Clinical trial NCT05039970: A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Risk
Diabetes Mellitus
Keywords: Prevention
Serious Health Game
Lead sponsor: BioCentric, Inc.
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-09-10
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Number of Sessions Attended
timeFrame: 6 Months
Secondary outcomes:
measure: Retention in National DPP 4 months and 6 months after enrollment.
timeFrame: 6 Months
measure: Game downloads among participants randomized to the experimental arm
timeFrame: 6 Months
measure: Daily time spent playing the serious health game in participants who downloaded the game.
timeFrame: Six Months
measure: Participants' game rating/Net Promoter Score or questionnaire.
timeFrame: Six Months
Other outcomes:
measure: Completeness of health data collected by the game
timeFrame: 6 Months
measure: Comparability of health data collected by the game and data reported by the organization
timeFrame: 6 Months
measure: Body weight (and/or body mass index [BMI]) change over time
timeFrame: 6 Months
measure: Correlation between any weight loss (and/or BMI decrease) and game use
timeFrame: 6 Months
measure: Correlation of >5% weight loss and game use
timeFrame: 6 Months
measure: Correlation of increased physical activity and game use
timeFrame: 6 Months
measure: 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
timeFrame: 6 Months
measure: Number of sessions attended in the experimental cohort among those who downloaded the game and those who did not download the game
timeFrame: 6 Months
measure: Fitness tracker integration with the game.
timeFrame: 6 Months
Locations:
city: Collingswood
country: United States
facility: BioCentric, Inc.
state: New Jersey
Study officials:
affiliation: BioCentric, Inc.
name: Kevin Jarvis, PharmD
role: PRINCIPAL_INVESTIGATOR
References: