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Behavioural Intervention
Diabetes BOOST Program for Type 2 Diabetes
N/A
Waitlist Available
Led By Daniel J Amante, PhD, MPH
Research Sponsored by Daniel Amante
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age > 18 years
Diagnosis of type 2 diabetes
Must not have
Cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 - 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to develop a culturally-appropriate diabetes self-management program for Latinx patients, tested in collaboration with clinical, community and patient partners.
Who is the study for?
This trial is for Hispanic/Latinx adults over 18 with type 2 diabetes who prefer to speak Spanish and have completed a diabetes self-management training in the past year. It's not suitable for those with cognitive impairments, pregnant women, or current prisoners.
What is being tested?
The study is testing 'DM-BOOST para Latinx,' an adapted version of the DM-BOOST program designed to help Latinx patients manage their diabetes using behavioral economics and technology. The effectiveness will be assessed through community-based participatory research.
What are the potential side effects?
Since this intervention involves educational and support programs rather than medications, traditional side effects are not expected. However, participants may experience stress or discomfort related to lifestyle changes encouraged by the program.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have been diagnosed with type 2 diabetes.
Select...
I completed a diabetes self-management training last year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have difficulty with memory or thinking clearly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 - 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 - 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Process Evaluation
Secondary study objectives
Change in HbA1c Percentage
Diabetes self-efficacy
Diabetes treatment satisfaction
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention - Diabetes BOOSTExperimental Treatment1 Intervention
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 II: Usual CareActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diabetes BOOST
2021
N/A
~70
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Who is running the clinical trial?
Daniel AmanteLead Sponsor
1 Previous Clinical Trials
66 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,762 Total Patients Enrolled
Daniel J Amante, PhD, MPHPrincipal InvestigatorUMass Chan Medical School
1 Previous Clinical Trials
66 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am older than 18 years.I have been diagnosed with type 2 diabetes.I completed a diabetes self-management training last year.I prefer to communicate in Spanish.I have difficulty with memory or thinking clearly.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention - Diabetes BOOST
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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