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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05039970
• Other study ID #: 00055024
• Status: Completed
• Phase: N/A
• Start date: September 7, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2022
• Source: BioCentric, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: October 31, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Risk

Intervention

Other:
• WellQuest™
WellQuest™ is a mobile device-based serious health game.

Locations

Country	Name	City	State
United States	BioCentric, Inc.	Collingswood	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
BioCentric, Inc.	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Completeness of health data collected by the game	Proportion of participants reporting health data via game	6 Months
Other	Comparability of health data collected by the game and data reported by the organization	Percentage of health data reported in game versus the cohort data reported to CDC	6 Months
Other	Body weight (and/or body mass index [BMI]) change over time	Change in body weight measured in pounds over study duration	6 Months
Other	Correlation between any weight loss (and/or BMI decrease) and game use	Change in body weight measured in pounds in proportion to game use measured in minutes	6 Months
Other	Correlation of >5% weight loss and game use	Game use measured in minutes among those who achieved >5% weight loss	6 Months
Other	Correlation of increased physical activity and game use	Change in physical activity measured in minutes in proportion to game use measured in minutes	6 Months
Other	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	Number of sessions in proportion to duration of game play during the first month (measured in minutes)	6 Months
Other	Number of sessions attended in the experimental cohort among those who downloaded the game and those who did not download the game	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	6 Months
Other	Fitness tracker integration with the game.	Proportion of game players who link fitness tracker to the game as measured by in-game analytics	6 Months
Primary	Number of Sessions Attended	The primary outcome of this study is the number of sessions attended during the first 6 months following enrollment in a National DPP.	6 Months
Secondary	Retention in National DPP 4 months and 6 months after enrollment.	This outcome would be retention reported in number of sessions at 4 months and 6 months after enrollment.	6 Months
Secondary	Game downloads among participants randomized to the experimental arm	Proportion of participants who download the game	6 Months
Secondary	Daily time spent playing the serious health game in participants who downloaded the game.	Amount of time in minutes spent by participants playing the game	Six Months
Secondary	Participants' game rating/Net Promoter Score or questionnaire.	Likert scale rating of participants' satisfaction questionnaire (willingness to recommend to others)	Six Months

External Links

•   Information about the WellQuest™ game