Testing Strategies to Encourage Weight Loss in an Employer Setting

September 4, 2014 updated by: University of Pennsylvania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in weight between baseline and six months
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
end of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

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

Investigators

  • Study Chair: Kevin Volpp, MD, PhD, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

January 1, 2012

Study Completion (ACTUAL)

August 1, 2014

Study Registration Dates

First Submitted

September 22, 2010

First Submitted That Met QC Criteria

September 22, 2010

First Posted (ESTIMATE)

September 23, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 8, 2014

Last Update Submitted That Met QC Criteria

September 4, 2014

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 812193
  • RC2AG036592 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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