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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.

Tracking Information
First Submitted Date  ICMJE August 12, 2021
First Posted Date  ICMJE September 10, 2021
Last Update Posted Date September 10, 2021
Actual Study Start Date  ICMJE September 7, 2021
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2021)
  • 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.
  • Game downloads among participants randomized to the experimental arm [ Time Frame: 6 Months ]
    Proportion of participants who download the game
  • 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
  • Participants' game rating/Net Promoter Score or questionnaire. [ Time Frame: Six Months ]
    Likert scale rating of participants' satisfaction questionnaire (willingness to recommend to others)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 7, 2021)
  • Completeness of health data collected by the game [ Time Frame: 6 Months ]
    Proportion of participants reporting health data via game
  • 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
  • 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
  • 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
  • Correlation of >5% weight loss and game use [ Time Frame: 6 Months ]
    Game use measured in minutes among those who achieved >5% weight loss
  • 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
  • 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)
  • 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
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
Official Title  ICMJE A Real-World Study of the Effect of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Diabetes Mellitus Risk
  • Diabetes Mellitus
Intervention  ICMJE Other: WellQuest™
WellQuest™ is a mobile device-based serious health game.
Study Arms  ICMJE
  • 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.
    Intervention: Other: WellQuest™
  • No Intervention: Control Arm
    Participants in National DPP groups randomized to the control arm will proceed with their routine National DPP participation.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 7, 2021)
650
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date November 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kevin Jarvis, PharmD 248-922-3677 kjarvis@biocentricinc.com
Contact: Morgan Lorrilliere, PharmD 856-.669-1751 mlorrilliere@biocentricinc.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05039970
Other Study ID Numbers  ICMJE 00055024
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party BioCentric, Inc.
Study Sponsor  ICMJE BioCentric, Inc.
Collaborators  ICMJE Centers for Disease Control and Prevention
Investigators  ICMJE
Principal Investigator: Kevin Jarvis, PharmD BioCentric, Inc.
PRS Account BioCentric, Inc.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP