Weight LossPhase 3NCT02564445
Using Social Incentives and Gamification for Weight Loss Promotion
A Phase 3 study testing Gamification, Share Data with PCP and Feedback on weight in people with Weight Loss and Obesity, run by University of Pennsylvania.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity, Physical Activity
- What is being tested?
- Gamification, Share Data with PCP and Feedback on weight
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Dec 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Weight Loss, Obesity, Physical Activity
- Being tested
- Gamification, Share Data with PCP, Feedback on weight, Feedback on step counts
- Medical subject headings
- Weight Loss, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GamificationBehavioural
All participants will be entered with their teammate into a game that includes points and levels
Share Data with PCPBehavioural
Weight and step count data will be shared with the participant's primary care physician
Feedback on weightBehavioural
Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.
Feedback on step countsBehavioural
Participants will use a smartphone application that uses accelerometers within the phone to track step counts and receive feedback on step counts
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | 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. Receives: Behavioral: Feedback on weight; Behavioral: Feedback on step counts |
| Gamification | Experimental | 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. Receives: Behavioral: Gamification; Behavioral: Feedback on weight; Behavioral: Feedback on step counts |
| Gamification + Share Data with PCP | Experimental | 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. Receives: Behavioral: Gamification; Behavioral: Share Data with PCP; Behavioral: Feedback on weight; Behavioral: Feedback on step counts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in weight in pounds
Measured: 24-week primary intervention period
Secondary outcomes (3)
Change in weight in pounds
Measured: 12-week follow-up period
Physical activity (mean daily steps)
Measured: 24-week primary intervention period
Physical activity (mean daily steps)
Measured: 12-week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mitesh Patel, MD, MBA, MS, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564445
- Sponsor's protocol ID
- 823326
- Status last verified
- Dec 2016
- First submitted
- 29 Sep 2015
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Social Incentives and Gamification for Weight Loss Promotion
- ClinicalTrials.gov ID
- NCT02564445
- Acronym / sponsor ID
- 823326
- Conditions
- Weight Loss, Obesity, Physical Activity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 30 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Behavioral: Feedback on weight, Behavioral: Feedback on step countsParticipants 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. |
| Gamification | Experimental | Behavioral: Gamification, Behavioral: Feedback on weight, Behavioral: Feedback on step countsParticipants 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. |
| Gamification + Share Data with PCP | Experimental | Behavioral: Gamification, Behavioral: Share Data with PCP, Behavioral: Feedback on weight, Behavioral: Feedback on step countsParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GamificationAll participants will be entered with their teammate into a game that includes points and levels | Behavioural | Gamification, Gamification + Share Data with PCP |
| Share Data with PCPWeight and step count data will be shared with the participant's primary care physician | Behavioural | Gamification + Share Data with PCP |
| Feedback on weightParticipants will use a wireless weight scale to weigh-in at home and receive feedback on weight. | Behavioural | Control, Gamification, Gamification + Share Data with PCP |
| Feedback on step countsParticipants will use a smartphone application that uses accelerometers within the phone to track step counts and receive feedback on step counts | Behavioural | Control, Gamification, Gamification + Share Data with PCP |
Primary outcome
Change in weight in pounds
Time frame: 24-week primary intervention period
3 secondary outcomes
Change in weight in pounds
Time frame: 12-week follow-up period
Physical activity (mean daily steps)
Time frame: 24-week primary intervention period
Physical activity (mean daily steps)
Time frame: 12-week follow-up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitesh Patel, MD, MBA, MS principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gamification, Share Data with PCP and Feedback on weight in people with Weight Loss and Obesity, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in weight in pounds (time frame: 24-week primary intervention period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2016.