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INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT)

VA Office of Research and Development logo

VA Office of Research and Development

Status

Completed

Conditions

Prediabetes

Treatments

Behavioral: INVENT Secure Messaging Intervention

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT03403231
CDX 15-002
CDA 13-267 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment

144 patients

Sex

All

Ages

Under 75 years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

144 participants in 16 patient groups

Arm 1: Stock messages only
Active Comparator group
Description:
Participants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 2: Urgency frame message strategy
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame message strategy.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 3: Social norm message strategy
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the social norm messaging strategy.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 4: Urgency frame and social norm strategies
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the urgency frame and social norm messaging strategies.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 5: Implementation Intentions and Urgency Frame
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and urgency frame messaging strategies.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 6: Implementation Intentions and Social Norm
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the implementation intentions and social norm messaging strategies.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 7: Implementation Intentions, Urgency Frame & Social Norm
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions, urgency frame, and social norm messaging strategies.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 8: Implementation Intentions
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 9: Preference Checklists and Urgency Frame
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and urgency frame messaging strategies.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 10: Preference Checklists and Social Norms
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the preference checklists and social norm messaging strategies.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 11: Preference Checklists, Urgency Frame & Social Norm
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists, urgency frame, and social norm messaging strategies.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 12: Preference Checklists
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 13: Tailored Aspirations and Urgency Frame
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and urgency frame messaging strategies.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 14: Tailored Aspirations and Social Norm
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with both the tailored aspirations and social norm messaging strategies.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 15: Tailored Aspirations, Urgency Frame & Social Norm
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations, urgency frame, and social norm messaging strategies.
Treatment:
Behavioral: INVENT Secure Messaging Intervention
Arm 16: Tailored Aspirations
Experimental group
Description:
Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy.
Treatment:
Behavioral: INVENT Secure Messaging Intervention

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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