NCT01756066

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,239

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

December 21, 2015

Status Verified

December 1, 2015

Enrollment Period

1.5 years

First QC Date

December 19, 2012

Last Update Submit

December 18, 2015

Conditions

Keywords

ObesityWeight loss programincentives

Outcome Measures

Primary Outcomes (1)

  • Uptake

    the percent of patients who sign up for the program, by arm

    12 months

Secondary Outcomes (1)

  • Efficacy

    12 months

Study Arms (4)

A

ACTIVE COMPARATOR

Participant has 50% subsidy, i.e. gets a 50% discount off regular price of the program

Behavioral: Different levels of cost sharing

B

EXPERIMENTAL

Participant has 100% subsidy, i.e. program attendance is free

Behavioral: Different levels of cost sharing

C

EXPERIMENTAL

Participant has 80% subsidy; i.e. gets 80% discount off regular price of the program

Behavioral: Different levels of cost sharing

D

EXPERIMENTAL

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

Interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Must not be under the age of 18
  • Must not have a BMI lower than 21

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ingersoll Rand

Davidson, North Carolina, 28036, United States

Location

Vanguard Health Systems

Nashville, Tennessee, 37215, United States

Location

Related Publications (1)

  • John LK, Troxel AB, Yancy WS Jr, Friedman J, Zhu J, Yang L, Galvin R, Miller-Kovach K, Halpern SD, Loewenstein G, Volpp K. The Effect of Cost Sharing on an Employee Weight Loss Program: A Randomized Trial. Am J Health Promot. 2018 Jan;32(1):170-176. doi: 10.1177/0890117116671282. Epub 2016 Oct 21.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kevin Volpp, MD, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2012

First Posted

December 24, 2012

Study Start

January 1, 2013

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

December 21, 2015

Record last verified: 2015-12

Locations