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

NCT ID: NCT05583877

Last Updated: 2025-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-12-01

Study Completion Date

2026-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators
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.

Study Groups

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Intervention - Diabetes BOOST

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.

Group Type EXPERIMENTAL

Diabetes BOOST

Intervention Type BEHAVIORAL

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

Usual Care

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Participants will receive usual care for DSMT.

Interventions

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Diabetes BOOST

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

Intervention Type BEHAVIORAL

Usual Care

Participants will receive usual care for DSMT.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

* Cognitive impairment
* Current prisoner
* Pregnant women


* Cognitive impairment
* Current prisoner
* Pregnant women
* Completed DSMT in previous year
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Daniel Amante

OTHER

Sponsor Role lead

Responsible Party

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Daniel Amante

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Daniel J Amante, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

UMass Chan Medical School

Locations

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UMass Memorial health

Worcester, Massachusetts, United States

Site Status RECRUITING

University of Massachusetts Medical School

Worcester, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Countries

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United States

Central Contacts

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Daniel J Amante, PhD, MPH

Role: CONTACT

508-856-8480

Facility Contacts

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Daniel Amante, PhD, MPH

Role: primary

5088568480

Daniel Amante, PhD, MPH

Role: primary

774-418-3645

Other Identifiers

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1K01DK131318

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00000376

Identifier Type: -

Identifier Source: org_study_id

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