Testing Strategies to Encourage Weight Loss in an Employer Setting

Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01208350
Collaborator
Children's Hospital of Philadelphia (Other), incentaHEALTH (Industry), National Institutes of Health (NIH) (NIH), National Institute on Aging (NIA) (NIH)
105
1
3
41
2.6

Study Details

Study Description

Brief Summary

This is a 3-arm pilot randomized controlled trial to evaluate the effectiveness of two novel ways of structuring financial incentives to motivate and sustain long-term weight loss. The study will recruit eligible employees at Children's Hospital of Philadelphia (CHOP) to participate in a 6-month weight loss program and an additional 3-month follow-up period. The primary outcome measure in this randomized control trial will be pounds of weight lost between baseline and 6 months. The goal of this study is to evaluate whether a novel financial incentive program delivered through a workplace can effectively encourage sustained weight loss among obese employees.

The study hypotheses are 1) mean weight loss will be greater in all the intervention groups compared to the control group by the end of the 24-week intervention period; and 2) individuals in the intervention groups will have a lower mean weight at the end of the 12-week follow-up period than individuals in the control group.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: No intervention
  • Behavioral: Group-based payout
  • Behavioral: Individual payout
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Testing Strategies to Encourage Weight Loss in an Employer Setting
Study Start Date :
Mar 1, 2011
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Behavioral: Individual payout
Monthly weigh-ins for 6 months and if monthly goals are met, participants receive payout at the end of the month, with follow-up weigh-in at 9 months

Experimental: 2

Behavioral: Group-based payout
Monthly weigh-ins for 6 months where five sequential participants, randomized to this condition, will be joined into virtual groups where individual rewards for weight loss are dependent on the weight loss of others in the group, with follow-up weigh in at 9 months

Active Comparator: 3

Behavioral: No intervention
Monthly weigh-ins for 6 months without financial incentives associated with weight loss, and follow-up weigh-in at 9 months

Outcome Measures

Primary Outcome Measures

  1. Change in weight between baseline and six months [24 weeks]

Secondary Outcome Measures

  1. usability of a newly developed web portal and its feasibility for future randomized clinical trials aimed at changing health-related behaviors [end of study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Aged 18 to 70 (inclusive)

  • BMI between 30 and 40 (inclusive)

Exclusion Criteria:
  • Inability to consent

  • Illiteracy and/or inability to speak, read, and write English

  • Participation in another research study

  • Current treatment for drug or alcohol use

  • Consumption of ≥ 5 alcoholic drinks per day

  • Myocardial infarction or stroke within the past 6 months

  • Current addiction to prescription medicines or street drugs

  • Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia)

  • Pregnant or currently breastfeeding

  • Diabetic and using any medicine besides metformin to control blood glucose

  • Metastatic cancer

  • Unstable medical conditions that would likely prevent the subject from completing the study

  • Previous diagnosis of an eating disorder

  • History of unsafe weight loss behaviors such as binging or the use of laxatives

Contacts and Locations

Locations

Site City State Country Postal Code
1 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • Children's Hospital of Philadelphia
  • incentaHEALTH
  • National Institutes of Health (NIH)
  • National Institute on Aging (NIA)

Investigators

  • Study Chair: Kevin Volpp, MD, PhD, University of Pennsylvania
  • Principal Investigator: Jeffrey T Kullgren, MD, MPH, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01208350
Other Study ID Numbers:
  • 812193
  • RC2AG036592
First Posted:
Sep 23, 2010
Last Update Posted:
Sep 8, 2014
Last Verified:
Sep 1, 2012
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2014