- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02564445
Using Social Incentives and Gamification for Weight Loss Promotion
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.
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. |
Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.
Participants will use a smartphone application that uses accelerometers within the phone to track step counts and receive feedback on step counts
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. |
Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.
Participants will use a smartphone application that uses accelerometers within the phone to track step counts and receive feedback on step counts
All participants will be entered with their teammate into a game that includes points and levels
Weight and step count data will be shared with the participant's primary care physician
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in weight in pounds
Time Frame: 24-week primary intervention period
|
24-week primary intervention period
|
Secondary Outcome Measures
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 823326
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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