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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02564445
Other study ID # 823326
Secondary ID
Status Completed
Phase Phase 3
First received September 29, 2015
Last updated December 19, 2016
Start date January 2016
Est. completion date December 2016

Study information

Verified date December 2016
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is a 36-week, three-arm randomized, controlled trial using a team-based model to compare two weight loss programs to control. Each intervention will use insights from behavioral economics to leverage social incentives and gamification.


Description:

Obesity is a leading risk factor for morbidity and mortality affecting more than one in three adults in the United States. Modifiable health behaviors contribute to this growing epidemic. Insights from behavioral economics have shown promise for motivating behavior change through the use of financial incentives. However, social incentives or those influences that impact individuals to adjust their inherent behaviors based on social ties and connections have not been well examined. Social incentives are a more patient-centered approach that leverages and enhances the existing connections and influences on the individual. Since one individual's behavior change is connected to many others within their network, social incentives have the potential to be a scalable intervention that impacts the community. Gamification, or the use of game design in non-game situations, is often used in the real world, but its effectiveness is unknown. In this study, investigators will conduct a 36-week, three-arm, randomized, controlled trial using a team-based model to compare two weight loss programs to control. Each intervention will use insights from behavioral economics to leverage social incentives and gamification.


Recruitment information / eligibility

Status Completed
Enrollment 196
Est. completion date December 2016
Est. primary completion date September 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Age 18 to 70 years

- Ability to read and provide informed consent

- Has an iPhone 4 or newer

- Have self-reported body mass index of 30 or greater and in-person body mass index of 28 or greater

Exclusion Criteria:

- Conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write English

- Conditions that would make participation unsafe such as current treatment for drug or alcohol use, myocardial infarction or stroke within the last 6 months, metastatic cancer, pregnant, breastfeeding or plan to become pregnant during study period, previous diagnosis of an eating disorder, or history of unsafe weight loss practices

- Already enrolled in another weight loss study

- Any other medical conditions or reasons that they could not complete a 36-week weight loss program

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Gamification
All participants will be entered with their teammate into a game that includes points and levels
Share Data with PCP
Weight and step count data will be shared with the participant's primary care physician
Feedback on weight
Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.
Feedback on step counts
Participants will use a smartphone application that uses accelerometers within the phone to track step counts and receive feedback on step counts

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Outcome

Type Measure Description Time frame Safety issue
Primary Change in weight in pounds 24-week primary intervention period No
Secondary Change in weight in pounds 12-week follow-up period No
Secondary Physical activity (mean daily steps) 24-week primary intervention period No
Secondary Physical activity (mean daily steps) 12-week follow-up period No
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