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Testing Strategies to Encourage Weight Loss in an Employer Setting

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ClinicalTrials.gov Identifier: NCT01208350
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : September 8, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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

Study Design

Study Type : Interventional  (Clinical Trial)
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 : March 2011
Primary Completion Date : January 2012
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 [ Time Frame: 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 [ Time Frame: end of study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01208350     History of Changes
Other Study ID Numbers: 812193
RC2AG036592 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: September 8, 2014
Last Verified: September 2012

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

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