Testing Strategies to Encourage Weight Loss in an Employer Setting

NCT ID: NCT01208350

Last Updated: 2014-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Individual payout

Intervention Type BEHAVIORAL

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

2

Group Type EXPERIMENTAL

Group-based payout

Intervention Type BEHAVIORAL

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

3

Group Type ACTIVE_COMPARATOR

No intervention

Intervention Type BEHAVIORAL

Monthly weigh-ins for 6 months without financial incentives associated with weight loss, and follow-up weigh-in at 9 months

Interventions

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No intervention

Monthly weigh-ins for 6 months without financial incentives associated with weight loss, and follow-up weigh-in at 9 months

Intervention Type 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

Intervention Type 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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

incentaHEALTH

INDUSTRY

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Volpp, MD, PhD

Role: STUDY_CHAIR

University of Pennsylvania

Jeffrey T Kullgren, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23546562 (View on PubMed)

Other Identifiers

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RC2AG036592

Identifier Type: NIH

Identifier Source: secondary_id

View Link

812193

Identifier Type: -

Identifier Source: org_study_id

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