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

NCT05039970 | Completed

• 1 other identifier: 00055024
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Risk; Diabetes Mellitus

Keywords

Prevention; Serious Health Game

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Other Outcomes (9)

• Completeness of health data collected by the game

  6 Months

• Comparability of health data collected by the game and data reported by the organization

  6 Months

• Body weight (and/or body mass index [BMI]) change over time

  6 Months

Study Arms (2)

Experimental Arm - WellQuest™ Users

EXPERIMENTAL

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™

Control Arm

NO INTERVENTION

Participants in National DPP groups randomized to the control arm will proceed with their routine National DPP participation.

Interventions

WellQuest™ OTHER

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

Experimental Arm - WellQuest™ Users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Participants cannot have a previous diagnosis of type 1 or type 2 diabetes, prior to enrollment in a National DPP.

Sponsors & Collaborators

• BioCentric, Inc.: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

BioCentric, Inc.

Collingswood, New Jersey, 08107, United States

Location

Related Links

• Information about the WellQuest™ game

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Kevin Jarvis, PharmD

  BioCentric, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: September 10, 2021
• Study Start: September 7, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)