- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01167634
University Of Pennsylvania Weight Loss Study
This is a 4-arm, randomized controlled trial to evaluate the effectiveness of financial incentives to motivate and sustain long-term weight loss. The study will recruit eligible employees at a large health management company to participate in a 6-month weight loss program and have weight measurements for an additional 3-month follow-up period. The primary outcome measure in this randomized controlled trial will be pounds of weight lost. The experimental groups will include variations of deposit contracts (participants put their own money at risk, and lose that money if they fail to achieve their weight loss goal) and fixed payments. The use of deposit contracts is a powerful mechanism for inducing behavior change that is based on loss aversion, a psychological concept first described by Nobel Prize winner Daniel Kahneman and Amos Tversky in 1979. A deposit contract takes advantage of the fact that people typically feel the pain of a loss more than the pleasure of a gain, increasing ones motivation to reach a goal.
The study hypotheses are 1) mean weight loss will be greater in all intervention groups compared to the control group by the end of 24 weeks; and 2) individuals in the intervention groups will have a lower mean weight at the end of the 3-month follow-up period than individuals in the control group.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Aged 18 to 70 (inclusive)
- BMI between 30 and 50 (inclusive)
Exclusion Criteria:
- Inability to consent
- No known Illiteracy and/or inability to speak, read, and write English
- Participation in another weight loss program
- 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
- Uncontrolled hypertension (defined as BP170 mm Hg systolic or BP110 mm Hg diastolic)
- Current addiction to prescription medicines or street drugs
- Serious psychiatric diagnoses (severe depression, schizophrenia)
- Pregnancy
- Diabetic and using any medicine besides metformin to control blood sugars
- 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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: 1
|
|
|
Eksperimentel: 2
Deposit contract with a 1:1 match
|
Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount.
Final weigh-in at 36 weeks with no financial incentive or deposit made.
|
|
Eksperimentel: 3
Deposit contract with a 2:1 match
|
Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount.
Final weigh-in at 36 weeks with no financial incentive or deposit made.
|
|
Eksperimentel: Experimental 4
Deposit contract with no match
|
Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back.
Final weigh-in at 36 weeks with no financial incentive or deposit made.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Weight
Tidsramme: 24 Weeks
|
Change in weight between baseline and 24 weeks
|
24 Weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: George Loewenstein, PhD, Carnegie Mellon University
- Studiestol: Kevin G. Volpp, MD, PhD, University of Pennsylvania
- Studieleder: Heather Schofield, MS, Harvard University
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 813407
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 .
Kliniske forsøg med Deposit contract with a 1:1 match
-
CooperVision, Inc.Afsluttet
-
CooperVision, Inc.Afsluttet
-
CooperVision, Inc.Afsluttet
-
Johnson & Johnson Vision Care, Inc.Afsluttet
-
Johnson & Johnson Vision Care, Inc.Afsluttet
-
Johnson & Johnson Vision Care, Inc.Afsluttet
-
Roswell Park Cancer InstituteTrukket tilbage
-
National Center for Research Resources (NCRR)Louisiana State University Health Sciences Center in New OrleansUkendtSystemisk lupus erythematosusForenede Stater
-
CooperVision, Inc.AfsluttetNærsynethedForenede Stater
-
CooperVision International Limited (CVIL)Indiana UniversityIkke rekrutterer endnu