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Clinical Trials/NCT05039970
NCT05039970
Completed
Not Applicable

A Real-World Study of the Effect of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program

BioCentric, Inc.1 site in 1 country550 target enrollmentSeptember 7, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus Risk
Sponsor
BioCentric, Inc.
Enrollment
550
Locations
1
Primary Endpoint
Number of Sessions Attended
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 7, 2021
End Date
October 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
BioCentric, Inc.
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of Sessions Attended

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.

Secondary Outcomes

  • Retention in National DPP 4 months and 6 months after enrollment.(6 Months)
  • Game downloads among participants randomized to the experimental arm(6 Months)
  • Daily time spent playing the serious health game in participants who downloaded the game.(Six Months)
  • Participants' game rating/Net Promoter Score or questionnaire.(Six Months)

Study Sites (1)

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