Testing Strategies to Encourage Weight Loss in an Employer Setting
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
No intervention
Group-based payout
Individual payout
Sponsored by
About this trial
This is an interventional treatment trial for Weight Loss focused on measuring Weight Loss, Motivation, Workplace, Web platform
Eligibility 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
Sites / Locations
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
Outcomes
Primary Outcome Measures
Change in weight between baseline and six months
Secondary Outcome Measures
usability of a newly developed web portal and its feasibility for future randomized clinical trials aimed at changing health-related behaviors
Full Information
NCT ID
NCT01208350
First Posted
September 22, 2010
Last Updated
September 4, 2014
Sponsor
University of Pennsylvania
Collaborators
Children's Hospital of Philadelphia, incentaHEALTH, National Institutes of Health (NIH), National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT01208350
Brief Title
Testing Strategies to Encourage Weight Loss in an Employer Setting
Official Title
Testing Strategies to Encourage Weight Loss in an Employer Setting
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Children's Hospital of Philadelphia, incentaHEALTH, National Institutes of Health (NIH), National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
Keywords
Weight Loss, Motivation, Workplace, Web platform
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
No intervention
Intervention Description
Monthly weigh-ins for 6 months without financial incentives associated with weight loss, and follow-up weigh-in at 9 months
Intervention Type
Behavioral
Intervention Name(s)
Group-based payout
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Individual payout
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in weight between baseline and six months
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Volpp, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jeffrey T Kullgren, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23546562
Citation
Kullgren JT, Troxel AB, Loewenstein G, Asch DA, Norton LA, Wesby L, Tao Y, Zhu J, Volpp KG. Individual- versus group-based financial incentives for weight loss: a randomized, controlled trial. Ann Intern Med. 2013 Apr 2;158(7):505-14. doi: 10.7326/0003-4819-158-7-201304020-00002.
Results Reference
derived
Learn more about this trial
Testing Strategies to Encourage Weight Loss in an Employer Setting
We'll reach out to this number within 24 hrs