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

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ClinicalTrials.gov Identifier: NCT05039970
Recruitment Status : Recruiting
First Posted : September 10, 2021
Last Update Posted : September 10, 2021
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
BioCentric, Inc.

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Risk Diabetes Mellitus Other: WellQuest™ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 650 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will be a 2-arm parallel group cluster randomized, prospective, observational study in a real-world setting of organizations delivering the National DPP LCP. Cohorts will be randomized 1:1 to experimental or control arms. Participants in the experimental arm will download WellQuest™ and be instructed on use of the game. Participants in the control arm will proceed with routine National DPP participation. The study will focus on session attendance during the first 6 months of the 12-month program. Data will be received from 2 main sources. A secondary data analysis will be conducted on individual-level data collected by each participating organization (eg, demographics, sessions attended, body weight, minutes of physical activity). For the experimental arm only, individual-level data collected via the game use will include game downloads and daily time spent playing the game. Data on satisfaction will be collected via surveys disseminated through the game.
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : September 7, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : June 2022

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

No Intervention: Control Arm
Participants in National DPP groups randomized to the control arm will proceed with their routine National DPP participation.



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. Game downloads among participants randomized to the experimental arm [ Time Frame: 6 Months ]
    Proportion of participants who download the game

  3. Daily time spent playing the serious health game in participants who downloaded the game. [ Time Frame: Six Months ]
    Amount of time in minutes spent by participants playing the game

  4. Participants' game rating/Net Promoter Score or questionnaire. [ Time Frame: Six Months ]
    Likert scale rating of participants' satisfaction questionnaire (willingness to recommend to others)


Other Outcome Measures:
  1. Completeness of health data collected by the game [ Time Frame: 6 Months ]
    Proportion of participants reporting health data via game

  2. Comparability of health data collected by the game and data reported by the organization [ Time Frame: 6 Months ]
    Percentage of health data reported in game versus the cohort data reported to CDC

  3. Body weight (and/or body mass index [BMI]) change over time [ Time Frame: 6 Months ]
    Change in body weight measured in pounds over study duration

  4. Correlation between any weight loss (and/or BMI decrease) and game use [ Time Frame: 6 Months ]
    Change in body weight measured in pounds in proportion to game use measured in minutes

  5. Correlation of >5% weight loss and game use [ Time Frame: 6 Months ]
    Game use measured in minutes among those who achieved >5% weight loss

  6. Correlation of increased physical activity and game use [ Time Frame: 6 Months ]
    Change in physical activity measured in minutes in proportion to game use measured in minutes

  7. 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 ]
    Number of sessions in proportion to duration of game play during the first month (measured in minutes)

  8. 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 ]
    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

  9. Fitness tracker integration with the game. [ Time Frame: 6 Months ]
    Proportion of game players who link fitness tracker to the game as measured by in-game analytics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05039970


Contacts
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Contact: Kevin Jarvis, PharmD 248-922-3677 kjarvis@biocentricinc.com
Contact: Morgan Lorrilliere, PharmD 856-.669-1751 mlorrilliere@biocentricinc.com

Locations
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United States, New Jersey
BioCentric, Inc. Recruiting
Collingswood, New Jersey, United States, 08107
Contact: Kevin Jarvis, PharmD    248-922-3677    kjarvis@biocentricinc.com   
Contact: Morgan Lorrilliere, PharmD    856-669-1751    mlorrilliere@biocentricinc.com   
Sponsors and Collaborators
BioCentric, Inc.
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Kevin Jarvis, PharmD BioCentric, Inc.
Additional Information:
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Responsible Party: BioCentric, Inc.
ClinicalTrials.gov Identifier: NCT05039970    
Other Study ID Numbers: 00055024
First Posted: September 10, 2021    Key Record Dates
Last Update Posted: September 10, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BioCentric, Inc.:
Prevention
Serious Health Game
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases