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New Hampshire Medicaid Wellness Incentive Program (NHWIP)

Primary Purpose

Tobacco Dependence, Obesity, Mental Illness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NH Medicaid Incentives Program
Sponsored by
Dartmouth-Hitchcock Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Tobacco Dependence focused on measuring tobacco dependence, smoking cessation, mental health, cardiovascular disease, obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New Hampshire Hospital
  • Riverbend Community Mental Health Center
  • Center for Life Management
  • Community Partners
  • Mondadnock Family Services
  • West Central Behavioral Health Care
  • Northern Human Services
  • The Mental Health Center of Greater Manchester
  • Greater Nashua Mental Health Center at Community Council
  • Harbor Homes
  • Genesis Behavioral Heatlh
  • Seacoast Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Incentives

No Incentives

Arm Description

Participants randomly assigned to the incentive arm, will receive cash incentives for engaging in healthy lifestyle behaviors.

Participants randomly assigned to the no incentives arm, will not receive cash incentives for engaging in healthy lifestyle behaviors.

Outcomes

Primary Outcome Measures

Change in Weight
Weight obtained using a scale at each assessment.
Change in the 6 minute walk test
Each participant walks as many ft as possible at a brisk pace. The amount of feet covered in 6 minutes is documented.
Change in Days of Abstinence-Timeline follow back interview for tobacco smokers
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.
Change in Carbon Monoxide Level
At each assessment and during the incentive quit cycles, carbon monoxide level is measured to confirm smoking abstinence or not.

Secondary Outcome Measures

Full Information

First Posted
January 30, 2015
Last Updated
February 18, 2019
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
State of New Hampshire Bureau of Behavioral Health
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1. Study Identification

Unique Protocol Identification Number
NCT02515981
Brief Title
New Hampshire Medicaid Wellness Incentive Program
Acronym
NHWIP
Official Title
New Hampshire Medicaid Wellness Incentive Program
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
State of New Hampshire Bureau of Behavioral Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Dependence, Obesity, Mental Illness
Keywords
tobacco dependence, smoking cessation, mental health, cardiovascular disease, obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Incentives
Arm Type
Experimental
Arm Description
Participants randomly assigned to the incentive arm, will receive cash incentives for engaging in healthy lifestyle behaviors.
Arm Title
No Incentives
Arm Type
Experimental
Arm Description
Participants randomly assigned to the no incentives arm, will not receive cash incentives for engaging in healthy lifestyle behaviors.
Intervention Type
Behavioral
Intervention Name(s)
NH Medicaid Incentives Program
Primary Outcome Measure Information:
Title
Change in Weight
Description
Weight obtained using a scale at each assessment.
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up
Title
Change in the 6 minute walk test
Description
Each participant walks as many ft as possible at a brisk pace. The amount of feet covered in 6 minutes is documented.
Time Frame
Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up
Title
Change in Days of Abstinence-Timeline follow back interview for tobacco smokers
Description
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.
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
Title
Change in Carbon Monoxide Level
Description
At each assessment and during the incentive quit cycles, carbon monoxide level is measured to confirm smoking abstinence or not.
Time Frame
Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah I Pratt, PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kelley Capuchino
Organizational Affiliation
State of New Hampshire, Department of Health and Human Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Hampshire Hospital
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Riverbend Community Mental Health Center
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Center for Life Management
City
Derry
State/Province
New Hampshire
ZIP/Postal Code
03038
Country
United States
Facility Name
Community Partners
City
Dover
State/Province
New Hampshire
ZIP/Postal Code
03820
Country
United States
Facility Name
Mondadnock Family Services
City
Keene
State/Province
New Hampshire
ZIP/Postal Code
03431
Country
United States
Facility Name
West Central Behavioral Health Care
City
Lebanon And Claremont
State/Province
New Hampshire
Country
United States
Facility Name
Northern Human Services
City
Littleton And Conway
State/Province
New Hampshire
Country
United States
Facility Name
The Mental Health Center of Greater Manchester
City
Manchester
State/Province
New Hampshire
ZIP/Postal Code
03103
Country
United States
Facility Name
Greater Nashua Mental Health Center at Community Council
City
Nashua
State/Province
New Hampshire
ZIP/Postal Code
03060
Country
United States
Facility Name
Harbor Homes
City
Nashua
State/Province
New Hampshire
Country
United States
Facility Name
Genesis Behavioral Heatlh
City
Plymouth And Laconia
State/Province
New Hampshire
Country
United States
Facility Name
Seacoast Mental Health Center
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31169077
Citation
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.
Results Reference
derived
PubMed Identifier
29137560
Citation
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.
Results Reference
derived

Learn more about this trial

New Hampshire Medicaid Wellness Incentive Program

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