[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06438549":3,"trial-entities:NCT06438549":128,"trial-summary:NCT06438549":131},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":48,"secondary_outcomes":53,"sex":62,"minimum_age":63,"maximum_age":64,"healthy_volunteers":65,"eligibility_criteria":66,"std_ages":78,"locations":81,"central_contacts":110,"overall_officials":119,"references":123,"see_also_links":124},"NCT06438549","5220112","Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation","Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation: A Pilot Feasibility Study","RECRUITING","2027-08","2026-06","2026-06-08","2024-05-24","Loma Linda University","OTHER",true,"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.",[19,20,21],"Tobacco Use","Tobacco Use Cessation","Tobacco Use in Childbirth",[23,24,25,26,27,28],"prevention","treatment","disparities and social inequality","tobacco use cessation","community health worker","pregnant smokers","INTERVENTIONAL","TREATMENT",[32],"NA",{"count":34,"type":35},105,"ESTIMATED",[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41},"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.",[42],"Integrated HCP-CHW Intervention Arm",{"type":14,"name":44,"description":45,"armGroupLabels":46},"Control Arm","Standard of Care which provides referrals to community-based smoking cessation resources.",[47],"Control arm",[49],{"measure":50,"description":51,"timeFrame":52},"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","Change between baseline enrollment and 1 month postpartum visit, typically ten months",[54,58],{"measure":55,"description":56,"timeFrame":57},"Carbon Monoxide Level","Breathalyzer test will be administered to subjects to determine CO level. Subjects will then be classified per CO level as:\n\nNonsmoker = 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+","Change between baseline and 1 month postpartum visit, typically ten months",{"measure":59,"description":60,"timeFrame":61},"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\u002Fconfidence at all); 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree (The intervention significantly increased motivation\u002Fconfidence). 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.","Baseline; during the intervention; through study completion, an average of 10 months.","FEMALE","18 Years",null,false,{"inclusion":67,"exclusion":73,"raw_text":77},[68,69,70,71,72],"\\\u003C 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)",[74,75,76],"severe mental health problems that prevent informed consent and\u002For 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","Inclusion Criteria:\n\n* \\\u003C 24 weeks pregnant\n* age \\> 18 years,\n* 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)\n* willing to quit smoking and set a quit date in the next 2 weeks upon enrolling\n* enrolled in prenatal care at Loma Linda University Health (LLUH) or Riverside University Health System (RUHS)\n\nExclusion Criteria:\n\n* severe mental health problems that prevent informed consent and\u002For CHW intervention\n* women who were on Nicotine Replacement Therapy (NRT) or enrolled in a cessation program within 30 days\n* unwillingness to participate in audio-recorded key informant interviews or focus groups",[79,80],"ADULT","OLDER_ADULT",[82,98],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":95},"Loma Linda University Medical Center","Loma Linda","California","92350","United States",[89],{"name":90,"role":91,"phone":92,"phoneExt":93,"email":94},"Courtney Martin, DO","CONTACT","909-558-1000","15504","COUMartin@llu.edu",{"lat":96,"lon":97},34.04835,-117.26115,{"facility":99,"status":100,"city":101,"state":85,"zip":102,"country":87,"contacts":103,"geoPoint":107},"Riverside University Health Systems","NOT_YET_RECRUITING","Moreno Valley","92555",[104],{"name":105,"role":91,"email":106},"Bryan Oshiro, MD","B.Oshiro@ruhealth.org",{"lat":108,"lon":109},33.93752,-117.23059,[111,116],{"name":112,"role":91,"phone":113,"phoneExt":114,"email":115},"Anne Berit Petersen","909 558 1000","42846","abpetersen@llu.edu",{"name":117,"role":91,"email":118},"Pramil Singh","psingh@llu.edu",[120],{"name":121,"affiliation":13,"role":122},"Anne Berit Petersen, PhD","PRINCIPAL_INVESTIGATOR",[],[125],{"label":126,"url":127},"Study website","https:\u002F\u002Fsmokefreehope.org\u002F",{"nct_id":4,"conditions":129,"biomarkers":130},[19],[],{"nct_id":4,"found":15,"summary":132,"prompt_version":142},{"design":133,"status":134,"heading":135,"summary":136,"follow_up":137,"word_count":138,"commitments":139,"compensation":140,"drugs_mentioned":141},"This is an interventional study with a planned enrollment of 105 participants. It is a pilot randomized controlled trial, meaning participants will be randomly assigned to one of the two groups.","completed","Integrating Community Health Workers into Prenatal Care for Smoking Cessation","This study is testing a new approach to help pregnant women in San Bernardino County stop smoking. It compares standard care, which offers referrals to smoking cessation resources, with a program called \"HCP-CHW Integration into Prenatal Care for Smoking Cessation.\" This program adds home visits (up to 8) from Community Health Workers (CHWs) who provide support and materials to help you quit smoking before, during, and after a quit date. You may be able to join if you are a woman over 18, less than 24 weeks pregnant, currently smoke, are willing to quit, and are enrolled in prenatal care. Success for this study means participants report they have stopped smoking between baseline and one month after giving birth. The current recruitment status is unclear.","Participants will be followed to measure self-reported tobacco abstinence between baseline and one month postpartum, typically ten months.",125,"If you join, you would either receive standard care or up to eight home visits from a Community Health Worker. These visits will include watching a video and reviewing self-help materials.","Not stated in the trial record.",[39],"v2"]