INcreasing Veteran EngagemeNT to Prevent Diabetes (INVENT)

Prediabetes Clinical Trial

— INVENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03403231
• Other study ID #: CDX 15-002
• Secondary ID: CDA 13-267
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: September 30, 2020

Study information

• Verified date: July 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: September 30, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State

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.

Locations

Country	Name	City	State
United States	VA Ann Arbor Healthcare System, Ann Arbor, MI	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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