Clinical trial NCT02515981: New Hampshire Medicaid Wellness Incentive Program
Official title: New Hampshire Medicaid Wellness Incentive Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Obesity
Mental Illness
Keywords: tobacco dependence
smoking cessation
mental health
cardiovascular disease
obesity
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: State of New Hampshire Bureau of Behavioral Health
First posted: 2015-08-05
Enrollment: 2800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change in Weight
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up
measure: Change in the 6 minute walk test
timeFrame: Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up
measure: Change in Days of Abstinence-Timeline follow back interview for tobacco smokers
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
measure: Change in Carbon Monoxide Level
timeFrame: Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Concord
country: United States
facility: New Hampshire Hospital
state: New Hampshire
city: Concord
country: United States
facility: Riverbend Community Mental Health Center
state: New Hampshire
city: Derry
country: United States
facility: Center for Life Management
state: New Hampshire
city: Dover
country: United States
facility: Community Partners
state: New Hampshire
city: Keene
country: United States
facility: Mondadnock Family Services
state: New Hampshire
city: Lebanon And Claremont
country: United States
facility: West Central Behavioral Health Care
state: New Hampshire
city: Littleton And Conway
country: United States
facility: Northern Human Services
state: New Hampshire
city: Manchester
country: United States
facility: The Mental Health Center of Greater Manchester
state: New Hampshire
city: Nashua
country: United States
facility: Greater Nashua Mental Health Center at Community Council
state: New Hampshire
city: Nashua
country: United States
facility: Harbor Homes
state: New Hampshire
city: Plymouth And Laconia
country: United States
facility: Genesis Behavioral Heatlh
state: New Hampshire
city: Portsmouth
country: United States
facility: Seacoast Mental Health Center
state: New Hampshire
Study officials:
affiliation: Dartmouth-Hitchcock Medical Center
name: Sarah I Pratt, PhD
role: STUDY_DIRECTOR
affiliation: State of New Hampshire, Department of Health and Human Services
name: Kelley Capuchino
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.