Diabetes Mellitus, Type 2NCT04746781
The Effect of 360 Video and MAPS on Enrollment in the DPP
A study testing Mobile 360° Video intervention, Motivation and Problem Solving (MAPS) and Risk notification/education in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by University of Utah at 1 site in United States.
Trial summary
We will conduct a three-armed randomized, clinical trial to test the incremental effectiveness of Mobile 360° Video and Motivation and Problem Solving in motivating individuals with Prediabetes to enroll in the Diabetes Prevention Program. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, PreDiabetes
- What is being tested?
- Mobile 360° Video intervention, Motivation and Problem Solving (MAPS) and Risk notification/education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 818 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2021to 15 Dec 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are aged 18-89
- Have a diagnosis of prediabetes within the past 5 years (ICD-10 code R73.03)
- Have an email and mobile telephone number on record with the Health-system
- Primary language of either English or Spanish
Who cannot join
- Type 2 diabetes mellitus (ICD-10-CM E11);
- Type 1 diabetes mellitus (ICD-10-CM Diagnosis E10),
- Diabetes mellitus due to underlying condition (ICD-10 E08);
- Drug or chemical induced diabetes mellitus (ICD-10 E09);
- Gestational diabetes (ICD-10 024.4);
- Neonatal diabetes mellitus (ICD-10 P70.2);
- Post-pancreatectomy diabetes mellitus (ICD-10 E13).
- Patients whose primary language is other than Spanish or English will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mobile Immersive Video and Motivation and Problem Solving on Enrollment in the Diabetes Prevention Program
We will conduct a three-armed randomized, clinical trial to test the incremental effectiveness of Mobile 360° Video and Motivation and Problem Solving in motivating individuals with Prediabetes to enroll in the Diabetes Prevention Program. all participants will receive notification that they have Prediabetes and education about Prediabetes, Type 2 diabetes, and the Diabetes Prevention Program, some participants will receive the additional interventions
Read the detailed description
More than 88 million Americans are at risk of developing Type 2 diabetes mellitus (T2DM). The one-year Diabetes Prevention Program (DPP) has been shown to be effective in reducing the risk of progressing from prediabetes to T2DM. However, most individuals who could benefit from the program never enroll.
Prior research has elucidated several reasons people do not enroll in the DPP. First, many people are not aware that they are at risk of developing T2DM, or that an efficacious program like the DPP exists. Second, the complications from T2DM are abstract, distal and difficult to imagine, which in turn leads to low motivation for risk-reducing behaviors. Finally, practical barriers limit DPP enrollment including cost, travel time, and scheduling. Prior research has tested rational appeals (such as provider-based education and referral) to enroll individuals in the DPP, with limited efficacy. In this project we will compare the effects of notification and education alone, notification and education plus mobile phone delivered videos (emotional appeal), and notification and education plus phone-based coaching utilizing a motivation and problem-solving approach. Our primary outcome will be enrollment and 1-month engagement in the DPP.
This three-armed randomized, clinical trial will be conducted within 2 health systems. Following an opt-out procedure offered to all eligible participants, participants will complete informed consent and a baseline survey. In the risk notification/education arm, we will send all participants a short message service (SMS) message with a link to a website that educates the public about their risk for developing T2DM and about the availability and efficacy of the DPP to address their risk. In the Mobile 360° Video intervention arm, after risk notification/education, participants will receive links to two 3-minute immersive Mobile 360° Videos (in which the viewer moves their phone to 'look around' the world of the video) on their smart phones. These videos are intended to influence affective and experiential perceptions of risk. The first video tells an emotional story of the negative effects on an individual's health and family life as they progress from prediabetes to T2DM and develop cardiovascular complications. The second video provides the viewer with a vicarious experience of the changes in vision that occur as diabetic retinopathy develops and worsens.
In the Motivation and Problem Solving (MAPS) arm, after risk notification/education, participants will be called by a health coach trained in counseling/coaching. The coach will guide them in setting health related goals and addressing any practical barriers to enrolling/engaging in the DPP, if that is consistent with their health goals.
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Being tested
- Mobile 360° Video intervention, Motivation and Problem Solving (MAPS), Risk notification/education
- Medical subject headings
- Diabetes Mellitus, Type 2, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile 360° Video interventionBehavioural
Using 360° Videos to educate participants about the effect of diabetes.
