Tobacco DependenceNHWIPNCT02515981
New Hampshire Medicaid Wellness Incentive Program
A study testing NH Medicaid Incentives Program in people with Tobacco Dependence and Obesity, run by Dartmouth-Hitchcock Medical Center at 12 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Dependence, Obesity, Mental Illness
- What is being tested?
- NH Medicaid Incentives Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,800 participants
- Where
- 12 sitesUnited States
- Study dates
- May 2012to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy
- Additional exclusion Criteria for smoking intervention only:
- Active alcohol or drug dependence with use in the past 30 days
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
New Hampshire Hospital
Concord, New Hampshire, 03301
Riverbend Community Mental Health Center
Concord, New Hampshire, 03301
Center for Life Management
Derry, New Hampshire, 03038
Community Partners
Dover, New Hampshire, 03820
Mondadnock Family Services
Keene, New Hampshire, 03431
West Central Behavioral Health Care
Lebanon and Claremont, New Hampshire
Northern Human Services
Littleton and Conway, New Hampshire
The Mental Health Center of Greater Manchester
Manchester, New Hampshire, 03103
Greater Nashua Mental Health Center at Community Council
Nashua, New Hampshire, 03060
Harbor Homes
Nashua, New Hampshire
Genesis Behavioral Heatlh
Plymouth and Laconia, New Hampshire
Seacoast Mental Health Center
Portsmouth, New Hampshire, 03801
About this study
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).
Read the 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.
- Conditions
- Tobacco Dependence, Obesity, Mental Illness
- Being tested
- NH Medicaid Incentives Program
- Keywords
- tobacco dependence, smoking cessation, mental health, cardiovascular disease, obesity
- Medical subject headings
- Tobacco Use Disorder, Obesity, Mental Disorders, Smoking Cessation, Psychological Well-Being, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NH Medicaid Incentives ProgramBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Incentives | Experimental | Participants randomly assigned to the incentive arm, will receive cash incentives for engaging in healthy lifestyle behaviors. Receives: Behavioral: NH Medicaid Incentives Program |
| No Incentives | Experimental | Participants randomly assigned to the no incentives arm, will not receive cash incentives for engaging in healthy lifestyle behaviors. Receives: Behavioral: NH Medicaid Incentives Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weight
Weight obtained using a scale at each assessment.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up
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.
Measured: 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
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
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.
Measured: Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startMay 2012
- Primary completionApr 2016
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 2,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- State of New Hampshire Bureau of Behavioral Health
- Responsible party
- Principal investigator, Sarah Pratt, Dartmouth-Hitchcock Medical Center
- Investigators
- Sarah I Pratt, PhD, Study director, Dartmouth-Hitchcock Medical CenterKelley Capuchino, Principal investigator, State of New Hampshire, Department of Health and Human Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02515981
- Sponsor's protocol ID
- 23336
- Acronym
- NHWIP
- Status last verified
- Feb 2019
- First submitted
- 30 Jan 2015
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pratt SI, Ferron JC, Wolfe R, Xie H, Brunette M, Santos M, Williams G, Bartels S, Jue K, Capuchino K. Healthy choices, healthy changes: A randomized trial of incentives to promote healthy eating and exercise in people with schizophrenia and other serious mental illnesses. Schizophr Res. 2023 May;255:1-8. doi: 10.1016/j.schres.2023.03.007. Epub 2023 Mar 16.
PubMed 36933290Bianco 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.
PubMed 31169077Brunette 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.
PubMed 29137560
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Hampshire Medicaid Wellness Incentive Program
- ClinicalTrials.gov ID
- NCT02515981
- Acronym / sponsor ID
- NHWIP / 23336
- Conditions
- Tobacco Dependence, Obesity, Mental Illness
- Keywords
- tobacco dependence, smoking cessation, mental health, cardiovascular disease, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,800 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- State of New Hampshire Bureau of Behavioral Health
- Study start
- May 2012
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Incentives | Experimental | Behavioral: NH Medicaid Incentives ProgramParticipants randomly assigned to the incentive arm, will receive cash incentives for engaging in healthy lifestyle behaviors. |
| No Incentives | Experimental | Behavioral: NH Medicaid Incentives ProgramParticipants randomly assigned to the no incentives arm, will not receive cash incentives for engaging in healthy lifestyle behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Diagnosis of dementia or terminal illness (expected to result in death in 1 year or less)
- Nursing home
- Inability to speak or understand English
- Previous participation in the In SHAPE program
- Active eating disorder diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NH Medicaid Incentives Program | Behavioural | Incentives, No Incentives |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Derived from this study: PubMed 36933290Pratt SI, Ferron JC, Wolfe R, Xie H, Brunette M, Santos M, Williams G, Bartels S, Jue K, Capuchino K. Healthy choices, healthy changes: A randomized trial of incentives to promote healthy eating and exercise in people with schizophrenia and other serious mental illnesses. Schizophr Res. 2023 May;255:1-8. doi: 10.1016/j.schres.2023.03.007. Epub 2023 Mar 16.
- Derived from this study: PubMed 31169077Bianco 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.
- Derived from this study: PubMed 29137560Brunette 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.
Related trials for Tobacco Dependence
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Recruiting
Use of Nicotine Pouches Among Daily Smokers
Tobacco Dependence
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
Not yet recruiting
Quit With Sense: Using Mindful Smoking and Wearable Device for Smoking Cessation
Smoking Cessation, Cigarette Smoking
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah I Pratt, PhD study director
Dartmouth-Hitchcock Medical Center
Kelley Capuchino principal investigator
State of New Hampshire, Department of Health and Human Services
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NH Medicaid Incentives Program in people with Tobacco Dependence and Obesity, run by Dartmouth-Hitchcock Medical Center at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weight (time frame: Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02515981, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.