UPHS Weight Loss Study
2015年5月4日 更新者：University of Pennsylvania
UPHS Weight Loss Study: Evaluating Methods to Use Health Benefits Design to Encourage Employee Weight Loss
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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
201
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：Control Arm
No other financial incentive other than for enrollment, 6-month weigh in, and completion.
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実験的：Delayed gratification
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.
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実験的：Immediate gratification
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.
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実験的：Financial incentive with frequent feedback
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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Total pounds of weight lost
時間枠：12 months
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12 months
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二次結果の測定
結果測定 |
時間枠 |
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Weight loss of 5% of initial weight
時間枠：12 months
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12 months
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その他の成果指標
結果測定 |
時間枠 |
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Improvements in eating and physical activity habits
時間枠：12 months
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12 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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- Cai L, Lubitz J, Flegal KM, Pamuk ER. The predicted effects of chronic obesity in middle age on medicare costs and mortality. Med Care. 2010 Jun;48(6):510-7. doi: 10.1097/MLR.0b013e3181dbdb20.
- Stewart ST, Cutler DM, Rosen AB. Forecasting the effects of obesity and smoking on U.S. life expectancy. N Engl J Med. 2009 Dec 3;361(23):2252-60. doi: 10.1056/NEJMsa0900459.
- McGinnis JM, Foege WH. Actual causes of death in the United States. JAMA. 1993 Nov 10;270(18):2207-12.
- McGinnis JM, Williams-Russo P, Knickman JR. The case for more active policy attention to health promotion. Health Aff (Millwood). 2002 Mar-Apr;21(2):78-93. doi: 10.1377/hlthaff.21.2.78.
- Schroeder SA. Shattuck Lecture. We can do better--improving the health of the American people. N Engl J Med. 2007 Sep 20;357(12):1221-8. doi: 10.1056/NEJMsa073350. No abstract available.
- Claxton G, DiJulio B, Whitmore H, Pickreign J, McHugh M, Finder B, Osei-Anto A. Job-based health insurance: costs climb at a moderate pace. Health Aff (Millwood). 2009 Nov-Dec;28(6):w1002-12. doi: 10.1377/hlthaff.28.6.w1002. Epub 2009 Sep 15.
- Heinen L, Darling H. Addressing obesity in the workplace: the role of employers. Milbank Q. 2009 Mar;87(1):101-22. doi: 10.1111/j.1468-0009.2009.00549.x.
- Finkelstein EA, Linnan LA, Tate DF, Birken BE. A pilot study testing the effect of different levels of financial incentives on weight loss among overweight employees. J Occup Environ Med. 2007 Sep;49(9):981-9. doi: 10.1097/JOM.0b013e31813c6dcb.
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- Volpp KG, John LK, Troxel AB, Norton L, Fassbender J, Loewenstein G. Financial incentive-based approaches for weight loss: a randomized trial. JAMA. 2008 Dec 10;300(22):2631-7. doi: 10.1001/jama.2008.804.
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年4月1日
一次修了 (実際)
2015年4月1日
研究の完了 (実際)
2015年4月1日
試験登録日
最初に提出
2013年2月15日
QC基準を満たした最初の提出物
2013年2月26日
最初の投稿 (見積もり)
2013年2月27日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年5月6日
QC基準を満たした最後の更新が送信されました
2015年5月4日
最終確認日
2013年12月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。