INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT) (INVENT)

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

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.

Study Overview

• Status: Completed
• Conditions: Prediabetes
• Intervention / Treatment: Behavioral: INVENT Secure Messaging Intervention

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
• Enrollment (Actual): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105-2303
      • VA Ann Arbor Healthcare System, Ann Arbor, MI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

16

Arms and Interventions

Participant Group / 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 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation to Prevent Type 2 Diabetes	The investigators will use survey data to evaluate mean change in motivation level to prevent diabetes between baseline and 3-months. The Treatment Self-Regulation Questionnaire (TSRQ) was included in the survey and respondents were asked about their level of motivation from 1 (Not at all motivated) to 10 (Highly motivated).	3 months
Importance of Preventing Type 2 Diabetes	The investigators will use survey data to evaluate mean changes in level of importance of preventing diabetes from baseline to 3 months. The Treatment Self-Regulation Questionnaire (TSRQ) was included in the survey and respondents were asked about their level of perceived importance from 1 (Not at all important) to 10 (Extremely important).	3 months
Use of Medication for T2DM Prevention	The investigators will use medical record data and survey data to evaluate whether participants began the use of medication for T2DM prevention from baseline to 3 months.	3 months
Perception for Risk for T2DM	The investigators will use survey data to evaluate mean changes in perception of risk for T2DM from baseline to 3 months. The Adriaanse T2DM Risk Perception Scale, which was included in the survey, measured self-assessed risk perception from 0 denoting no choice of developing T2DM to 100 denoting absolute confidence in developing T2DM	3 months
Knowledge of Strategies to Prevent T2DM	The investigators will use survey data to evaluate changes in knowledge of strategies to prevent Type 2 Diabetes between baseline and 3-month assessment. Respondents were given 3 open-ended questions to report things they could do to prevent diabetes. Each respective response to the 3 questions were coded and scored according to whether they indicated engagement in the following activities: weight loss, physical activity, use of metformin, or enrollment into a diabetes prevention program. Each question denoted with a positive response were coded with 1 whereas those that did not were coded as a 0. The three questions were summed into a final score ranging from 0 (no report of engagement in the aforementioned healthy activities) with the worst outcome to 3 (a report of 3 of the 4 aforementioned healthy activities) with the best outcome. The final scores were generated based on the mean difference between baseline and 3-month scores.	3 months
Participation in Weight-related Wellness Programs	The investigators will use survey data to evaluate how many participants enrolled in weight-related wellness programs from baseline to 3 months.	3 months
Weight Loss Behaviors	The investigators will use survey data to evaluate changes in weight loss behaviors at the 3-month post intervention assessment.	3 months
Physical Activity	The investigators will use survey data to evaluate changes in physical activity after the 3-month post intervention assessment. The International Physical Activity Questionnaire - Short Form (IPAQ-SF) was used to measure physical activity change. Respondents were asked to report how many hours and minutes within the past week they completed of vigorous physical activity, moderate physical activity, and brisk walking. The total sum of minutes for these three questions were subsequently coded into a yes/no binary variable for whether respondents met a recommended 150 minutes of overall physical activity within 7 days of being assessed. The values provided reflect a proportion of respondents that met or exceeded the 150 minute threshold of overall physical activity based on the newly generated variable that combined total minutes of vigorous physical activity, moderate physical activity, and brisk walking.	3 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jeffrey T. Kullgren, MD MPH MS, VA Ann Arbor Healthcare System, Ann Arbor, MI

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2018
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: January 10, 2018
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Prediabetes; Veterans; Motivation; Health Promotion; Type 2 diabetes mellitus; Prevention and Control; Secure Messaging
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: CDX 15-002; CDA 13-267 (Other Grant/Funding Number: HSR&D)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No