Diabetes Mellitus RiskNCT05039970
A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program
A study testing WellQuest™ in people with Diabetes Mellitus Risk and Diabetes Mellitus, run by BioCentric, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus Risk, Diabetes Mellitus
- What is being tested?
- WellQuest™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 550 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Participants cannot have a previous diagnosis of type 1 or type 2 diabetes, prior to enrollment in a National DPP.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- WellQuest™
- Keywords
- Prevention, Serious Health Game
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WellQuest™Other
WellQuest™ is a mobile device-based serious health game.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: WellQuest™ |
| Control Arm | No intervention | Participants in National DPP groups randomized to the control arm will proceed with their routine National DPP participation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 Months
Secondary outcomes (4)
Retention in National DPP 4 months and 6 months after enrollment.
This outcome would be retention reported in number of sessions at 4 months and 6 months after enrollment.
Measured: 6 Months
Game downloads among participants randomized to the experimental arm
Proportion of participants who download the game
Measured: 6 Months
Daily time spent playing the serious health game in participants who downloaded the game.
Amount of time in minutes spent by participants playing the game
Measured: Six Months
Participants' game rating/Net Promoter Score or questionnaire.
Likert scale rating of participants' satisfaction questionnaire (willingness to recommend to others)
Measured: Six Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
- Study start7 Sep 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus RiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 550 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCentric, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Kevin Jarvis, PharmD, Principal investigator, BioCentric, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039970
- Sponsor's protocol ID
- 00055024
- Status last verified
- Oct 2022
- First submitted
- 12 Aug 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05039970
- Acronym / sponsor ID
- 00055024
- Conditions
- Diabetes Mellitus Risk, Diabetes Mellitus
- Keywords
- Prevention, Serious Health Game
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 550 participants (actual)
- Lead sponsor
- BioCentric, Inc.University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 10 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm - WellQuest™ Users | Experimental | Other: WellQuest™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. |
| Control Arm | No intervention | –Participants in National DPP groups randomized to the control arm will proceed with their routine National DPP participation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Participants cannot have a previous diagnosis of type 1 or type 2 diabetes, prior to enrollment in a National DPP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WellQuest™WellQuest™ is a mobile device-based serious health game. | Other | Experimental Arm - WellQuest™ Users |
Primary outcome
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.
4 secondary outcomes
Retention in National DPP 4 months and 6 months after enrollment.
Time frame: 6 Months
Game downloads among participants randomized to the experimental arm
Time frame: 6 Months
Daily time spent playing the serious health game in participants who downloaded the game.
Time frame: Six Months
Participants' game rating/Net Promoter Score or questionnaire.
Time frame: Six Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Information about the WellQuest™ gameLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Jarvis, PharmD principal investigator
BioCentric, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WellQuest™ in people with Diabetes Mellitus Risk and Diabetes Mellitus, run by BioCentric, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Sessions Attended (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.