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

Primary Purpose

Prediabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

INVENT Secure Messaging Intervention

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring Veterans, Type 2 diabetes mellitus, Prediabetes, Secure Messaging, Health Promotion, Prevention and Control, Motivation

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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)
- New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)

Sites / Locations

VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Active Comparator

Experimental

Arm Label

Arm 1: Stock messages only

Arm 2: Urgency frame message strategy

Arm 3: Social norm message strategy

Arm 4: Urgency frame and social norm strategies

Arm 5: Implementation Intentions and Urgency Frame

Arm 6: Implementation Intentions and Social Norm

Arm 7: Implementation Intentions, Urgency Frame & Social Norm

Arm 8: Implementation Intentions

Arm 9: Preference Checklists and Urgency Frame

Arm 10: Preference Checklists and Social Norms

Arm 11: Preference Checklists, Urgency Frame & Social Norm

Arm 12: Preference Checklists

Arm 13: Tailored Aspirations and Urgency Frame

Arm 14: Tailored Aspirations and Social Norm

Arm 15: Tailored Aspirations, Urgency Frame & Social Norm

Arm 16: Tailored Aspirations

Arm Description

Participants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes.

Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame 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.

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.

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.

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.

Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy.

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.

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.

Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy.

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.

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.

Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

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).

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.

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

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.

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.

Weight Loss Behaviors

The investigators will use survey data to evaluate changes in weight loss behaviors at the 3-month post intervention assessment.

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.

Full Information

NCT ID

NCT03403231

First Posted

January 10, 2018

Last Updated

July 19, 2023

Sponsor

VA Office of Research and Development

1. Study Identification

Unique Protocol Identification Number

NCT03403231

Brief Title

INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT)

Acronym

INVENT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2018 (Actual)

Primary Completion Date

March 1, 2020 (Actual)

Study Completion Date

September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetes

Keywords

Veterans, Type 2 diabetes mellitus, Prediabetes, Secure Messaging, Health Promotion, Prevention and Control, Motivation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

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.

Masking

Investigator

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1: Stock messages only

Arm Type

Active Comparator

Arm Description

Participants will only receive the stock messages that encourage following recommended behaviors for reducing the risk for developing diabetes.

Arm Title

Arm 2: Urgency frame message strategy

Arm Type

Experimental

Arm Description

Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the urgency frame message strategy.

Arm Title

Arm 3: Social norm message strategy

Arm Type

Experimental

Arm Description

Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the social norm messaging strategy.

Arm Title

Arm 4: Urgency frame and social norm strategies

Arm Type

Experimental

Arm Description

Arm Title

Arm 5: Implementation Intentions and Urgency Frame

Arm Type

Experimental

Arm Description

Arm Title

Arm 6: Implementation Intentions and Social Norm

Arm Type

Experimental

Arm Description

Arm Title

Arm 7: Implementation Intentions, Urgency Frame & Social Norm

Arm Type

Experimental

Arm Description

Arm Title

Arm 8: Implementation Intentions

Arm Type

Experimental

Arm Description

Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the implementation intentions messaging strategy.

Arm Title

Arm 9: Preference Checklists and Urgency Frame

Arm Type

Experimental

Arm Description

Arm Title

Arm 10: Preference Checklists and Social Norms

Arm Type

Experimental

Arm Description

Arm Title

Arm 11: Preference Checklists, Urgency Frame & Social Norm

Arm Type

Experimental

Arm Description

Arm Title

Arm 12: Preference Checklists

Arm Type

Experimental

Arm Description

Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the preference checklists messaging strategy.

Arm Title

Arm 13: Tailored Aspirations and Urgency Frame

Arm Type

Experimental

Arm Description

Arm Title

Arm 14: Tailored Aspirations and Social Norm

Arm Type

Experimental

Arm Description

Arm Title

Arm 15: Tailored Aspirations, Urgency Frame & Social Norm

Arm Type

Experimental

Arm Description

Arm Title

Arm 16: Tailored Aspirations

Arm Type

Experimental

Arm Description

Participants will receive messages that encourage following recommended behaviors for reducing the risk for developing diabetes integrated with the tailored aspirations messaging strategy.

Intervention Type

Behavioral

Intervention Name(s)

INVENT Secure Messaging Intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Engagement in Recommended Behaviors to Prevent Type 2 Diabetes

Description

The investigators will use survey and medical record data to evaluate changes in participants' engagement in recommended behaviors to prevent type 2 diabetes.

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Motivation to Prevent Type 2 Diabetes

Description

Time Frame

3 months

Title

Importance of Preventing Type 2 Diabetes

Description

Time Frame

3 months

Title

Use of Medication for T2DM Prevention

Description

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.

Time Frame

3 months

Title

Perception for Risk for T2DM

Description

Time Frame

3 months

Title

Knowledge of Strategies to Prevent T2DM

Description

Time Frame

3 months

Title

Participation in Weight-related Wellness Programs

Description

The investigators will use survey data to evaluate how many participants enrolled in weight-related wellness programs from baseline to 3 months.

Time Frame

3 months

Title

Weight Loss Behaviors

Description

The investigators will use survey data to evaluate changes in weight loss behaviors at the 3-month post intervention assessment.

Time Frame

3 months

Title

Physical Activity

Description

Time Frame

3 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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) New York Heart Association (NYHA) class III or IV congestive heart failure (CHF)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jeffrey T. Kullgren, MD MPH MS

Organizational Affiliation

VA Ann Arbor Healthcare System, Ann Arbor, MI

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Ann Arbor Healthcare System, Ann Arbor, MI

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48105-2303

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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