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UPHS Weight Loss Study

4. maj 2015 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

201

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Pennsylvania
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • University of Pennsylvania

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control Arm
No other financial incentive other than for enrollment, 6-month weigh in, and completion.
Eksperimentel: 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.
Adfærdsmæssigt: Financial incentive
Eksperimentel: 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.
Adfærdsmæssigt: Financial incentive
Eksperimentel: 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.
Adfærdsmæssigt: Financial incentive

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Total pounds of weight lost
Tidsramme: 12 months
12 months

Sekundære resultatmål

Resultatmål
Tidsramme
Weight loss of 5% of initial weight
Tidsramme: 12 months
12 months

Andre resultatmål

Resultatmål
Tidsramme
Improvements in eating and physical activity habits
Tidsramme: 12 months
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Pennsylvania

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2013

Primær færdiggørelse (Faktiske)

1. april 2015

Studieafslutning (Faktiske)

1. april 2015

Datoer for studieregistrering

Først indsendt

15. februar 2013

Først indsendt, der opfyldte QC-kriterier

26. februar 2013

Først opslået (Skøn)

27. februar 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. maj 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2015

Sidst verificeret

1. december 2013

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 817128

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner