Using Social Incentives and Gamification for Weight Loss Promotion

December 19, 2016 updated by: University of Pennsylvania
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
196

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Control

Participants choose a weight loss goal of 6-8% of baseline weight and given access to a wireless weight scale and smartphone application activity tracker to receive feedback on weight and feedback on step counts.

They will be given information on the federal and CDC guidelines for physical activity and will also be told that they should strive to achieve 10,000 steps per day to help promote weight loss.
Behavioral: Feedback on weight
Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.
Behavioral: 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
Experimental: Gamification

Participants choose a weight loss goal of 6-8% of baseline weight and given access to a wireless weight scale and smartphone application activity tracker to receive feedback on weight and feedback on step counts.

All participants play a game with their teammate that includes points, levels and the opportunity to win a trophy, plaque or medal. They will advance or not advance based on their progress with weight loss and physical activity through 24 weeks. During the 12-week follow-up they'll be asked to maintain or make progress toward their weight loss goal.
Behavioral: Feedback on weight
Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.
Behavioral: 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
Behavioral: Gamification
All participants will be entered with their teammate into a game that includes points and levels
Experimental: Gamification + Share Data with PCP

Participants choose a weight loss goal of 6-8% of baseline weight and given access to a wireless weight scale and smartphone application activity tracker to receive feedback on weight and feedback on step counts.

Participants will be asked to allow the study team to share their weight and step data with their primary care physician (PCP).

All participants play a game with their teammate that includes points, levels and the opportunity to win a trophy, plaque or medal. They will advance or not advance based on their progress with weight loss and physical activity through 24 weeks. During the 12-week follow-up they'll be asked to maintain or make progress toward their weight loss goal.
Behavioral: Feedback on weight
Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.
Behavioral: 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
Behavioral: Gamification
All participants will be entered with their teammate into a game that includes points and levels
Behavioral: Share Data with PCP
Weight and step count data will be shared with the participant's primary care physician

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in weight in pounds
Time Frame: 24-week primary intervention period
24-week primary intervention period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in weight in pounds
Time Frame: 12-week follow-up period
12-week follow-up period
Physical activity (mean daily steps)
Time Frame: 24-week primary intervention period
24-week primary intervention period
Physical activity (mean daily steps)
Time Frame: 12-week follow-up period
12-week follow-up period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 823326

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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