SmokingNCT05019170
Remote Incentives for Smoking Cessation Among AN Pregnant Women
A study testing Smartphone-based Financial Incentives and Best Practices in people with Smoking and Smoking Cessation, run by University of Vermont at 2 sites in United States.
Trial summary
Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse infant health problems, and later-in-life chronic conditions. One group that is particularly at risk for these complications are Alaska Native (AN) women. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Smartphone-based Financial Incentives and Best Practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Dec 2021to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- report being smokers at the time they learned of the current pregnancy
- report smoking in the 7 days prior to completing their preliminary eligibility screening
- < 25 weeks pregnant
- speak English
- own a smartphone (Android or iOS)
- self-report as an Alaska Native
- current smoker as verified by saliva cotinine test
Who cannot join
- current or prior mental or medical condition that may interfere with study participation
- smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO)
- exposed to unavoidable occupational sources of CO (e.g., car mechanic)
- report currently receiving opioid maintenance therapy (e.g., methadone, buprenorphine)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Alaska Native Tribal Health Consortium
Anchorage, Alaska, 99508
University of Vermont
Burlington, Vermont, 05401
About this study
Official title: Smartphone-based Financial Incentives to Promote Smoking Cessation Among Alaska Native Pregnant Women
Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse infant health problems, and later-in-life chronic conditions. One group that is particularly at risk for these complications are Alaska Native (AN) women. Prevalence of smoking during pregnancy is disproportionally high among AN women compared to US pregnant women overall (i.e., ~36% and ~13%, respectively) and few smoking-cessation interventions have been evaluated among this population. A substantive barrier to offering evidence-based interventions to AN women is the geographic remoteness of Alaska. The most effective intervention for promoting smoking cessation during pregnancy is financial incentives in which participants earn incentives (e.g., cash) contingent on objective evidence of smoking abstinence. This intervention has been adapted to be delivered entirely through a smartphone meaning that the geographic remoteness of Alaska will not be a barrier with this intervention. Participants submit videos of themselves completing breath and saliva tests, and incentives are then delivered through the application if the tests indicate smoking abstinence. Through a collaboration between the University of Vermont and the Alaska Native Tribal Health Consortium, the goal of this study is to examine the preliminary feasibility and efficacy of this smartphone-based incentives intervention among AN women. Pregnant AN women will be recruited through ads posted on social media. Eligible participants who complete the informed consent process will be randomized to either: Best Practices or Best Practices + Incentives. In the Best Practices condition, participants will receive three brief educational sessions and a referral to the Alaska state quitline. In the Best Practices + Incentives condition, participants will receive the same education sessions and quitline referral, plus financial incentives contingent on the smartphone-based testing of breath and saliva specimens indicating abstinence from recent smoking. Outcomes will include point prevalence smoking abstinence at assessments conducted in late pregnancy and 4-, 8-, 12-, and 24-weeks postpartum, continuous abstinence during antepartum and postpartum, and perceived barriers and facilitators of treatment engagement. Overall, this project has the potential to address disparities in access to efficacious, evidence-based smoking cessation treatments among AN pregnant women.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Smartphone-based Financial Incentives, Best Practices
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone-based Financial IncentivesBehavioural
Also called Contingency Management
Financial Incentives - Beginning on the quit date and extending for one week, participants will be required to submit twice daily CO samples. All samples < 6 ppm will be considered negative and those > 6 ppm will be considered positive. Participants will earn incentives for breath tests indicating smoking abstinence, and incentive values will increase with each consecutive negative sample. Following the initial quit week, the schedule of monitoring will be reduced, and incentives will be contingent on submitting a negative saliva cotinine test.
Best PracticesBehavioural
Best Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at assessments that take place during pregnancy.
| Study group | Role | What they receive |
|---|---|---|
| Best Practices + Incentives group | Experimental | Participants assigned to this condition will receive the best practices treatment plus the financial incentives intervention. Receives: Behavioral: Smartphone-based Financial Incentives; Behavioral: Best Practices |
| Best Practices | Active comparator | Participants assigned to this condition will receive the best practices treatment alone. Receives: Behavioral: Best Practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late Pregnancy Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: 28 weeks gestation through date of delivery
Secondary outcomes (6)
Early Pregnancy Quit Rate
Point prevalence smoking abstinence (defined as a cotinine negative saliva test AND self-reported no smoking in the past seven days)
Measured: One month after participant's enrollment date
4-Week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: 4 weeks following the date that participants deliver their infant
8-Week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: 8 weeks following the date that participants deliver their infant
12-Week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: 12 weeks following the date that participants deliver their infant
24-Week Postpartum Quit Rate
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
Measured: 24 weeks following the date that participants deliver their infant
Longest Duration of Abstinence (LDA)
Consecutive days of no smoking using biochemical verification (cotinine-negative saliva at the formal assessments) plus self-report (cigarettes per day from enrollment to 24 weeks postpartum reported during timeline follow-back conducted over the phone)
Measured: LDA will be measured from participant's date of enrollment in the study to 24-weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start15 Dec 2021
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Why it stopped: Could not recruit enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- 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 investigators are proposing a two-condition, parallel groups, randomized controlled pilot study of a smartphone-based financial incentives intervention for AN pregnant smokers. The experimental group will receive financial incentives (money loaded onto a debit card) contingent on the remote submission of breath carbon monoxide and saliva cotinine tests indicating smoking abstinence in addition to best practices for promoting smoking cessation (Best Practices + Incentives). The control group will receive best practices alone (Best Practices). The use of a best practices group reflects a real-world comparison condition in that all women will receive the treatment that practitioners in the community are instructed to provide (the 5As + quitline referral) thereby enhancing the ecological validity of the study. Additionally, the investigators will minimize between-subject variability in the participant's exposure to these practices by implementing these treatment components themselves.
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Alaska Native Tribal Health Consortium, Mayo Clinic
- Responsible party
- Principal investigator, Diann Gaalema, University of Vermont
- Investigators
- Diann Gaalema, PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019170
- Sponsor's protocol ID
- 1558083
- Status last verified
- Nov 2023
- First submitted
- 9 Aug 2021
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurti AN, Tang K, Bolivar HA, Evemy C, Medina N, Skelly J, Nighbor T, Higgins ST. Smartphone-based financial incentives to promote smoking cessation during pregnancy: A pilot study. Prev Med. 2020 Nov;140:106201. doi: 10.1016/j.ypmed.2020.106201. Epub 2020 Jul 9.
PubMed 32652133
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-based Financial Incentives to Promote Smoking Cessation Among Alaska Native Pregnant Women
- ClinicalTrials.gov ID
- NCT05019170
- Acronym / sponsor ID
- 1558083
- Conditions
- Smoking, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Could not recruit enough patients
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Alaska Native Tribal Health Consortium, Mayo Clinic
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 24 Aug 2021 (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.
Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse infant health problems, and later-in-life chronic conditions. One group that is particularly at risk for these complications are Alaska Native (AN) women. Prevalence of smoking during pregnancy is disproportionally high among AN women compared to US pregnant women overall (i.e., ~36% and ~13%, respectively) and few smoking-cessation interventions have been evaluated among this population. A substantive barrier to offering evidence-based interventions to AN women is the geographic remoteness of Alaska. The most effective intervention for promoting smoking cessation during pregnancy is financial incentives in which participants earn incentives (e.g., cash) contingent on objective evidence of smoking abstinence. This intervention has been adapted to be delivered entirely through a smartphone meaning that the geographic remoteness of Alaska will not be a barrier with this intervention. Participants submit videos of themselves completing breath and saliva tests, and incentives are then delivered through the application if the tests indicate smoking abstinence. Through a collaboration between the University of Vermont and the Alaska Native Tribal Health Consortium, the goal of this study is to examine the preliminary feasibility and efficacy of this smartphone-based incentives intervention among AN women. Pregnant AN women will be recruited through ads posted on social media. Eligible participants who complete the informed consent process will be randomized to either: Best Practices or Best Practices + Incentives. In the Best Practices condition, participants will receive three brief educational sessions and a referral to the Alaska state quitline. In the Best Practices + Incentives condition, participants will receive the same education sessions and quitline referral, plus financial incentives contingent on the smartphone-based testing of breath and saliva specimens indicating abstinence from recent smoking. Outcomes will include point prevalence smoking abstinence at assessments conducted in late pregnancy and 4-, 8-, 12-, and 24-weeks postpartum, continuous abstinence during antepartum and postpartum, and perceived barriers and facilitators of treatment engagement. Overall, this project has the potential to address disparities in access to efficacious, evidence-based smoking cessation treatments among AN pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The investigators are proposing a two-condition, parallel groups, randomized controlled pilot study of a smartphone-based financial incentives intervention for AN pregnant smokers. The experimental group will receive financial incentives (money loaded onto a debit card) contingent on the remote submission of breath carbon monoxide and saliva cotinine tests indicating smoking abstinence in addition to best practices for promoting smoking cessation (Best Practices + Incentives). The control group will receive best practices alone (Best Practices). The use of a best practices group reflects a real-world comparison condition in that all women will receive the treatment that practitioners in the community are instructed to provide (the 5As + quitline referral) thereby enhancing the ecological validity of the study. Additionally, the investigators will minimize between-subject variability in the participant's exposure to these practices by implementing these treatment components themselves.
