NCT03403231

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 10, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

February 1, 2018

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
9 months until next milestone

Results Posted

Study results publicly available

June 16, 2021

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

January 10, 2018

Results QC Date

March 24, 2021

Last Update Submit

July 19, 2023

Conditions

Keywords

VeteransType 2 diabetes mellitusPrediabetesSecure MessagingHealth PromotionPrevention and ControlMotivation

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 COMPARATOR

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

Behavioral: INVENT Secure Messaging Intervention

Arm 2: Urgency frame message strategy

EXPERIMENTAL

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

Arm 3: Social norm message strategy

EXPERIMENTAL

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

Arm 4: Urgency frame and social norm strategies

EXPERIMENTAL

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

Arm 5: Implementation Intentions and Urgency Frame

EXPERIMENTAL

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

Arm 6: Implementation Intentions and Social Norm

EXPERIMENTAL

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

Arm 7: Implementation Intentions, Urgency Frame & Social Norm

EXPERIMENTAL

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

Arm 8: Implementation Intentions

EXPERIMENTAL

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

Arm 9: Preference Checklists and Urgency Frame

EXPERIMENTAL

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

Arm 10: Preference Checklists and Social Norms

EXPERIMENTAL

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

Arm 11: Preference Checklists, Urgency Frame & Social Norm

EXPERIMENTAL

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

Arm 12: Preference Checklists

EXPERIMENTAL

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

Arm 13: Tailored Aspirations and Urgency Frame

EXPERIMENTAL

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

Arm 14: Tailored Aspirations and Social Norm

EXPERIMENTAL

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

Arm 15: Tailored Aspirations, Urgency Frame & Social Norm

EXPERIMENTAL

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

Arm 16: Tailored Aspirations

EXPERIMENTAL

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

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.

Arm 10: Preference Checklists and Social NormsArm 11: Preference Checklists, Urgency Frame & Social NormArm 12: Preference ChecklistsArm 13: Tailored Aspirations and Urgency FrameArm 14: Tailored Aspirations and Social NormArm 15: Tailored Aspirations, Urgency Frame & Social NormArm 16: Tailored AspirationsArm 1: Stock messages onlyArm 2: Urgency frame message strategyArm 3: Social norm message strategyArm 4: Urgency frame and social norm strategiesArm 5: Implementation Intentions and Urgency FrameArm 6: Implementation Intentions and Social NormArm 7: Implementation Intentions, Urgency Frame & Social NormArm 8: Implementation IntentionsArm 9: Preference Checklists and Urgency Frame

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Bradley Youles, Project Manager
Organization
VA Center for Clinical Management Research

Study Officials

  • Jeffrey T. Kullgren, MD MPH MS

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

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
Model Details: The investigators will use a factorial design to test the main effects and a limited number of interaction effects of 5 messaging strategies.
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

Locations