Testing Strategies to Encourage Weight Loss in an Employer Setting

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
IncentaHEALTH
Information provided by (Responsible Party):
Kevin Volpp, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01208350
First received: September 22, 2010
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

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 Intervention
Weight Loss
Behavioral: No intervention
Behavioral: Group-based payout
Behavioral: Individual payout

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Testing Strategies to Encourage Weight Loss in an Employer Setting

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Change in weight between baseline and six months [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • usability of a newly developed web portal and its feasibility for future randomized clinical trials aimed at changing health-related behaviors [ Time Frame: end of study ] [ Designated as safety issue: No ]

Enrollment: 105
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01208350

Locations
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Children's Hospital of Philadelphia
IncentaHEALTH
Investigators
Study Chair: Kevin Volpp, MD, PhD University of Pennsylvania
Principal Investigator: Jeffrey T Kullgren, MD, MPH University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kevin Volpp, MD, MPH, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01208350     History of Changes
Other Study ID Numbers: 812193, RC2AG036592
Study First Received: September 22, 2010
Last Updated: September 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Weight Loss
Motivation
Workplace
Web platform

Additional relevant MeSH terms:
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014