INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT)

ID: NCT03403231

Status: Recruiting

Phase: N/A

Start Date: February 01, 2018

First Submitted: January 10, 2018

Last Updated: February 23, 2018

Results: N/A

Organization: VA Office of Research and Development

Sponsors & Collaborators: VA Office of Research and Development

Location: United States

Conditions: Prediabetes

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Study Details
No Results Posted

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Prediabetes	Behavioral: INVENT Secure Messaging Intervention Other Names	N/A

Tracking Information

First Submitted Date	January 10, 2018
Last Update Posted Date	February 23, 2018
Actual Start Date	February 01, 2018
Anticipated Completion Date	January 29, 2020
Actual Primary Completion Date	January 29, 2019
Results First Submitted Date	N/A
Received Results Disposit Date	N/A

Current Primary Outcome Measures

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.

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Motivation to prevent type 2 diabetes [Time Frame: 3 months]
The investigators will use survey data to evaluate changes in level of motivation to prevent diabetes from baseline to 3 months.
Importance of preventing type 2 diabetes [Time Frame: 3 months]
The investigators will use survey data to evaluate changes in level of importance of preventing diabetes from baseline to 3 months.
Use of medication for T2DM prevention [Time Frame: 3 months]
The investigators will use medical record data and survey data to evaluate changes in use of medication for T2DM prevention from baseline to 3 months.
Perception for risk for T2DM [Time Frame: 3 months]
The investigators will use survey data to evaluate changes in perception of risk for T2DM from baseline to 3 months.
Knowledge of strategies to prevent T2DM [Time Frame: 3 months]
The investigators will use survey data to evaluate changes in knowledge of strategies to prevent T2DM from baseline to 3 months.
Participation in weight-related wellness programs [Time Frame: 3 months]
The investigators will use survey data to evaluate changes in participation in weight-related wellness programs from baseline to 3 months.
Weight loss behaviors [Time Frame: 3 months]
The investigators will use survey data to evaluate changes in weight loss behaviors from baseline to 3 months.
Physical activity [Time Frame: 3 months]
The investigators will use survey data to evaluate changes in physical activity from baseline to 3 months.

Original Secondary Outcome Measures

Not Available

Study Design

Brief Title	INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT)
Official Title	INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT) (CDA 13-267-2)
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.
Study Type	Interventional
Study Phase	N/A
Estimated Enrollment	144
Allocation	Randomized
Interventional Model	Factorial Assignment
Masking	Single
Primary Purpose	Prevention
Conditions	Prediabetes
Target Follow-Up Duration	N/A
Biospecimen:	N/A
Sampling Method	N/A
Study Population	N/A
Intervention	Behavioral: INVENT Secure Messaging Intervention 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. Other Names
Study Groups/Cohorts	Arm 1: Stock messages only Participants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes. Arm 2: Urgency frame message strategy Participants 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 Participants 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 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. Arm 5: Implementation Intentions and Urgency Frame 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. Arm 6: Implementation Intentions and Social Norm 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. Arm 7: Implementation Intentions, Urgency Frame & Social Norm 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. Arm 8: Implementation Intentions Participants 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 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. Arm 10: Preference Checklists and Social Norms 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. Arm 11: Preference Checklists, Urgency Frame & Social Norm 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. Arm 12: Preference Checklists Participants 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 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. Arm 14: Tailored Aspirations and Social Norm 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. Arm 15: Tailored Aspirations, Urgency Frame & Social Norm 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. Arm 16: Tailored Aspirations Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy.
Study Arms	Active Comparator Arm 1: Stock messages only Participants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 10: Preference Checklists and Social Norms 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. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 11: Preference Checklists, Urgency Frame & Social Norm 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. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 12: Preference Checklists Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 13: Tailored Aspirations and Urgency Frame 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. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 14: Tailored Aspirations and Social Norm 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. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 15: Tailored Aspirations, Urgency Frame & Social Norm 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. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 16: Tailored Aspirations Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 2: Urgency frame message strategy Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame message strategy. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 3: Social norm message strategy Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the social norm messaging strategy. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 4: Urgency frame and social norm strategies 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. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 5: Implementation Intentions and Urgency Frame 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. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 6: Implementation Intentions and Social Norm 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. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 7: Implementation Intentions, Urgency Frame & Social Norm 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. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 8: Implementation Intentions Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy. Behavioral : INVENT Secure Messaging Intervention 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. Experimental Arm 9: Preference Checklists and Urgency Frame 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. Behavioral : INVENT Secure Messaging Intervention 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.

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

Recruitment Information

Recruitment Status:	Recruiting
Enrollment	144
Completion Date	January 29, 2020
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)
Gender	All
Age	N/A to 75 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Bradley Youles, MPA (734) 845-5055 [email protected] Jeffrey T Kullgren, MD MPH MS (734) 845-5290 [email protected]
Listed Location Countries	United States

Administrative Information

NCT Number:	NCT03403231
Other Study ID Numbers	CDX 15-002 CDA 13-267
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement	Not Available
Responsible Party	,
Study Sponsor	VA Office of Research and Development
Collaborators	Not Available
Investigators	Principal Investigator Jeffrey T. Kullgren, MD MPH MS VA Ann Arbor Healthcare System, Ann Arbor, MI