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

NCT ID: NCT04746781

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

818 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-17

Study Completion Date

2022-12-15

Brief Summary

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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

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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

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Diabetes Mellitus, Type 2 PreDiabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Risk notification/education

Intervention Type BEHAVIORAL

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

Mobile 360° Video intervention arm

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.

Group Type EXPERIMENTAL

Mobile 360° Video intervention

Intervention Type BEHAVIORAL

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

Risk notification/education

Intervention Type BEHAVIORAL

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

Motivation and Problem Solving (MAPS) arm

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.

Group Type EXPERIMENTAL

Motivation and Problem Solving (MAPS)

Intervention Type BEHAVIORAL

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

Risk notification/education

Intervention Type BEHAVIORAL

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

Interventions

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Mobile 360° Video intervention

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

Intervention Type BEHAVIORAL

Motivation and Problem Solving (MAPS)

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

Intervention Type BEHAVIORAL

Risk notification/education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Bryan Smith Gibson

Assistant Professor Biomedical Informatics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39305089 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34125075 (View on PubMed)

Other Identifiers

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00132307

Identifier Type: -

Identifier Source: org_study_id

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