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Completed

NCT Number: NCT05039970

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioCentric, Inc.

Collingswood, New Jersey, 08107, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

WellQuest™

Other

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

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

BioCentric, Inc.

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2021
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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