| Arm | Type | Receives |
|---|---|---|
| Best Practices + Incentives group | Experimental | Behavioral: Smartphone-based Financial Incentives, Behavioral: Best PracticesParticipants assigned to this condition will receive the best practices treatment plus the financial incentives intervention. |
| Best Practices | Active comparator | Behavioral: Best PracticesParticipants assigned to this condition will receive the best practices treatment alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years of age
- report being smokers at the time they learned of the current pregnancy
- report smoking in the 7 days prior to completing their preliminary eligibility screening
- < 25 weeks pregnant
- speak English
Key exclusion criteria (4 listed)
- current or prior mental or medical condition that may interfere with study participation
- smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO)
- exposed to unavoidable occupational sources of CO (e.g., car mechanic)
- report currently receiving opioid maintenance therapy (e.g., methadone, buprenorphine)
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 |
|---|---|---|
| Smartphone-based Financial IncentivesAlso: Contingency ManagementFinancial Incentives - Beginning on the quit date and extending for one week, participants will be required to submit twice daily CO samples. All samples < 6 ppm will be considered negative and those > 6 ppm will be considered positive. Participants will earn incentives for breath tests indicating smoking abstinence, and incentive values will increase with each consecutive negative sample. Following the initial quit week, the schedule of monitoring will be reduced, and incentives will be contingent on submitting a negative saliva cotinine test. | Behavioural | Best Practices + Incentives group |
| Best PracticesBest Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at assessments that take place during pregnancy. | Behavioural | Best Practices, Best Practices + Incentives group |
Primary outcome
Late Pregnancy Quit Rate
Time frame: 28 weeks gestation through date of delivery
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
6 secondary outcomes
Early Pregnancy Quit Rate
Time frame: One month after participant's enrollment date
4-Week Postpartum Quit Rate
Time frame: 4 weeks following the date that participants deliver their infant
8-Week Postpartum Quit Rate
Time frame: 8 weeks following the date that participants deliver their infant
12-Week Postpartum Quit Rate
Time frame: 12 weeks following the date that participants deliver their infant
24-Week Postpartum Quit Rate
Time frame: 24 weeks following the date that participants deliver their infant
Longest Duration of Abstinence (LDA)
Time frame: LDA will be measured from participant's date of enrollment in the study to 24-weeks postpartum
Results and safety
The study was stopped early (reason given: Could not recruit enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Background: PubMed 32652133Kurti AN, Tang K, Bolivar HA, Evemy C, Medina N, Skelly J, Nighbor T, Higgins ST. Smartphone-based financial incentives to promote smoking cessation during pregnancy: A pilot study. Prev Med. 2020 Nov;140:106201. doi: 10.1016/j.ypmed.2020.106201. Epub 2020 Jul 9.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Diann Gaalema, PhD principal investigator
University of Vermont
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone-based Financial Incentives and Best Practices in people with Smoking and Smoking Cessation, run by University of Vermont 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 1 Dec 2023. 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?
The study was stopped early (reason given: Could not recruit enough patients). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late Pregnancy Quit Rate (time frame: 28 weeks gestation through date of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05019170, which also lists 1 linked publication.
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 1 Dec 2023.