Tobacco Use Clinical Trial
— SFHOPEOfficial 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.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | August 2025 |
Est. primary completion date | May 2025 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University Medical Center | Loma Linda | California |
United States | Riverside University Health Systems | Moreno Valley | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University | Riverside University Health System Medical Center, University of California, San Francisco |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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+ |
Change between baseline and 1 month postpartum visit, typically ten months | |
Secondary | 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. | Baseline; during the intervention; through study completion, an average of 10 months. |
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