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A Test of Different Degrees of Cost Sharing on Program Uptake and Attendance

This study is not yet open for participant recruitment.
Verified December 2012 by University of Pennsylvania
Sponsor:
Collaborators:
Harvard University
Duke University
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01756066
First received: December 19, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

To test the uptake of four different cost sharing discounts for enrolling in the Weight Watchers weight loss program as well as outcomes (program attendance and weight loss) over 12 months.


Condition Intervention
Obesity
 Behavioral: Different levels of cost sharing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Test of Different Degrees of Cost Sharing on Program Uptake and Attendance

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Uptake [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    the percent of patients who sign up for the program, by arm


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Program attendance and weight loss among participants who sign up for the program


Estimated Enrollment: 800
Study Start Date: January 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Participant has 50% subsidy, i.e. gets a 50% discount off regular price of the program
 Behavioral: Different levels of cost sharing
Experimental: B
Participant has 100% subsidy, i.e. program attendance is free
 Behavioral: Different levels of cost sharing
Experimental: C
Participant has 80% subsidy; i.e. gets 80% discount off regular price of the program
 Behavioral: Different levels of cost sharing
Experimental: D
Participant has 50% subsidy up front (i.e. pays 50%), with possibility for 100% subsidy based on attaining monthly participation goals
 Behavioral: Different levels of cost sharing

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must be employee of Vanguard Health Systems over the age of 18
  2. Must have a BMI of 21 or greater

Exclusion Criteria:

  1. Must not be under the age of 18
  2. Must not have a BMI lower than 21
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756066

Contacts
Contact: Joelle Friedman, MPA joellef@mail.med.upenn.edu

Locations
United States, Tennessee
Vanguard Health Systems Not yet recruiting
Nashville, Tennessee, United States, 37215
Contact: Masser         smasser@vanguardhealth.com    
Sponsors and Collaborators
University of Pennsylvania
Harvard University
Duke University
Investigators
Principal Investigator: Kevin Volpp, MD, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01756066     History of Changes
Other Study ID Numbers: 816444
Study First Received: December 19, 2012
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Obesity
Weight loss program
incentives

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013