The Effect of 360 Video and MAPS on Enrollment in the DPP

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

The Effect of Mobile Immersive Video and Motivation and Problem Solving on Enrollment in the Diabetes Prevention Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04746781
• Other study ID #: 00132307
• Status: Completed
• Phase: N/A
• Start date: February 17, 2021
• Est. completion date: December 15, 2022

Study information

• Verified date: May 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 818
• Est. completion date: December 15, 2022
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• PreDiabetes

Intervention

Behavioral:
• Mobile 360° Video intervention
Using 360° Videos to educate participants about the effect of diabetes.
• Motivation and Problem Solving (MAPS)
Using Motivation and Problem Solving to help people enroll in the Diabetes Prevention Program.
• Risk notification/education
Sending participants (all of whom meet the diagnostic criteria for prediabetes) educational information about the condition.

Locations

Country	Name	City	State
United States	University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-month
Primary	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.	1 month
Secondary	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	1 month
Secondary	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	1 month