Testing Strategies to Encourage Weight Loss in an Employer Setting

Study Overview
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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.

Official Title
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Testing Strategies to Encourage Weight Loss in an Employer Setting

Conditions
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Weight Loss

Intervention / Treatment
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* Behavioral: No intervention
* Behavioral: Group-based payout
* Behavioral: Individual payout


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Individual payout<br>* 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<br>|
| Experimental: 2<br> | Behavioral: Group-based payout<br>* 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<br>|
| Active Comparator: 3<br> | Behavioral: No intervention<br>* Monthly weigh-ins for 6 months without financial incentives associated with weight loss, and follow-up weigh-in at 9 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight between baseline and six months |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| usability of a newly developed web portal and its feasibility for future randomized clinical trials aimed at changing health-related behaviors |  | end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Weight Loss, Motivation, Workplace, Web platform