Integrating CHWs Into Prenatal Care for Maternal Smoking Cessation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorLoma Linda University
About this trial
This develops a novel behavioral tobacco cessation program for pregnant smokers in San Bernardino County.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
< 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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
HCP-CHW Integration into Prenatal Care for Smoking Cessation
BehavioralCHWs 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 Arm
Other interventionStandard of Care which provides referrals to community-based smoking cessation resources.
Treatment groups
105 Participants
are divided into 2 treatment groupsGroup A: Integrated HCP-CHW Intervention ArmExperimental treatment 1 intervention
Group B: Control armOther 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 months2
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.Sponsors and contacts
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Loma Linda University
Lead sponsor
University of California, San Francisco
Collaborator
Riverside University Health System Medical Center
Collaborator
Source ClinicalTrials.gov