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Clinical Trials/NCT03403231
NCT03403231
Completed
Not Applicable

INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT) (CDA 13-267)

VA Office of Research and Development1 site in 1 country144 target enrollmentFebruary 1, 2018
ConditionsPrediabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prediabetes
Sponsor
VA Office of Research and Development
Enrollment
144
Locations
1
Primary Endpoint
Engagement in Recommended Behaviors to Prevent Type 2 Diabetes
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

This study will evaluate a VA MyHealtheVet Secure Messaging intervention that uses different intervention messaging strategies designed to increase engagement in behaviors to prevent type 2 diabetes.

The investigators will enroll 144 eligible Veterans into a 12-week MyHealtheVet Secure Messaging intervention. Eligible Veterans include those who are currently using MyHealtheVet secure messaging, meet inclusion/exclusion criteria, and have received an HbA1c test within the last 6 months that meets the ADA/CDC classification for prediabetes. Study participants will be surveyed about their engagement in behaviors to prevent TDM2 and mediators of this engagement. After completing a baseline survey, participants will be randomly assigned to receive different novel presentations of information about ways to prevent T2DM through both Secure Messaging and US Mail. The investigators will test the 5 presentations that each: (1) represent an innovative approach from behavioral economics or health psychology with great promise to increase engagement in behaviors to prevent T2DM among patients with prediabetes; and (2) have not been tested in this setting.

Detailed Description

There is tremendous national enthusiasm for translating and disseminating efficacious strategies to prevent type 2 diabetes mellitus (T2DM). Yet, little attention has been devoted to how the investigators can better leverage the processes through which patients receive information about prevention of T2DM to better engage them in such prevention. Further, despite efforts to disseminate structured programs, many patients at high risk for developing T2DM may still be unable or unwilling to access them. In these cases, increasing patient engagement in individually directed lifestyle change or pharmacotherapy is critical. Strategies developed in the fields of behavioral economics and health psychology hold significant promise for improving Veteran engagement in each of these approaches. To date, however, these strategies have rarely been translated into real-world settings where they could benefit Veterans. This novel work will address this critical gap and could transform communication with Veterans about prevention in ways that will improve their health outcomes. The following 5 strategies will be implemented in the weekly messages that study participants will receive: (1) tailoring to aspirations in life; (2) implementation intentions; (3) preference checklists; (4) urgency framing; (5) social norms. The investigators will implement these strategies alone and in combination in a 16-arm factorial design experiment.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
September 30, 2020
Last Updated
2 years ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • HbA1c test within the past 6 months that meets the ADA/CDC requirements for prediabetes.
  • Currently registered in the VA's MyHealtheVet Secure Messaging System
  • Receiving care within the Ann Arbor VA Healthcare System

Exclusion Criteria

  • Completed more than 4 VA MOVE! classes in the last year (or other evidence of another recent weight loss program)
  • Are trying to lose weight and are very physically active
  • Are \>75 years of age
  • Are pregnant or plan to be
  • Are taking Metformin
  • Have participated in the FINDIT study (this study's predecessor under the same grant funding)
  • Have been hospitalized or received rehab for stroke or myocardial infarction within past 6 months
  • Have received chemotherapy for cancer in the past 6 months
  • Self-report or have any International Classification of Diseases (ICD-9/10) codes for:
  • Major functional limitations

Outcomes

Primary Outcomes

Engagement in Recommended Behaviors to Prevent Type 2 Diabetes

Time Frame: 3 months

The investigators will use survey and medical record data to evaluate changes in participants' engagement in recommended behaviors to prevent type 2 diabetes.

Secondary Outcomes

  • Weight Loss Behaviors(3 months)
  • Perception for Risk for T2DM(3 months)
  • Motivation to Prevent Type 2 Diabetes(3 months)
  • Use of Medication for T2DM Prevention(3 months)
  • Knowledge of Strategies to Prevent T2DM(3 months)
  • Importance of Preventing Type 2 Diabetes(3 months)
  • Participation in Weight-related Wellness Programs(3 months)
  • Physical Activity(3 months)

Study Sites (1)

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