New Hampshire Medicaid Wellness Incentive Program

Obesity Clinical Trial

— NHWIP  

Official title:

New Hampshire Medicaid Wellness Incentive Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515981
• Other study ID #: 23336
• Status: Completed
• Phase: N/A
• Start date: May 2012
• Est. completion date: December 2018

Study information

• Verified date: February 2019
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 Centers (CMHCs).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2800
• Est. completion date: December 2018
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Mental Illness
• Obesity
• Tobacco Dependence
• Tobacco Use Disorder

Intervention

Behavioral:
• NH Medicaid Incentives Program

Locations

Country	Name	City	State
United States	New Hampshire Hospital	Concord	New Hampshire
United States	Riverbend Community Mental Health Center	Concord	New Hampshire
United States	Center for Life Management	Derry	New Hampshire
United States	Community Partners	Dover	New Hampshire
United States	Mondadnock Family Services	Keene	New Hampshire
United States	West Central Behavioral Health Care	Lebanon And Claremont	New Hampshire
United States	Northern Human Services	Littleton And Conway	New Hampshire
United States	The Mental Health Center of Greater Manchester	Manchester	New Hampshire
United States	Greater Nashua Mental Health Center at Community Council	Nashua	New Hampshire
United States	Harbor Homes	Nashua	New Hampshire
United States	Genesis Behavioral Heatlh	Plymouth And Laconia	New Hampshire
United States	Seacoast Mental Health Center	Portsmouth	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	State of New Hampshire Bureau of Behavioral Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight	Weight obtained using a scale at each assessment.	Baseline, 3 months, 6 months, 9 months, 12 months and 1 year post program follow up
Primary	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.	Baseline, 3 months, 6 monhts, 9 months, 12 months, and 1 year post program completion follow up
Primary	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.	Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up
Primary	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.	Baseline, 3 months, 6 months, 9 months, 12 months, and 1 year post program completion follow up