- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05039970
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
A Real-World Study of the Effect of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
The overall prevalence of type 2 diabetes in the United States (US) is estimated at more than 30 million people, with an estimated 88 million more adults meeting the criteria for having prediabetes and being at risk for progressing to type 2 diabetes. The significant burden of diabetes, as well as the high individual and societal cost it bears, renders this disease among the highest public health priorities for the health authorities and policy makers. In response to the rising diabetes prevalence, the US Centers for Disease Control and Prevention (CDC) established the National Diabetes Prevention Program (National DPP) in 2010 as a framework for diabetes prevention by providing evidence-based, affordable, and high-quality lifestyle change programs (LCPs). The National DPP LCP is a yearlong education-based curriculum focused on achieving modest weight loss (5% to 7%) and increasing participants' physical activity to reduce the risk of progressing to type 2 diabetes. To ensure high-quality programs and meaningful impact on participants, the CDC sets standards for organizations that wish to offer an LCP through the Diabetes Prevention Recognition Program (DPRP). The DPRP plays a critical role in ensuring that organizations can effectively deliver the evidence-based lifestyle change program with quality and fidelity. To achieve recognition status, organizations must periodically provide evidence that they are following a CDC-approved curriculum and achieving meaningful results on session attendance, body weight change, and physical activity minutes.
A recent analysis of National DPP data has shown that the attrition rates in this program are substantial and that they differ by age and race. Moreover, the attrition rates were inversely associated with the program success, as reflected by the LCP outcomes, and, specifically, participants' weight and level of physical activity. In view of these findings, the CDC is undertaking an effort to increase participant retention in the National DPP.
The proposed study will evaluate the pilot use of a free-of-charge mobile device-based serious health game (WellQuest™) within the frame of the National DPP LCP. WellQuest™ was designed with the goals to improve participant engagement and retention in the LCP, to encourage adoption and maintenance of healthy lifestyle habits among LCP participants, and to reinforce knowledge of the LCP curriculum.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New Jersey
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Collingswood, New Jersey, United States, 08107
- BioCentric, Inc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Enrollment in a qualifying National DPP program
- Body mass index (BMI) ≥25 kg/m2 for non-Asians and ≥23 kg/m2 for Asians.
- Have prediabetes identified by either a blood test or a self-reported risk test or have a history of gestational diabetes mellitus (GDM).
Exclusion Criteria:
- Participants cannot have a previous diagnosis of type 1 or type 2 diabetes, prior to enrollment in a National DPP.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Experimental Arm - WellQuest™ Users
Participants in National DPP groups randomized to the experimental arm will be instructed by lifestyle coaches to download the WellQuest™ game application and will receive instructions on how to use the game throughout the LCP.
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WellQuest™ is a mobile device-based serious health game.
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No Intervention: Control Arm
Participants in National DPP groups randomized to the control arm will proceed with their routine National DPP participation.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Sessions Attended
Time Frame: 6 Months
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The primary outcome of this study is the number of sessions attended during the first 6 months following enrollment in a National DPP.
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6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Retention in National DPP 4 months and 6 months after enrollment.
Time Frame: 6 Months
|
This outcome would be retention reported in number of sessions at 4 months and 6 months after enrollment.
|
6 Months
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Game downloads among participants randomized to the experimental arm
Time Frame: 6 Months
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Proportion of participants who download the game
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6 Months
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Daily time spent playing the serious health game in participants who downloaded the game.
Time Frame: Six Months
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Amount of time in minutes spent by participants playing the game
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Six Months
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Participants' game rating/Net Promoter Score or questionnaire.
Time Frame: Six Months
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Likert scale rating of participants' satisfaction questionnaire (willingness to recommend to others)
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Six Months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completeness of health data collected by the game
Time Frame: 6 Months
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Proportion of participants reporting health data via game
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6 Months
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Comparability of health data collected by the game and data reported by the organization
Time Frame: 6 Months
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Percentage of health data reported in game versus the cohort data reported to CDC
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6 Months
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Body weight (and/or body mass index [BMI]) change over time
Time Frame: 6 Months
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Change in body weight measured in pounds over study duration
|
6 Months
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Correlation between any weight loss (and/or BMI decrease) and game use
Time Frame: 6 Months
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Change in body weight measured in pounds in proportion to game use measured in minutes
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6 Months
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Correlation of >5% weight loss and game use
Time Frame: 6 Months
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Game use measured in minutes among those who achieved >5% weight loss
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6 Months
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Correlation of increased physical activity and game use
Time Frame: 6 Months
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Change in physical activity measured in minutes in proportion to game use measured in minutes
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6 Months
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Correlation between retention in National DPP 6 months after enrollment and the amount of time spent playing the serious health game during the first month after enrollment
Time Frame: 6 Months
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Number of sessions in proportion to duration of game play during the first month (measured in minutes)
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6 Months
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Number of sessions attended in the experimental cohort among those who downloaded the game and those who did not download the game
Time Frame: 6 Months
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Number of sessions attended as reported by the CDC among those who did and did not download the game as measured by number of downloads
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6 Months
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Fitness tracker integration with the game.
Time Frame: 6 Months
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Proportion of game players who link fitness tracker to the game as measured by in-game analytics
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6 Months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Kevin Jarvis, PharmD, BioCentric, Inc.
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 00055024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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