- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05583877
DM-BOOST Para Latinx: a Diabetes Mellitus Program Using Behavioral Economics to Optimize Outreach and Self-management Support With Technology for Latinx Patients
February 27, 2026 updated by: Daniel Amante
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Worcester, Massachusetts, United States, 01655
- University of Massachusetts Medical School
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Worcester, Massachusetts, United States, 01605
- UMass Memorial Health
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Aims 1 and 2 Patient Inclusion Criteria:
- Age > 18 years
- Diagnosis of type 2 diabetes
- Identifies as Hispanic/Latinx
- Spanish language preference
Aims 1 and 2 Patient Exclusion Criteria:
- Cognitive impairment
- Current prisoner
- Pregnant women
Aim 3 Patient Inclusion Criteria:
- Age > 18 years
- Diagnosis of type 2 diabetes
- Identifies as Hispanic/Latinx
- Spanish language preference
Aim 3 Patient Exclusion Criteria:
- Cognitive impairment
- Current prisoner
- Pregnant women
- Completed DSMT in previous year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Participants will receive supportive care using technology for DSMT in addition to usual care.
|
|
Active Comparator: 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.
|
Participants will receive usual care for DSMT.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Process Evaluation
Time Frame: 3 - 6 months
|
Evaluate engagement by examining the number of DSMT appointments scheduled, cancellation/no show rates and total number of DSMT-related encounters completed.
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3 - 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diabetes self-efficacy
Time Frame: 3 months
|
Diabetes self efficacy will be measured at baseline and 3 months after enrolling in the study using the Diabetes Management Self-Efficacy Scale.
Participants will provide feedback on set of questions, using a 5-point Likert scale( with 1=Strong Disagree, 2=Somewhat Disagree, 3= Neutral, 4=Somewhat Agree, 5= Strongly Agree)
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3 months
|
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Diabetes treatment satisfaction
Time Frame: 3 months
|
Diabetes Treatment Satisfaction will be measured at 3 months after enrolling in the study using the Diabetes Treatment Satisfaction Questionnaire Change tool.
Participants will be asked to share how their experience of current treatment has changed from their experience of treatment before the study began.
They will answer each question by choosing 3 for Much More Satisfied Now up to -3 for Much Less Satisfied Now.
(3,2,1,0,-1,-2,-3)
|
3 months
|
|
Change in HbA1c Percentage
Time Frame: 6 months
|
Measurement of HbA1c values to determine impact of intervention.
HbA1c values at baseline visit will be compared with values at 3-6 months after participant's enrollment.
These data will be obtained through EHR chart review.
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel J Amante, PhD, MPH, UMass Chan Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2025
Primary Completion (Actual)
October 31, 2025
Study Completion (Actual)
October 31, 2025
Study Registration Dates
First Submitted
October 13, 2022
First Submitted That Met QC Criteria
October 13, 2022
First Posted (Actual)
October 18, 2022
Study Record Updates
Last Update Posted (Actual)
March 3, 2026
Last Update Submitted That Met QC Criteria
February 27, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000376
- 1K01DK131318 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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