100 Participants Needed

Text Messaging for Diabetes Control in Homeless Populations

Recruiting at 2 trial locations
LB
RA
Overseen ByRamin Asgary, MD, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: George Washington University
Approved in 1 JurisdictionThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

Is text messaging for diabetes control safe for homeless populations?

The studies reviewed focus on mindfulness interventions for diabetes management, which are generally considered safe. Participants in these studies reported positive outcomes like reduced stress and improved well-being, suggesting that similar interventions, such as text messaging for diabetes control, are likely safe.12345

How is the text messaging treatment for diabetes in homeless populations different from other treatments?

This treatment is unique because it uses text messaging to deliver mindfulness meditation and diabetes management support, making it accessible and feasible for homeless individuals who often have mobile phones but limited access to traditional healthcare. It focuses on improving communication, education, and behavior change through a digital platform, which is not commonly used in standard diabetes treatments.678910

What data supports the effectiveness of the treatment for diabetes control in homeless populations?

Research shows that mindfulness-based stress reduction (MBSR) can help improve emotional wellbeing and blood sugar control in people with type 2 diabetes. This suggests that similar mindfulness interventions, like the digital meditation intervention in the trial, might also be effective for managing diabetes in homeless populations.14111213

Are You a Good Fit for This Trial?

This trial is for homeless individuals over 21 with type 2 diabetes, who have a recent HbA1c level of at least 8%, and can communicate in English or Spanish. They must be connected to the shelter-clinics involved in the study and able to read/respond to texts. Those with severe uncontrolled illnesses, current severe substance abuse treatment, recent heart attack or stroke, or women who are pregnant/recently gave birth cannot participate.

Inclusion Criteria

Your most recent HbA1c level is 8% or higher.
Connected to study sites' shelter-clinics for care
I have been diagnosed with type 2 diabetes.
See 1 more

Exclusion Criteria

I have a severe illness that is not under control.
You cannot read or respond to text messages.
Inability to provide informed consent
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 months of DM management support via SMS texts including reminders for medication adherence, appointments, and DM self-care activities as well as education and support

6 months
Monthly virtual check-ins

Follow-up

Participants are monitored for changes in HbA1c and adherence to DM self-care activities, medications, and appointments

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Attention Control
  • Intervention
Trial Overview The study is testing whether a strategy using SMS text messages can help manage diabetes better among homeless people. It's a Randomized Controlled Trial (RCT), meaning participants will be randomly assigned to either receive these special texts (intervention) or standard care without extra texting (attention control).
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
The intervention (INT) will include 6 months of DM management support via SMS texts including reminders for medication adherence, appointments, and DM self-care activities as well as education, and support.
Group II: ControlPlacebo Group1 Intervention
The control (CL) will receive 6 months of texts for general health promotion.

Intervention is already approved in United States for the following indications:

🇺🇸
Approved in United States as Digital Meditation Intervention for:
  • Loneliness in Older Adults
  • Social Isolation
  • Emotional Well-being

Find a Clinic Near You

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials
263
Recruited
476,000+

NYU Langone Health

Collaborator

Trials
1,431
Recruited
838,000+

Published Research Related to This Trial

A mindfulness-based stress reduction (MBSR) intervention significantly reduced levels of depression and improved health status in patients with type 2 diabetes over the first year of a 5-year study, with effect sizes of 0.71 and 0.54, respectively.
While the MBSR group experienced notable reductions in psychosocial distress, there were no significant changes in albuminuria levels, indicating that the intervention may primarily benefit mental health rather than directly affecting kidney function.
Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetic patients: design and first results of a randomized controlled trial (the Heidelberger Diabetes and Stress-study).Hartmann, M., Kopf, S., Kircher, C., et al.[2022]
In a study of 399 participants with a median age of 47, those with higher dispositional mindfulness scores were 35% more likely to have normal plasma glucose levels, suggesting a positive association between mindfulness and glucose regulation.
The study found that mindfulness was not significantly linked to type 2 diabetes but indicated that mindfulness might help improve glucose regulation through lower obesity rates and a greater sense of control, highlighting potential benefits of mindfulness-based interventions.
Associations of Mindfulness with Glucose Regulation and Diabetes.Loucks, EB., Gilman, SE., Britton, WB., et al.[2019]
A low-dose mindfulness-based stress reduction (MBSR) intervention was successfully delivered to prediabetes and diabetes patients, showing feasibility in a clinical setting with a recruitment rate of 55.9% and an attrition rate of 26.3%.
Participants experienced significant improvements post-intervention, including a reduction in depression scores, increased engagement in flexibility exercises, and a decrease in glycosylated hemoglobin (HbA1c) levels, indicating potential benefits for both mental and physical health.
A feasibility study on low-dose mindfulness-based stress reduction intervention among prediabetes and diabetes patients.Xia, T., Lopes, S., Chen, L., et al.[2022]

Citations

Sustained effects of a mindfulness-based stress-reduction intervention in type 2 diabetic patients: design and first results of a randomized controlled trial (the Heidelberger Diabetes and Stress-study). [2022]
Associations of Mindfulness with Glucose Regulation and Diabetes. [2019]
A feasibility study on low-dose mindfulness-based stress reduction intervention among prediabetes and diabetes patients. [2022]
The Impact of Mindfulness-Based Stress Reduction on Emotional Wellbeing and Glycemic Control of Patients with Type 2 Diabetes Mellitus. [2022]
Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial. [2022]
Use of the Serenity Prayer among adults with type 2 diabetes: a pilot study. [2011]
Mindfulness-Based Stress Reduction in Women with Overweight or Obesity: A Randomized Clinical Trial. [2019]
A Mixed-Methods, Randomized Clinical Trial to Examine Feasibility of a Mindfulness-Based Stress Management and Diabetes Risk Reduction Intervention for African Americans with Prediabetes. [2020]
Perceptions, Attitudes, and Experience Regarding mHealth Among Homeless Persons in New York City Shelters. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Disparities in Text Messaging Interventions to Improve Diabetes Management in the United States. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Short messaging service (SMS) texting for uncontrolled diabetes among persons experiencing homelessness: Study protocol for a randomized trial. [2023]
Delivering Mindfulness-Based Interventions for Insomnia, Pain, and Dysfunctional Eating Through a Text Messaging App: Three Randomized Controlled Trials Investigating the Effectiveness and Mediating Mechanisms. [2022]
13.United Statespubmed.ncbi.nlm.nih.gov
Text Messaging in the Patient-Centered Medical Home to Improve Glucose Control and Retinopathy Screening. [2020]
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