Back to resultsHelping Employees Lose Pounds (HELP)
Primary Purpose
Weight Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekly Incentive
Sponsored by
About this trial
This is an interventional prevention trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- Interested in losing weight
- Body Mass Index between 30 and 40 kg/m2
- Have wireless internet at home
- Have Android or iOS smart device
- Willing to record themselves weighing in on a scale or let a family member record them weighing in on a scale
Exclusion Criteria:
- Pregnant or lactating, or intending to become pregnant in the next 6 months
- Taking medication (other than metformin) for diabetes to control blood sugar
- Having a serious psychiatric diagnosis, unstable medical conditions or experienced a heart attack or stroke in the past 6 months
- Having a history of drug or alcohol abuse or addiction to prescription medications
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Weekly Incentive
Weekly Weigh-In
Arm Description
Participants in the Weekly Incentive arm will be asked to weigh in each week during a 12 week intervention period. They will receive tailored messages and have an opportunity to win a financial reward each week they meet their weight loss goal. Participants will be asked to complete a final weight measurement at week 24.
Participants in the Weekly Weigh-In arm will be asked to weigh in each week during a 12 week intervention period. Participants will be asked to complete a final weight measurement at week 24.
Outcomes
Primary Outcome Measures
Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire
Secondary Outcome Measures
Change in weight as measured by participant weight measurements using Withings scales
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02853877
Brief Title
Helping Employees Lose Pounds
Acronym
HELP
Official Title
Translating Insights From Behavioral Economics and Self-Determination Theory to Promote Sustained Weight Loss Among Obese Employees
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2, 2016 (Actual)
Primary Completion Date
January 4, 2017 (Actual)
Study Completion Date
April 7, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will evaluate the effectiveness of financial incentives and messaging tailored to individual goals and aspirations to promote and sustain weight loss. This is a 2-arm randomized controlled trial that will recruit eligible employees at a large university to participate in a 3-month weight loss program, followed by a 3-month follow-up period. The primary outcome will be change in autonomous motivation for weight loss.
The study hypothesis is that intervention group participants will have a greater increase in autonomous motivation for weight loss than participants in the control group at 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Weekly Incentive
Arm Type
Experimental
Arm Description
Participants in the Weekly Incentive arm will be asked to weigh in each week during a 12 week intervention period. They will receive tailored messages and have an opportunity to win a financial reward each week they meet their weight loss goal. Participants will be asked to complete a final weight measurement at week 24.
Arm Title
Weekly Weigh-In
Arm Type
No Intervention
Arm Description
Participants in the Weekly Weigh-In arm will be asked to weigh in each week during a 12 week intervention period. Participants will be asked to complete a final weight measurement at week 24.
Intervention Type
Behavioral
Intervention Name(s)
Weekly Incentive
Intervention Description
The tailored incentives intervention aims to assess the impact of tailored messaging and financial incentives on weight loss among obese employees.
Primary Outcome Measure Information:
Title
Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in weight as measured by participant weight measurements using Withings scales
Time Frame
12 weeks and 24 weeks
Other Pre-specified Outcome Measures:
Title
Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire
Time Frame
24 weeks
Title
Change in physical activity as measured by the short form of the International Physical Activity Questionnaire
Time Frame
12 weeks and 24 weeks
Title
Change in eating behaviors as measured by the Three Factor Eating Questionnaire
Time Frame
12 weeks and 24 weeks
Title
Change in participation in weight-related wellness programs as measured by responses to the question "In the past 3 months, have you participated in any health and wellness programs?"
Time Frame
12 weeks and 24 weeks
Title
Change in self-efficacy to lose weight as measured by the Perceived Competence Scale
Time Frame
12 weeks and 24 weeks
Title
Change in stage of change for weight loss as measured by responses to the questions "Are you currently trying to lose weight?" and "Do you intend to try to lose weight in the near future?"
Time Frame
12 and 24 weeks
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:
Interested in losing weight
Body Mass Index between 30 and 40 kg/m2
Have wireless internet at home
Have Android or iOS smart device
Willing to record themselves weighing in on a scale or let a family member record them weighing in on a scale
Exclusion Criteria:
Pregnant or lactating, or intending to become pregnant in the next 6 months
Taking medication (other than metformin) for diabetes to control blood sugar
Having a serious psychiatric diagnosis, unstable medical conditions or experienced a heart attack or stroke in the past 6 months
Having a history of drug or alcohol abuse or addiction to prescription medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey T Kullgren, MD,MS,MPH
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Helping Employees Lose Pounds
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