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UPHS Weight Loss Study

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Financial incentive
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults age 18-70
  • BMI of 30 or above

Exclusion Criteria:

  • Inability to consent
  • Illiteracy and/or inability to speak, read, and write English
  • Participation in another research study

Conditions that would make participation unsafe:

  • Current treatment for drug or alcohol use
  • Consumption of at least 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

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Experimental

Arm Label

Control Arm

Delayed gratification

Immediate gratification

Financial incentive with frequent feedback

Arm Description

No other financial incentive other than for enrollment, 6-month weigh in, and completion.

In addition to the standard enrollment, 6-month, and completion incentives, if the subject loses 5% of their initial weight by the end of the study, they will receive an annual discount (distributed across bi-weekly pay periods) for 12 months beginning after the 12-month study ends. Their premium will return to normal price after this 12-month discount ends.

In addition to the standard enrollment, 6-month, and completion incentives, the subject will be told that they can weigh in again any time before the study ends when they think they have lost 5% of their initial body weight. If they did meet their 5% goal, they will begin receiving a bi-weekly premium discount during the next pay period for a total duration of 12 months. Subjects that do not meet the 5% cut off during a weigh in are allowed to re-weigh themselves as many times as they like although they are encouraged to do so when they think they have met their target weight. Their premium goes back to normal price after this 12-month discount ends.

In addition to the standard enrollment, 6-month, and completion incentives, the subject will be asked to weigh in on the IncentaHEALTH scales everyday they are at work. These subjects will participate in a daily lottery with the possibility of winning the same amount as the discount in Arms 2 and 3 over the course of the study. The subject can choose to select or be designated a two digit number that ranges from 00 to 99. Each day a lottery will be held and the subject will be given a 1% chance of matching both digits or an 18% chance of matching one digit. In order to get the lottery winnings, the subject must meet a weight goal that consistently decreases to accumulate to a 5% weight loss by the 6 month mark. After 6 months, the subject will receive the lottery winnings if they maintain that target weight (initial weight minus 5%) until the end of the 12-month study.

Outcomes

Primary Outcome Measures

Total pounds of weight lost

Secondary Outcome Measures

Weight loss of 5% of initial weight

Full Information

First Posted
February 15, 2013
Last Updated
May 4, 2015
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01800591
Brief Title
UPHS Weight Loss Study
Official Title
UPHS Weight Loss Study: Evaluating Methods to Use Health Benefits Design to Encourage Employee Weight Loss
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to compare a novel approach using financial incentives to changes in health benefit design and their impact on employee weight loss.
Detailed Description
Employers are increasingly looking for opportunities to encourage weight loss among employees. While studies have shown that financial incentives can effectively encourage weight loss, little is known about their use in health benefits design. The goal of this study is to determine whether a financial incentive program delivered to obese University of Pennsylvania Health System employees can effectively encourage weight loss when compared to changes in health benefit design. This is a randomized controlled trial involving financial incentives with four study arms: control, delayed gratification, immediate gratification, and financial incentive with frequent feedback. Participation in this study will last about 12 months. The primary goal of the study is to test the effects of a novel financial incentive program using a lottery with frequent feedback to normal benefit design structures.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Arm
Arm Type
No Intervention
Arm Description
No other financial incentive other than for enrollment, 6-month weigh in, and completion.
Arm Title
Delayed gratification
Arm Type
Experimental
Arm Description
In addition to the standard enrollment, 6-month, and completion incentives, if the subject loses 5% of their initial weight by the end of the study, they will receive an annual discount (distributed across bi-weekly pay periods) for 12 months beginning after the 12-month study ends. Their premium will return to normal price after this 12-month discount ends.
Arm Title
Immediate gratification
Arm Type
Experimental
Arm Description
In addition to the standard enrollment, 6-month, and completion incentives, the subject will be told that they can weigh in again any time before the study ends when they think they have lost 5% of their initial body weight. If they did meet their 5% goal, they will begin receiving a bi-weekly premium discount during the next pay period for a total duration of 12 months. Subjects that do not meet the 5% cut off during a weigh in are allowed to re-weigh themselves as many times as they like although they are encouraged to do so when they think they have met their target weight. Their premium goes back to normal price after this 12-month discount ends.
Arm Title
Financial incentive with frequent feedback
Arm Type
Experimental
Arm Description
In addition to the standard enrollment, 6-month, and completion incentives, the subject will be asked to weigh in on the IncentaHEALTH scales everyday they are at work. These subjects will participate in a daily lottery with the possibility of winning the same amount as the discount in Arms 2 and 3 over the course of the study. The subject can choose to select or be designated a two digit number that ranges from 00 to 99. Each day a lottery will be held and the subject will be given a 1% chance of matching both digits or an 18% chance of matching one digit. In order to get the lottery winnings, the subject must meet a weight goal that consistently decreases to accumulate to a 5% weight loss by the 6 month mark. After 6 months, the subject will receive the lottery winnings if they maintain that target weight (initial weight minus 5%) until the end of the 12-month study.
Intervention Type
Behavioral
Intervention Name(s)
Financial incentive
Primary Outcome Measure Information:
Title
Total pounds of weight lost
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Weight loss of 5% of initial weight
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Improvements in eating and physical activity habits
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults age 18-70 BMI of 30 or above Exclusion Criteria: Inability to consent Illiteracy and/or inability to speak, read, and write English Participation in another research study Conditions that would make participation unsafe: Current treatment for drug or alcohol use Consumption of at least 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
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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UPHS Weight Loss Study

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