- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02515981
New Hampshire Medicaid Wellness Incentive Program (NHWIP)
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New Hampshire
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Concord, New Hampshire, 미국, 03301
- New Hampshire Hospital
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Concord, New Hampshire, 미국, 03301
- Riverbend Community Mental Health Center
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Derry, New Hampshire, 미국, 03038
- Center for Life Management
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Dover, New Hampshire, 미국, 03820
- Community Partners
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Keene, New Hampshire, 미국, 03431
- Mondadnock Family Services
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Lebanon And Claremont, New Hampshire, 미국
- West Central Behavioral Health Care
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Littleton And Conway, New Hampshire, 미국
- Northern Human Services
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Manchester, New Hampshire, 미국, 03103
- The Mental Health Center of Greater Manchester
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Nashua, New Hampshire, 미국, 03060
- Greater Nashua Mental Health Center at Community Council
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Nashua, New Hampshire, 미국
- Harbor Homes
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Plymouth And Laconia, New Hampshire, 미국
- Genesis Behavioral Heatlh
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Portsmouth, New Hampshire, 미국, 03801
- Seacoast Mental Health Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria for smoking intervention and weight management intervention:
- Participants must be Medicaid recipients receiving mental health treatment at one of the participating study sites in New Hampshire.
- 18 years or older
Additional Inclusion Criteria for smoking intervention only:
*Smoking 5 or more cigarettes a day or a carbon monoxide level of 5 or higher at screening.
Additional Inclusion Criteria for weight management only:
*Body Mass Index of 30 or higher or 25 or higher and sedentary lifestyle.
Exclusion Criteria for both interventions:
- Diagnosis of dementia or terminal illness (expected to result in death in 1 year or less)
- Nursing home
- Inability to speak or understand English
Additional exclusion Criteria for weight management only:
- Previous participation in the In SHAPE program
- Active eating disorder diagnosis
- Pregnancy
Additional exclusion Criteria for smoking intervention only:
*Active alcohol or drug dependence with use in the past 30 days
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Incentives
Participants randomly assigned to the incentive arm, will receive cash incentives for engaging in healthy lifestyle behaviors.
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실험적: No Incentives
Participants randomly assigned to the no incentives arm, will not receive cash incentives for engaging in healthy lifestyle behaviors.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Weight
기간: Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up
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Weight obtained using a scale at each assessment.
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Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up
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Change in the 6 minute walk test
기간: Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up
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Each participant walks as many ft as possible at a brisk pace.
The amount of feet covered in 6 minutes is documented.
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Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up
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Change in Days of Abstinence-Timeline follow back interview for tobacco smokers
기간: Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
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A timeline follow back interview is completed for the smoking cessation intervention to identify days of abstinence within the assessment period as well as amount of cigarettes smoked.
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Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
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Change in Carbon Monoxide Level
기간: Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
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At each assessment and during the incentive quit cycles, carbon monoxide level is measured to confirm smoking abstinence or not.
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Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
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공동 작업자 및 조사자
수사관
- 연구 책임자: Sarah I Pratt, PhD, Dartmouth-Hitchcock Medical Center
- 수석 연구원: Kelley Capuchino, State of New Hampshire, Department of Health and Human Services
간행물 및 유용한 링크
일반 간행물
- Bianco CL, Pratt SI, Ferron JC, Brunette MF. Electronic Cigarette Use During a Randomized Trial of Interventions for Smoking Cessation Among Medicaid Beneficiaries with Mental Illness. J Dual Diagn. 2019 Jul-Sep;15(3):184-191. doi: 10.1080/15504263.2019.1620400. Epub 2019 Jun 6.
- Brunette MF, Pratt SI, Bartels SJ, Scherer EA, Sigmon SC, Ferron JC, Santos M, Williams GE, Kosydar S, Wolfe RS, Lotz D, Capuchino K. Randomized Trial of Interventions for Smoking Cessation Among Medicaid Beneficiaries With Mental Illness. Psychiatr Serv. 2018 Mar 1;69(3):274-280. doi: 10.1176/appi.ps.201700245. Epub 2017 Nov 15.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .