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Helping Employees Lose Pounds (HELP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853877
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Jeffrey T. Kullgren, University of Michigan

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.


Condition or disease Intervention/treatment Phase
Weight Loss Behavioral: Weekly Incentive Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Translating Insights From Behavioral Economics and Self-Determination Theory to Promote Sustained Weight Loss Among Obese Employees
Actual Study Start Date : August 2, 2016
Actual Primary Completion Date : January 4, 2017
Actual Study Completion Date : April 7, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Weekly Incentive
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.
Behavioral: Weekly Incentive
The tailored incentives intervention aims to assess the impact of tailored messaging and financial incentives on weight loss among obese employees.

No Intervention: Weekly Weigh-In
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.



Primary Outcome Measures :
  1. Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Change in weight as measured by participant weight measurements using Withings scales [ Time Frame: 12 weeks and 24 weeks ]

Other Outcome Measures:
  1. Change in autonomous motivation as measured by the Treatment Self-Regulation Questionnaire [ Time Frame: 24 weeks ]
  2. Change in physical activity as measured by the short form of the International Physical Activity Questionnaire [ Time Frame: 12 weeks and 24 weeks ]
  3. Change in eating behaviors as measured by the Three Factor Eating Questionnaire [ Time Frame: 12 weeks and 24 weeks ]
  4. 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 ]
  5. Change in self-efficacy to lose weight as measured by the Perceived Competence Scale [ Time Frame: 12 weeks and 24 weeks ]
  6. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02853877


Locations
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United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Jeffrey T Kullgren, MD,MS,MPH University of Michigan
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Responsible Party: Jeffrey T. Kullgren, Assistant Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT02853877    
Other Study ID Numbers: HUM00107647
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms