- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02515981
New Hampshire Medicaid Wellness Incentive Program (NHWIP)
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New Hampshire
-
Concord, New Hampshire, Förenta staterna, 03301
- New Hampshire Hospital
-
Concord, New Hampshire, Förenta staterna, 03301
- Riverbend Community Mental Health Center
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Derry, New Hampshire, Förenta staterna, 03038
- Center for Life Management
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Dover, New Hampshire, Förenta staterna, 03820
- Community Partners
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Keene, New Hampshire, Förenta staterna, 03431
- Mondadnock Family Services
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Lebanon And Claremont, New Hampshire, Förenta staterna
- West Central Behavioral Health Care
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Littleton And Conway, New Hampshire, Förenta staterna
- Northern Human Services
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Manchester, New Hampshire, Förenta staterna, 03103
- The Mental Health Center of Greater Manchester
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Nashua, New Hampshire, Förenta staterna, 03060
- Greater Nashua Mental Health Center at Community Council
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Nashua, New Hampshire, Förenta staterna
- Harbor Homes
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Plymouth And Laconia, New Hampshire, Förenta staterna
- Genesis Behavioral Heatlh
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Portsmouth, New Hampshire, Förenta staterna, 03801
- Seacoast Mental Health Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Incentives
Participants randomly assigned to the incentive arm, will receive cash incentives for engaging in healthy lifestyle behaviors.
|
|
Experimentell: No Incentives
Participants randomly assigned to the no incentives arm, will not receive cash incentives for engaging in healthy lifestyle behaviors.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in Weight
Tidsram: Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up
|
Weight obtained using a scale at each assessment.
|
Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up
|
Change in the 6 minute walk test
Tidsram: Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up
|
Each participant walks as many ft as possible at a brisk pace.
The amount of feet covered in 6 minutes is documented.
|
Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up
|
Change in Days of Abstinence-Timeline follow back interview for tobacco smokers
Tidsram: Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
|
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.
|
Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
|
Change in Carbon Monoxide Level
Tidsram: Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
|
At each assessment and during the incentive quit cycles, carbon monoxide level is measured to confirm smoking abstinence or not.
|
Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Studierektor: Sarah I Pratt, PhD, Dartmouth-Hitchcock Medical Center
- Huvudutredare: Kelley Capuchino, State of New Hampshire, Department of Health and Human Services
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 23336
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