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

NCT04746781 | Completed

• 1 other identifier: 00132307
• Study Type: interventional
• Target: 818
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus, Type 2; PreDiabetes

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Changes in self-efficacy

  1 month

• Changes in Risk perceptions

  1 month

Study Arms (3)

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

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.

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.

Behavioral: Motivation and Problem Solving (MAPS); Behavioral: Risk notification/education

Interventions

Mobile 360° Video intervention BEHAVIORAL

Using 360° Videos to educate participants about the effect of diabetes.

Mobile 360° Video intervention arm

Motivation and Problem Solving (MAPS) BEHAVIORAL

Using Motivation and Problem Solving to help people enroll in the Diabetes Prevention Program.

Motivation and Problem Solving (MAPS) arm

Risk notification/education BEHAVIORAL

Sending participants (all of whom meet the diagnostic criteria for prediabetes) educational information about the condition.

Mobile 360° Video intervention arm; Motivation and Problem Solving (MAPS) arm; Risk notification/education arm

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead
• Centers for Disease Control and Prevention: collaborator

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Related Publications (2)

• 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.

  PMID: 39305089 DERIVED

• 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.

  PMID: 34125075 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Biomedical Informatics

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 10, 2021
• Study Start: February 17, 2021
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: May 22, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)