Smartphone-based Incentives Intervention to Increase Smoking Cessation During Pregnancy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorUniversity of Vermont
About this trial
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the U.S. and a problem for which more effective and easy-to-access treatments are much needed. This study examines whether outcomes achieved with recommended clinical practices (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) can be improved by also offering financial incentives delivered through a smartphone for maternal smoking abstinence.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 yrs of age
Reports current pregnancy of </= 25 weeks gestational age
Consents to allow us to confirm pregnancy with healthcare provider
Reports current smoking when learned of current pregnancy
Disqualifiers
Reports current or prior mental or medical condition that may interfere with study participation
Reports current opioid agonist treatment for opioid use disorder
Current use of prescribed opioid, antipsychotic, or stimulant medications
Live with someone who is enrolled in the study
Trial design
Design model
Parallel
Treatments tested in this trial
Best Practices
BehavioralParticipants receive the 5As including a staff referral to the state tobacco quitline.
Financial Incentives
BehavioralParticipants receive financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Treatment groups
137 Participants
are divided into 2 treatment groupsGroup A: Best PracticesExperimental treatment 1 intervention
Group B: Best Practices plus Financial IncentivesExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Antepartum smoking abstinence
The primary outcome is whether women randomly assigned to the two treatment groups differ in the percentage who abstain from smoking across an early (\< 25 weeks gestation) and late (\> 25 weeks gestation) antepartum assessments defined by the percentage of participants assigned to each condition who report no smoking in the past 7 days and submit of a salivary cotinine sample that tests negative for recent smoking.
Time frame
Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration.Secondary outcomes
1
Postpartum smoking abstinence
Smoking abstinence at 2, 6, and 12 weeks postpartum defined as the percent of participants randomly assigned to each of the two treatment conditions who report no smoking in the past 7 days and submit of a salivary cotinine test sample that is negative for recent smoking.
Time frame
2-weeks, 6-weeks, 12-weeks following delivery.Other outcomes
1
Birth Outcomes
Birth outcomes calculated from data extracted from the birth delivery reports include mean birth weight, % low birth weight deliveries (\< 2500 g), mean gestational age at delivery, % premature deliveries (\< 37 weeks), incidence of Neonatal Intensive Care Unit (NICU) admissions, and mean length of stay per NICU admission.
Time frame
Birth record at time of delivery2
Treatment Acceptability Questionnaire
Participants in both treatment conditions will complete the Treatment Acceptance Questionnaire (TAQ) at the 24-weeks postpartum assessment. The TAQ will query participants about the (1) ease of use of their assigned intervention; (2) helpfulness, and (3) convenience of the intervention; (4) whether the intervention facilitated engagement with smoking-cessation treatment; (5) whether the intervention was fair, (6) fun, (7) or helpful in abstaining from smoking during pregnancy, (8) after the baby was born, and (9) longer-term; and (10) whether they would recommend the treatment that they received to others. All responses will be made using a 100-point visual analogue scale with higher scores represent greater acceptance.
Time frame
24 weeks following delivery3
Smoking abstinence at 24-weeks postpartum
Participants report no smoking in the past 7 days that is confirmed with a negative salivary cotinine test
Time frame
24 weeks after delivery4
Cost effectiveness
A cost-effectiveness analysis of adding financial incentives to the Best-Practices intervention will be conducted.
Time frame
24-weeks postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Vermont
Lead sponsor
DynamiCare Health
Collaborator
National Institute on Drug Abuse (NIDA)
Collaborator
Source ClinicalTrials.gov
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