- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02515981
New Hampshire Medicaid Wellness Incentive Program (NHWIP)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Hampshire
-
Concord, New Hampshire, United States, 03301
- New Hampshire Hospital
-
Concord, New Hampshire, United States, 03301
- Riverbend Community Mental Health Center
-
Derry, New Hampshire, United States, 03038
- Center for Life Management
-
Dover, New Hampshire, United States, 03820
- Community Partners
-
Keene, New Hampshire, United States, 03431
- Mondadnock Family Services
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Lebanon And Claremont, New Hampshire, United States
- West Central Behavioral Health Care
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Littleton And Conway, New Hampshire, United States
- Northern Human Services
-
Manchester, New Hampshire, United States, 03103
- The Mental Health Center of Greater Manchester
-
Nashua, New Hampshire, United States, 03060
- Greater Nashua Mental Health Center at Community Council
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Nashua, New Hampshire, United States
- Harbor Homes
-
Plymouth And Laconia, New Hampshire, United States
- Genesis Behavioral Heatlh
-
Portsmouth, New Hampshire, United States, 03801
- Seacoast Mental Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Incentives
Participants randomly assigned to the incentive arm, will receive cash incentives for engaging in healthy lifestyle behaviors.
|
|
Experimental: No Incentives
Participants randomly assigned to the no incentives arm, will not receive cash incentives for engaging in healthy lifestyle behaviors.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Weight
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Sarah I Pratt, PhD, Dartmouth-Hitchcock Medical Center
- Principal Investigator: Kelley Capuchino, State of New Hampshire, Department of Health and Human Services
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23336
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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