Clinical trial NCT03403231: INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT)
Official title: INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT) (CDA 13-267)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetes
Keywords: Veterans
Type 2 diabetes mellitus
Prediabetes
Secure Messaging
Health Promotion
Prevention and Control
Motivation
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-01-18
Enrollment: 144
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: The investigators will use a factorial design to test the main effects and a limited number of interaction effects of 5 messaging strategies.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

   * Diabetes
   * Dementia
   * Major functional limitations
   * Cirrhosis
   * Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage 4 chronic obstructive pulmonary disease (COPD)
   * End stage renal disease (ESRD)
   * New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)

Primary outcomes:
measure: Engagement in Recommended Behaviors to Prevent Type 2 Diabetes
timeFrame: 3 months
Secondary outcomes:
measure: Motivation to Prevent Type 2 Diabetes
timeFrame: 3 months
measure: Importance of Preventing Type 2 Diabetes
timeFrame: 3 months
measure: Use of Medication for T2DM Prevention
timeFrame: 3 months
measure: Perception for Risk for T2DM
timeFrame: 3 months
measure: Knowledge of Strategies to Prevent T2DM
timeFrame: 3 months
measure: Participation in Weight-related Wellness Programs
timeFrame: 3 months
measure: Weight Loss Behaviors
timeFrame: 3 months
measure: Physical Activity
timeFrame: 3 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: VA Ann Arbor Healthcare System, Ann Arbor, MI
state: Michigan
Study officials:
affiliation: VA Ann Arbor Healthcare System, Ann Arbor, MI
name: Jeffrey T. Kullgren, MD MPH MS
role: PRINCIPAL_INVESTIGATOR
References: