INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT)
INVENT
2 other identifiers
interventional
144
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2018
CompletedFirst Posted
Study publicly available on registry
January 18, 2018
CompletedStudy Start
First participant enrolled
February 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedResults Posted
Study results publicly available
June 16, 2021
CompletedJuly 25, 2023
July 1, 2023
2.1 years
January 10, 2018
March 24, 2021
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Engagement in Recommended Behaviors to Prevent Type 2 Diabetes
The investigators will use survey and medical record data to evaluate changes in participants' engagement in recommended behaviors to prevent type 2 diabetes.
3 months
Secondary Outcomes (8)
Motivation to Prevent Type 2 Diabetes
3 months
Importance of Preventing Type 2 Diabetes
3 months
Use of Medication for T2DM Prevention
3 months
Perception for Risk for T2DM
3 months
Knowledge of Strategies to Prevent T2DM
3 months
- +3 more secondary outcomes
Study Arms (16)
Arm 1: Stock messages only
ACTIVE COMPARATORParticipants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes.
Arm 2: Urgency frame message strategy
EXPERIMENTALParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame message strategy.
Arm 3: Social norm message strategy
EXPERIMENTALParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the social norm messaging strategy.
Arm 4: Urgency frame and social norm strategies
EXPERIMENTALParticipants 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.
Arm 5: Implementation Intentions and Urgency Frame
EXPERIMENTALParticipants 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.
Arm 6: Implementation Intentions and Social Norm
EXPERIMENTALParticipants 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.
Arm 7: Implementation Intentions, Urgency Frame & Social Norm
EXPERIMENTALParticipants 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.
Arm 8: Implementation Intentions
EXPERIMENTALParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy.
Arm 9: Preference Checklists and Urgency Frame
EXPERIMENTALParticipants 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.
Arm 10: Preference Checklists and Social Norms
EXPERIMENTALParticipants 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.
Arm 11: Preference Checklists, Urgency Frame & Social Norm
EXPERIMENTALParticipants 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.
Arm 12: Preference Checklists
EXPERIMENTALParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy.
Arm 13: Tailored Aspirations and Urgency Frame
EXPERIMENTALParticipants 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.
Arm 14: Tailored Aspirations and Social Norm
EXPERIMENTALParticipants 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.
Arm 15: Tailored Aspirations, Urgency Frame & Social Norm
EXPERIMENTALParticipants 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.
Arm 16: Tailored Aspirations
EXPERIMENTALParticipants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy.
Interventions
We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105-2303, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bradley Youles, Project Manager
- Organization
- VA Center for Clinical Management Research
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey T. Kullgren, MD MPH MS
VA Ann Arbor Healthcare System, Ann Arbor, MI
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2018
First Posted
January 18, 2018
Study Start
February 1, 2018
Primary Completion
March 1, 2020
Study Completion
September 30, 2020
Last Updated
July 25, 2023
Results First Posted
June 16, 2021
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share