Clinical trial NCT04746781: The Effect of 360 Video and MAPS on Enrollment in the DPP
Official title: The Effect of Mobile Immersive Video and Motivation and Problem Solving on Enrollment in the Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
PreDiabetes
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2021-02-10
Enrollment: 818
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Diabetes prevention program enrollment
timeFrame: 1-month
measure: 4 weeks of engagement in the Diabetes prevention program
timeFrame: 1 month
Secondary outcomes:
measure: Changes in self-efficacy
timeFrame: 1 month
measure: Changes in Risk perceptions
timeFrame: 1 month
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
References:
citation: Gibson 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.