Control arm | Other | Other: Control ArmStandard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- < 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HCP-CHW Integration into Prenatal Care for Smoking CessationCHWs 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. | Behavioural | Integrated HCP-CHW Intervention Arm |
| Control ArmStandard of Care which provides referrals to community-based smoking cessation resources. | Other | Control arm |
Primary outcome
Self-Report Tobacco Abstinence
Time frame: Change between baseline enrollment and 1 month postpartum visit, typically ten months
The 7 Day Point Prevalence Abstinence (PPA) questionnaire will be administered to subjects to assess the following: Tobacco use within past seven days
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Study websiteLink provided by the sponsor.
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pramil Singh contact
Anne Berit Petersen, PhD principal investigator
Loma Linda University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HCP-CHW Integration into Prenatal Care for Smoking Cessation in people with Tobacco Use and Tobacco Use Cessation, run by Loma Linda University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Berit Petersen (909 558 1000 ext. 42846, abpetersen@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Report Tobacco Abstinence (time frame: Change between baseline enrollment and 1 month postpartum visit, typically ten months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.