Motivation and Problem Solving (MAPS)Behavioural
Using Motivation and Problem Solving to help people enroll in the Diabetes Prevention Program.
Risk notification/educationBehavioural
Sending participants (all of whom meet the diagnostic criteria for prediabetes) educational information about the condition.
| Study group | Role | What they receive |
|---|---|---|
| Risk notification/education arm | Active comparator | We will send all participants a short message service (SMS) message with a link to a website that educates the public about their risk for developing T2DM and about the availability and efficacy of the DPP to address their risk Receives: Behavioral: Risk notification/education |
| Mobile 360° Video intervention arm | Experimental | After risk notification and education, participants will receive links to two 3-minute immersive Mobile 360° Videos (in which the viewer moves their phone to 'look around' the world of the video) on their smart phones. These videos are intended to influence affective and experiential perceptions of risk. The first video tells an emotional story of the negative effects on an individual's health and family life as they progress from prediabetes to T2DM and develop cardiovascular complications. The second video provides the viewer with a vicarious experience of the changes in vision that occur as diabetic retinopathy develops and worsens. Receives: Behavioral: Mobile 360° Video intervention; Behavioral: Risk notification/education |
| Motivation and Problem Solving (MAPS) arm | Experimental | After risk notification and education, participants will be called by a health coach trained in counseling/coaching. The coach will guide them in setting goals related to their health, and addressing any practical barriers to enrolling/engaging in the DPP if that is consistent with their health goals. Per their preference, participants will receive up to 5 phone calls from the health coach over a 4 week period. Receives: Behavioral: Motivation and Problem Solving (MAPS); Behavioral: Risk notification/education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes prevention program enrollment
Enrollment in the Diabetes prevention program . This data that is recorded by all Diabetes prevention programs and is required to be reported to the Centers for disease control. For individuals attending an in person-class. It is defined by the CDC as registration for the program. For individuals who enroll in an online DPP it is defined by the CDC as an individual setting their password for the app. For the purposes of this trial any individual meeting either of these criteria will be considered to have enrolled in the DPP.
Measured: 1-month
4 weeks of engagement in the Diabetes prevention program
1-month engagement in the Diabetes prevention program. This is data that is recorded by all Diabetes prevention programs and is required to be reported to the Centers for Disease Control. For individuals attending an in person-class, it is defined by the CDC as the individual attending at least 2 of the first four sessions. For individuals who enroll in an online DPP it is defined by the CDC as completing at least two of the following activities: (A) Complete two education modules (B) Send at least 1 In-App message and/or Group Wall post (C) Set or log at least one behavior (D) Log, plan or research at least three meals (E) Log physical activity at least three (F) Weigh-in on three or more days in two out of the first four weeks
For the purposes of this trial any individual meeting either of these criteria will be considered to have engaged in the DPP for the first month.
Measured: 1 month
Secondary outcomes (2)
Changes in self-efficacy
Self-efficacy related to Diabetes prevention program participation as well as diet, exercise, and weight loss will be measured using the brief (16 items) Self-Efficacy scales adapted from Wilson 2016:
Wilson KE, Harden SM, Almeida FA, et al. Brief self-efficacy scales for use in weight-loss trials: Preliminary evidence of validity. Psychological assessment 2016; 28(10): 1255-64.
This will be measured pre and post intervention and the change score calculated and compared across intervention arms
Measured: 1 month
Changes in Risk perceptions
Risk perceptions related to development of Type 2 Diabetes will be measured using an 18-item measure of risk perceptions for Type 2 diabetes developed by Ferrer et al:
Ferrer RA, Klein WMP, Persoskie A, Avishai-Yitshak A, Sheeran P. The Tripartite Model of Risk Perception (TRIRISK): Distinguishing Deliberative, Affective, and Experiential Components of Perceived Risk. Annals of Behavioral Medicine 2016; 50(5): 653-63.
This measure includes 6 items each to measure three different aspects of risk perception: deliberative, affective and experiential risk perceptions. we will calculate the sub scores for these dimensions and compare changes in them across intervention arms
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start17 Feb 2021
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 818 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Bryan Smith Gibson, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746781
- Sponsor's protocol ID
- 00132307
- Status last verified
- May 2023
- First submitted
- 1 Feb 2021
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kent-Marvick J, Knysheva M, Gibson B, Simonsen SE. Why Do People Choose to Enroll or Not Enroll in the National Diabetes Prevention Program Lifestyle Change Program? A Mixed-Methods Analysis From a Sample of Adults With a Prediabetes Diagnosis. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241282862. doi: 10.1177/21501319241282862.
PubMed 39305089Gibson B, Simonsen S, Barton J, Zhang Y, Altizer R, Lundberg K, Wetter DW. Motivation and Problem Solving Versus Mobile 360 degrees Videos to Promote Enrollment in the National Diabetes Prevention Program's Lifestyle Change Program Among People With Prediabetes: Protocol for a Randomized Trial. JMIR Res Protoc. 2021 Jun 14;10(6):e28884. doi: 10.2196/28884.
PubMed 34125075
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mobile Immersive Video and Motivation and Problem Solving on Enrollment in the Diabetes Prevention Program
- ClinicalTrials.gov ID
- NCT04746781
- Acronym / sponsor ID
- 00132307
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 818 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- 17 Feb 2021 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 10 Feb 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.
We will conduct a three-armed randomized, clinical trial to test the incremental effectiveness of Mobile 360° Video and Motivation and Problem Solving in motivating individuals with Prediabetes to enroll in the Diabetes Prevention Program. all participants will receive notification that they have Prediabetes and education about Prediabetes, Type 2 diabetes, and the Diabetes Prevention Program, some participants will receive the additional interventions
Detailed description
More than 88 million Americans are at risk of developing Type 2 diabetes mellitus (T2DM). The one-year Diabetes Prevention Program (DPP) has been shown to be effective in reducing the risk of progressing from prediabetes to T2DM. However, most individuals who could benefit from the program never enroll.
Prior research has elucidated several reasons people do not enroll in the DPP. First, many people are not aware that they are at risk of developing T2DM, or that an efficacious program like the DPP exists. Second, the complications from T2DM are abstract, distal and difficult to imagine, which in turn leads to low motivation for risk-reducing behaviors. Finally, practical barriers limit DPP enrollment including cost, travel time, and scheduling. Prior research has tested rational appeals (such as provider-based education and referral) to enroll individuals in the DPP, with limited efficacy. In this project we will compare the effects of notification and education alone, notification and education plus mobile phone delivered videos (emotional appeal), and notification and education plus phone-based coaching utilizing a motivation and problem-solving approach. Our primary outcome will be enrollment and 1-month engagement in the DPP.
This three-armed randomized, clinical trial will be conducted within 2 health systems. Following an opt-out procedure offered to all eligible participants, participants will complete informed consent and a baseline survey. In the risk notification/education arm, we will send all participants a short message service (SMS) message with a link to a website that educates the public about their risk for developing T2DM and about the availability and efficacy of the DPP to address their risk. In the Mobile 360° Video intervention arm, after risk notification/education, participants will receive links to two 3-minute immersive Mobile 360° Videos (in which the viewer moves their phone to 'look around' the world of the video) on their smart phones. These videos are intended to influence affective and experiential perceptions of risk. The first video tells an emotional story of the negative effects on an individual's health and family life as they progress from prediabetes to T2DM and develop cardiovascular complications. The second video provides the viewer with a vicarious experience of the changes in vision that occur as diabetic retinopathy develops and worsens.
In the Motivation and Problem Solving (MAPS) arm, after risk notification/education, participants will be called by a health coach trained in counseling/coaching. The coach will guide them in setting health related goals and addressing any practical barriers to enrolling/engaging in the DPP, if that is consistent with their health goals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Risk notification/education arm | Active comparator | Behavioral: Risk notification/educationWe will send all participants a short message service (SMS) message with a link to a website that educates the public about their risk for developing T2DM and about the availability and efficacy of the DPP to address their risk |
| Mobile 360° Video intervention arm | Experimental | Behavioral: Mobile 360° Video intervention, Behavioral: Risk notification/educationAfter risk notification and education, participants will receive links to two 3-minute immersive Mobile 360° Videos (in which the viewer moves their phone to 'look around' the world of the video) on their smart phones. These videos are intended to influence affective and experiential perceptions of risk. The first video tells an emotional story of the negative effects on an individual's health and family life as they progress from prediabetes to T2DM and develop cardiovascular complications. The second video provides the viewer with a vicarious experience of the changes in vision that occur as diabetic retinopathy develops and worsens. |
| Motivation and Problem Solving (MAPS) arm | Experimental | Behavioral: Motivation and Problem Solving (MAPS), Behavioral: Risk notification/educationAfter risk notification and education, participants will be called by a health coach trained in counseling/coaching. The coach will guide them in setting goals related to their health, and addressing any practical barriers to enrolling/engaging in the DPP if that is consistent with their health goals. Per their preference, participants will receive up to 5 phone calls from the health coach over a 4 week period. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are aged 18-89
- Have a diagnosis of prediabetes within the past 5 years (ICD-10 code R73.03)
- Have an email and mobile telephone number on record with the Health-system
- Primary language of either English or Spanish
Key exclusion criteria (8 listed)
- Type 2 diabetes mellitus (ICD-10-CM E11);
- Type 1 diabetes mellitus (ICD-10-CM Diagnosis E10),
- Diabetes mellitus due to underlying condition (ICD-10 E08);
- Drug or chemical induced diabetes mellitus (ICD-10 E09);
- Gestational diabetes (ICD-10 024.4);
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 |
|---|---|---|
| Mobile 360° Video interventionUsing 360° Videos to educate participants about the effect of diabetes. | Behavioural | Mobile 360° Video intervention arm |
| Motivation and Problem Solving (MAPS)Using Motivation and Problem Solving to help people enroll in the Diabetes Prevention Program. | Behavioural | Motivation and Problem Solving (MAPS) arm |
| Risk notification/educationSending participants (all of whom meet the diagnostic criteria for prediabetes) educational information about the condition. | Behavioural | Mobile 360° Video intervention arm, Motivation and Problem Solving (MAPS) arm, Risk notification/education arm |
Primary outcome
Diabetes prevention program enrollment
Time frame: 1-month
Enrollment in the Diabetes prevention program . This data that is recorded by all Diabetes prevention programs and is required to be reported to the Centers for disease control. For individuals attending an in person-class. It is defined by the CDC as registration for the program. For individuals who enroll in an online DPP it is defined by the CDC as an individual setting their password for the app. For the purposes of this trial any individual meeting either of these criteria will be considered to have enrolled in the DPP.
4 weeks of engagement in the Diabetes prevention program
Time frame: 1 month
1-month engagement in the Diabetes prevention program. This is data that is recorded by all Diabetes prevention programs and is required to be reported to the Centers for Disease Control. For individuals attending an in person-class, it is defined by the CDC as the individual attending at least 2 of the first four sessions. For individuals who enroll in an online DPP it is defined by the CDC as completing at least two of the following activities: (A) Complete two education modules (B) Send at least 1 In-App message and/or Group Wall post (C) Set or log at least one behavior (D) Log, plan or research at least three meals (E) Log physical activity at least three (F) Weigh-in on three or more days in two out of the first four weeks For the purposes of this trial any individual meeting either of these criteria will be considered to have engaged in the DPP for the first month.
2 secondary outcomes
Changes in self-efficacy
Time frame: 1 month
Changes in Risk perceptions
Time frame: 1 month
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 22 May 2023.
- Derived from this study: PubMed 39305089Kent-Marvick J, Knysheva M, Gibson B, Simonsen SE. Why Do People Choose to Enroll or Not Enroll in the National Diabetes Prevention Program Lifestyle Change Program? A Mixed-Methods Analysis From a Sample of Adults With a Prediabetes Diagnosis. J Prim Care Community Health. 2024 Jan-Dec;15:21501319241282862. doi: 10.1177/21501319241282862.
- Derived from this study: PubMed 34125075Gibson B, Simonsen S, Barton J, Zhang Y, Altizer R, Lundberg K, Wetter DW. Motivation and Problem Solving Versus Mobile 360 degrees Videos to Promote Enrollment in the National Diabetes Prevention Program's Lifestyle Change Program Among People With Prediabetes: Protocol for a Randomized Trial. JMIR Res Protoc. 2021 Jun 14;10(6):e28884. doi: 10.2196/28884.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile 360° Video intervention, Motivation and Problem Solving (MAPS) and Risk notification/education in people with Diabetes Mellitus, Type 2 and PreDiabetes, run by University of Utah 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 4 inclusion and 8 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 22 May 2023. 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?
Diabetes prevention program enrollment (time frame: 1-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746781, which also lists 2 linked publications.
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 22 May 2023.