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New Hampshire Medicaid Wellness Incentive Program (NHWIP)

18. februar 2019 opdateret af: Sarah Pratt, Dartmouth-Hitchcock Medical Center
The New Hampshire Medicaid Wellness Incentive Program (WIP) will address both the health disparity and increased costs by providing incentivized health promotion programs to overweight or obese and/or tobacco-smoking Medicaid beneficiaries receiving services at New Hampshire's 10 regional Community Mental Health Centers (CMHCs).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In the New Hampshire Medicaid Wellness Incentive Program, multiple program options will fall into two categories: (1) Supported Fitness and Weight Management and (2) Supported Smoking Cessation. Eligible participants are able to participate in 1 or both of the programs. The program options for Supported Fitness and Weight Management are: 1. Fitness Club Membership for 12 months, 2. Fitness Club Membership plus weekly meetings with a Health Mentor for 12 months (In SHAPE), 3. Weight Watchers Membership for 12 months, 4. In SHAPE plus Weight Watchers for 12 months. The options for Supported Smoking Cessation are: 1. Prescriber meeting to discuss smoking cessation treatment options, 2. Prescriber meeting plus NH State Tobacco Helpline, 3. Prescriber meeting plus Telephone-based Cognitive Behavioral Therapy for Smoking Cessation. Vouchers for memberships to community fitness centers and formal weight loss programs will be provided, as well as incentives for participation and positive outcomes. An equipoise stratified randomization design will be used to preserve the research benefits of randomization while maintaining the highly valued opportunity for consumer choice. Research assessments will be conducted at baseline, 3 months, 6 months, 9 months, and 12 months.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

2800

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • New Hampshire
      • Concord, New Hampshire, Forenede Stater, 03301
        • New Hampshire Hospital
      • Concord, New Hampshire, Forenede Stater, 03301
        • Riverbend Community Mental Health Center
      • Derry, New Hampshire, Forenede Stater, 03038
        • Center for Life Management
      • Dover, New Hampshire, Forenede Stater, 03820
        • Community Partners
      • Keene, New Hampshire, Forenede Stater, 03431
        • Mondadnock Family Services
      • Lebanon And Claremont, New Hampshire, Forenede Stater
        • West Central Behavioral Health Care
      • Littleton And Conway, New Hampshire, Forenede Stater
        • Northern Human Services
      • Manchester, New Hampshire, Forenede Stater, 03103
        • The Mental Health Center of Greater Manchester
      • Nashua, New Hampshire, Forenede Stater, 03060
        • Greater Nashua Mental Health Center at Community Council
      • Nashua, New Hampshire, Forenede Stater
        • Harbor Homes
      • Plymouth And Laconia, New Hampshire, Forenede Stater
        • Genesis Behavioral Heatlh
      • Portsmouth, New Hampshire, Forenede Stater, 03801
        • Seacoast Mental Health Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Incentives
Participants randomly assigned to the incentive arm, will receive cash incentives for engaging in healthy lifestyle behaviors.
Adfærdsmæssigt: NH Medicaid Incentives Program
Eksperimentel: No Incentives
Participants randomly assigned to the no incentives arm, will not receive cash incentives for engaging in healthy lifestyle behaviors.
Adfærdsmæssigt: NH Medicaid Incentives Program

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Weight
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Dartmouth-Hitchcock Medical Center

Samarbejdspartnere

State of New Hampshire Bureau of Behavioral Health

Efterforskere

  • Studieleder: Sarah I Pratt, PhD, Dartmouth-Hitchcock Medical Center
  • Ledende efterforsker: Kelley Capuchino, State of New Hampshire, Department of Health and Human Services

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. maj 2012

Primær færdiggørelse (Faktiske)

1. april 2016

Studieafslutning (Faktiske)

1. december 2018

Datoer for studieregistrering

Først indsendt

30. januar 2015

Først indsendt, der opfyldte QC-kriterier

4. august 2015

Først opslået (Skøn)

5. august 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 23336

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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