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Smartphone-based Financial Incentives

2026년 5월 12일 업데이트: Allison N Kurti, University of Vermont

Cigarette smoking during pregnancy increases risk for catastrophic pregnancy complications, growth retardation, other adverse fetal and infant health problems, and later-in-life chronic conditions among exposed offspring. The most effective intervention for reducing smoking during pregnancy is financial incentives whereby participants earn incentives (e.g., gift cards, cash) contingent on objective evidence of smoking abstinence. However, financial incentives-based interventions are typically delivered in relatively intense protocols requiring frequent clinic visits, which limits the geographical range over which services can be delivered and potentially denies treatment to those residing in remote or otherwise difficult to reach settings.

The present study will examine the feasibility, efficacy, and cost-effectiveness of a smartphone-based financial incentives intervention whereby smoking monitoring and delivery of incentives are completed remotely using a mobile app (to be designed by DynamiCare Health, Inc.). Eligible participants who complete the informed consent process will be randomized to one of two conditions: an incentives condition wherein women will receive financial incentives contingent on the remote submission of breath and saliva specimens indicating abstinence from recent smoking (described below), or a best practices control condition in which women will receive usual care for smoking cessation that is provided at their obstetrical clinics, as well as three brief educational sessions and referral to the Vermont (or other state) pregnancy-specific quit line by our research staff.

For inclusion in the study, women must meet the following criteria: (a) > 18 years of age, (b) report being smokers at the time they learned of the current pregnancy, (c) report smoking in the 7 days prior to completing their phone eligibility screening, (c) < 25 weeks pregnant, (d) speak English, (e) own a smartphone (Android or iOS; 81.8% of pregnant women in wave 1 [2013-2014] of the Population Assessment of Tobacco and Health [PATH] reported owning a smartphone). Exclusion criteria include: (a) current or prior mental or medical condition that may interfere with study participation (assessed via self-report during phone eligibility screening), (b) smoke marijuana more than once each week and not willing to quit (marijuana smoking can inflate breath CO), (c) exposed to unavoidable occupational sources of CO (e.g., car mechanic), and (d) self-report currently being maintained on opioid maintenance therapy (e.g., methadone, buprenorphine).

Participants randomized to the incentives condition will select a quit date (either the first or second Monday following their enrollment), and will submit videos of themselves blowing into a breath CO monitor twice daily during week 1. They will receive incentives for every sample where expired breath CO is < 6 ppm. Beginning in week 2 and extending through week 6, participants will submit videos twice per week (Monday/Thursday) for which they will receive incentives for providing videos of themselves completing saliva cotinine tests indicating smoking abstinence. From week 7 until delivery, participants will submit videos once per week and will continue to receive incentives for saliva cotinine tests indicating no smoking. During the postpartum period, women will submit videos twice weekly for the first 4 weeks and once weekly from weeks 5-12. Women will receiving incentives for negative breath and saliva samples, and the value of incentives will increase with each consecutive sample indicating smoking abstinence. Participants will not receive incentives for missed samples or samples that indicate smoking, and the incentive schedule will be reset at its starting value. However two consecutive negative samples following a missed or positive sample will restore the incentive to its prior value.

Women in both conditions will complete seven formal assessments of their smoking status during their participation along with a treatment acceptability questionnaire and semi-structured interview on barriers and facilitators of treatment engagement.

We conducted a power analysis to estimate the number of participants required to detect treatment effects assuming late-pregnancy abstinence rates of approximately 40% vs. < 10% (incentives vs. best practices, respectively), and 24-week postpartum abstinence rates of approximately 20% vs. < 5%. The proposed sample size of 76 per treatment condition will result in at least 80% power to detect a difference between the two treatment conditions in abstinence rates of 40% vs. 10 % at late-pregnancy or 20% vs. 5% at 24-weeks postpartum assessments using a chi-square test and significance level of 0.05.

연구 개요

연구 유형

중재적

등록 (실제)

150

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • Vermont
      • Burlington, Vermont, 미국, 05401
        • University of Vermont

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

설명

Inclusion Criteria:

  • > 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

Exclusion Criteria:

  • current or prior mental or medical condition that may interfere with study participation (assessed via self-report during formal intake assessment completed online or by phone using a medical and psychosocial history questionnaire)
  • 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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Best Practices
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 three assessments that take place during pregnancy.
실험적: Best Practices + Financial Incentives

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 three assessments that take place during pregnancy.

Best Practices + Financial Incentive- Women assigned to this condition will receive the best practices treatment described above plus the remote incentives intervention.

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.

다른 이름들:
  • 비상 관리

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Early Pregnancy Quit Rate
기간: One month after participant's enrollment date
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
One month after participant's enrollment date
Late Pregnancy Quit Rate
기간: 28 weeks gestation or later
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
28 weeks gestation or later
4-week Postpartum Quit Rate
기간: 4 weeks following the date that participants deliver their infant
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
4 weeks following the date that participants deliver their infant
8-week Postpartum Quit Rate
기간: 8 weeks following the date that participants deliver their infant
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
8 weeks following the date that participants deliver their infant
12-week Postpartum Quit Rate
기간: 12 weeks following the date that participants deliver their infant
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
12 weeks following the date that participants deliver their infant
24-week Postpartum Follow-up
기간: 24 weeks following the date that participants deliver their infant
Point prevalence smoking abstinence (defined as a cotinine-negative saliva test AND self-reported no smoking in the past seven days)
24 weeks following the date that participants deliver their infant
Longest Duration of Abstinence (LDA)
기간: LDA will be measured from participant's date of enrollment in the study to 24-wks postpartum
Consecutive days of no smoking using biochemical verification (cotinine-negative saliva at the formal assessments described above) plus self-report (cigarettes per day from enrollment to 24 wks postpartum reported during timeline follow-back conducted over the phone)
LDA will be measured from participant's date of enrollment in the study to 24-wks postpartum
Mean birth weight
기간: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
Mean birth weight (in grams) as reported on delivery reports among infants born to mothers enrolled in the study
Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
Gestational age at delivery
기간: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
Gestational age (in weeks) at delivery as reported on delivery reports among infants born to mothers enrolled in the study
Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
NICU admissions
기간: Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates
Yes/no regarding whether infant was admitted to the NICU, and number of days in the NICU, as reported on delivery reports among infants born to mothers enrolled in the study
Participants sign a medical release for their infant's birth report prior to study enrollment. Fax requests for infant birth reports are submitted upon confirming actual delivery dates/locations with them or within 1 month of expected delivery dates

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2019년 4월 1일

기본 완료 (실제)

2021년 6월 16일

연구 완료 (실제)

2021년 6월 16일

연구 등록 날짜

최초 제출

2019년 4월 4일

QC 기준을 충족하는 최초 제출

2019년 4월 18일

처음 게시됨 (실제)

2019년 4월 19일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 14일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 12일

마지막으로 확인됨

2026년 5월 1일

추가 정보

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아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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