BioCentric, Inc.
Collingswood, New Jersey, 08107, United States
NCT Number: NCT05039970
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Collingswood, New Jersey, 08107, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
WellQuest™ is a mobile device-based serious health game.
Time frame: 6 Months
The primary outcome of this study is the number of sessions attended during the first 6 months following enrollment in a National DPP.
Time frame: 6 Months
This outcome would be retention reported in number of sessions at 4 months and 6 months after enrollment.
Time frame: 6 Months
Proportion of participants who download the game
Time frame: Six Months
Amount of time in minutes spent by participants playing the game
Time frame: Six Months
Likert scale rating of participants' satisfaction questionnaire (willingness to recommend to others)
Time frame: 6 Months
Proportion of participants reporting health data via game
Time frame: 6 Months
Percentage of health data reported in game versus the cohort data reported to CDC
Time frame: 6 Months
Change in body weight measured in pounds over study duration
Time frame: 6 Months
Change in body weight measured in pounds in proportion to game use measured in minutes
Time frame: 6 Months
Game use measured in minutes among those who achieved >5% weight loss
Time frame: 6 Months
Change in physical activity measured in minutes in proportion to game use measured in minutes
Time frame: 6 Months
Number of sessions in proportion to duration of game play during the first month (measured in minutes)
Time frame: 6 Months
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
Time frame: 6 Months
Proportion of game players who link fitness tracker to the game as measured by in-game analytics
BioCentric, Inc.
Other
A Real-World Study of the Effect of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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