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- Register voor klinische proeven in de VS.
- Klinische proef NCT03566277
Project Step: Evaluating Deposit Contracts and Daily Feedback to Promote Walking in Overweight and Obese Adults
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
Approximately 68% of adults are overweight or obese, which is associated with increased risk for health conditions, including cardiovascular disease, type 2 diabetes, and cancer. These individuals are more often sedentary than the general population, which compounds the risk for these same conditions. While the benefits of engaging in physical activity are well-established, few individuals are able to successfully increase activity to recommended levels. Existing intervention programs, often derived from theories such as social cognitive theory or related theories, have had limited success. Behavioral economics offers a promising alternative, suggesting that engagement in any behavior is based on the maximizing utility and happiness. Interventions based on this theory aim to increase the immediate benefit of engaging in physical activity, often using a financial incentive.
This study will last for 16 weeks. Each participant will invest $42 with the study, and be exposed to to each of three interventions. All participants will have the use of a FitBit for ongoing self-monitoring and a step-count goal of 10,000 steps per day. In one condition, these will be the only interventions you receive. In one condition, you will receive a monetary consequence for meeting or not meeting the goal. Each day during the incentive conditions, you will be eligible to lose $0.75 of your own money for not meeting the goal, or to earn back $0.75 of your money plus $0.75 from the study (i.e., a total of $1.50) for meeting the goal. In the third condition, you will have daily feedback mid-afternoon about your distance from the goal and the money you stand to gain or lose. You will be made aware of what condition you are in.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- 25 kg/m2 ≤ BMI ≤ 45 kg/m2
- Age 18-70
- Currently inactive (engages in less than 6,000 steps/day on at least 4 of 7 days per week, confirmed by FitBit at baseline)
- Able to engage in moderate amount of walking
- Able to receive email/text messages from study staff
Exclusion Criteria:
- medical or psychiatric conditions that would make it difficult to comply with study protocols
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Single-arm trial
All participants will undergo each of three conditions during the study.
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Participants will have access to a wrist-worn activity monitor and have a daily step goal
Participants will have a deposit contract, wherein they will lose money if a goal is not reached, or double their money if a goal is reached
Participants will receive text message feedback each day about progress towards their goal
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Step counts
Tijdsspanne: Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)
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Daily number of steps taken
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Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)
|
Goal attainment
Tijdsspanne: Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)
|
Proportion of days step goal was met
|
Throughout 16-week study, measured as the average of each two-week block (i.e., each time condition changes)
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1601004185-1
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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