DM-BOOST Para Latinx: a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology for Latinx Patients

NCT05583877 | Completed

• 2 other identifiers: STUDY000003761K01DK131318
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The specific aims of this project are to culturally adapt the DM-BOOST intervention for Latinx patients, usability test 'DM-BOOST para Latinx' to optimize cultural appropriateness and patient engagement and conduct a feasibility evaluation of DM-BOOST para Latinx. These aims will be accomplished via a community-based participatory research approach in collaboration with clinical, community and patient partners. This project will inform subsequent proposals to evaluate implementation of DM-BOOST in the UMass Memorial Health Care system.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Process Evaluation

  Evaluate engagement by examining the number of DSMT appointments scheduled, cancellation/no show rates and total number of DSMT-related encounters completed.

  3 - 6 months

Secondary Outcomes (3)

• Diabetes self-efficacy

  3 months

• Diabetes treatment satisfaction

  3 months

• Change in HbA1c Percentage

  6 months

Study Arms (2)

Intervention - Diabetes BOOST

EXPERIMENTAL

Intervention group participants will complete a baseline survey, receive a referral to DSMT from the research team, a mailed welcome letter and self-care education sent via a series of personalized patient portal secure messages, text messages, and video call. They will be sent text messages with information about one of the American Association of Diabetes Educators 7 self-care behaviors and will receive encouragement to author their own self-management behavioral goals. Participants will also complete a telehealth training video call with research staff to review the functionality of their patient portal and refine diabetes-related goals. The participant will then be encouraged to send a patient portal message to their DSMT CDCES that includes their personalized goals prior to their scheduled DSMT session. They will then complete a 3-month follow-up survey and qualitative interview.

Behavioral: Diabetes BOOST

Usual Care

ACTIVE COMPARATOR

Comparison Group participants will complete a baseline survey, receive a DSMT referral request from research team to their primary care provider and a mailed welcome letter. The mailed letter will welcome the participant to the study and contain general information about diabetes self-care behaviors and goal setting. They will complete a DSMT session. They will then complete a 3-month follow-up survey and qualitative interview.

Behavioral: Usual Care

Interventions

Usual Care BEHAVIORAL

Participants will receive usual care for DSMT.

Usual Care

Diabetes BOOST BEHAVIORAL

Participants will receive supportive care using technology for DSMT in addition to usual care.

Intervention - Diabetes BOOST

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Diagnosis of type 2 diabetes
• Identifies as Hispanic/Latinx
• Spanish language preference

You may not qualify if:

• Cognitive impairment
• Current prisoner
• Pregnant women
• Age \> 18 years
• Diagnosis of type 2 diabetes
• Identifies as Hispanic/Latinx
• Spanish language preference
• Cognitive impairment
• Current prisoner
• Pregnant women
• Completed DSMT in previous year

Sponsors & Collaborators

• Daniel Amante: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (2)

UMass Memorial health

Worcester, Massachusetts, 01605, United States

Location

University of Massachusetts Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Daniel J Amante, PhD, MPH

  UMass Chan Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: After completing the informed consent, study staff will enter the participant's information into pre-populated REDCap identification numbers. This will assign allocation based on the randomization table. Using this technique, participants will be blinded to allocation. However, research staff will not be blinded to provide personalized training for intervention and control. The investigator will be blinded to randomization for all participants during the study.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The purpose of this study is to culturally-adapt a patient-centric intervention designed to improve implementation of diabetes self-management training in Spanish-speaking patients. To accomplish cultural adaptation of the DM-BOOST intervention, a Patient Research Expert Panel (PREP) (n\</=4) will participate in Community Engagement Studios to inform adaptations (Aim 1) and usability test the intervention (Aim 2). A randomized pilot with new patients (n\</=70) will then be conducted to assess feasibility (Aim 3).

Study Record Dates

• First Submitted: October 13, 2022
• First Posted: October 18, 2022
• Study Start: January 29, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)