Text Messaging for Diabetes Control in Homeless Populations

Recruiting at 2 trial locations

Overseen By Ramin Asgary, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: George Washington University

Disqualifiers: Pregnancy, Severe illness, Heart attack, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{1 4 11 12 13}

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.

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

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?

Group I: Intervention Experimental Treatment 1 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: Control Placebo Group 1 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study involving 60 patients with type 2 diabetes, an 8-session mindfulness-based stress reduction (MBSR) program significantly improved emotional well-being and glycemic control, as evidenced by reductions in fasting blood sugar (FBS) and HbA1c levels.

The MBSR intervention also led to significant decreases in anxiety and depression scores compared to the control group, highlighting its potential as an effective complementary treatment for managing both emotional and physical health in diabetes patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of Mindfulness-Based Stress Reduction on Emotional Wellbeing and Glycemic Control of Patients with Type 2 Diabetes Mellitus. Armani Kian, A., Vahdani, B., Noorbala, AA., et al.[2022]

A mindfulness intervention integrated into diabetes self-management education significantly improved diabetes distress over time in veterans with diabetes, particularly for those with baseline HbA1C levels below 8.5%.

While both the mindfulness intervention and standard diabetes education improved diabetes self-efficacy, PTSD, depression, and HbA1C levels, the mindfulness approach showed stronger long-term benefits specifically for reducing diabetes distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial. DiNardo, MM., Greco, C., Phares, AD., et al.[2022]

A pilot study involving 36 participants explored the impact of daily recitation of the Serenity Prayer over 6 weeks on blood glucose levels in individuals with uncontrolled type 2 diabetes.

Results showed minimal effect, with only 2 participants experiencing lower blood glucose levels, while others had no change or an increase, highlighting the need for further research to assess the efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Serenity Prayer among adults with type 2 diabetes: a pilot study. Sacco, LM., Griffin, MT., McNulty, R., et al.[2011]

Mindfulness-based stress reduction (MBSR) significantly improved mindfulness and reduced perceived stress in women with overweight or obesity after 8 weeks, compared to a health education group.

MBSR also led to significant reductions in fasting glucose levels at both 8 and 16 weeks, suggesting potential cardiometabolic benefits, while no significant changes were observed in blood pressure or weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction in Women with Overweight or Obesity: A Randomized Clinical Trial. Raja-Khan, N., Agito, K., Shah, J., et al.[2019]

A study involving 68 African American adults with prediabetes showed that a mindfulness-based diabetes risk-reduction program was feasible, with high participant engagement and retention rates, indicating strong acceptability of the intervention.

Participants in the mindfulness program experienced significant reductions in perceived stress, body mass index (BMI), and unhealthy dietary intake, suggesting that this approach may effectively support lifestyle changes that reduce diabetes risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Woods-Giscombe, CL., Gaylord, SA., Li, Y., et al.[2020]

A study involving 50 homeless individuals in New York City revealed that most participants had mobile phones and were supportive of using text messaging for health care communication, such as appointment reminders and health education.

Participants preferred concise, positively framed text messages and believed that free cell phone plans could enhance their access to health care, suggesting that mobile health strategies could significantly improve health outcomes for the homeless population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions, Attitudes, and Experience Regarding mHealth Among Homeless Persons in New York City Shelters. Asgary, R., Sckell, B., Alcabes, A., et al.[2022]

Only 9 out of 792 studies on SMS interventions for type 2 diabetes management in the U.S. met the inclusion criteria, highlighting a significant gap in research on this topic.

While 63% of participants in these studies were non-white, there was a lack of cultural adaptations and comprehensive sociodemographic data, indicating a need for more inclusive and tailored interventions for diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disparities in Text Messaging Interventions to Improve Diabetes Management in the United States. Eyler, AA., Gachupin, FC., Johnston, SL., et al.[2022]

This study will evaluate the effectiveness of a 6-month SMS texting program for managing diabetes in 100 adults experiencing homelessness, measuring changes in HbA1c and adherence to self-care activities over 9 months.

The research will also gather insights from both patients and healthcare providers to assess the acceptability and experiences of the SMS program, aiming to improve diabetes management in this underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short messaging service (SMS) texting for uncontrolled diabetes among persons experiencing homelessness: Study protocol for a randomized trial. Asgary, R., Beideck, E., Naderi, R., et al.[2023]

Text messaging-based mindfulness interventions significantly improved outcomes related to insomnia, pain, and dysregulated eating in three randomized controlled trials involving a total of 919 participants, with effects sustained up to 3 months after the intervention.

The studies identified specific mediating factors, such as dysfunctional beliefs about sleep and pain catastrophizing, that helped explain how the interventions led to improvements in mental health and well-being, highlighting the effectiveness of text messaging as a core intervention modality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Li, AC., Wong, KK., Chio, FH., et al.[2022]

A text messaging program (TMP) significantly improved glucose control and retinopathy screening rates in a study of 20 patients with uncontrolled type 2 diabetes over 3 months.

More than 70% of participants reported positive changes in their self-care behaviors, suggesting that using technology can effectively support diabetes management, especially for those with limited access to healthcare education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text Messaging in the Patient-Centered Medical Home to Improve Glucose Control and Retinopathy Screening. Miller, JM., Phalen, AG., Crawford, A., et al.[2020]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

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]

2. England pubmed.ncbi.nlm.nih.gov

Associations of Mindfulness with Glucose Regulation and Diabetes. [2019]

3. Scotland pubmed.ncbi.nlm.nih.gov

A feasibility study on low-dose mindfulness-based stress reduction intervention among prediabetes and diabetes patients. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The Impact of Mindfulness-Based Stress Reduction on Emotional Wellbeing and Glycemic Control of Patients with Type 2 Diabetes Mellitus. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of an integrated mindfulness intervention for veterans with diabetes distress: a randomized controlled trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Use of the Serenity Prayer among adults with type 2 diabetes: a pilot study. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Stress Reduction in Women with Overweight or Obesity: A Randomized Clinical Trial. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

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]

9. United States pubmed.ncbi.nlm.nih.gov

Perceptions, Attitudes, and Experience Regarding mHealth Among Homeless Persons in New York City Shelters. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Disparities in Text Messaging Interventions to Improve Diabetes Management in the United States. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Short messaging service (SMS) texting for uncontrolled diabetes among persons experiencing homelessness: Study protocol for a randomized trial. [2023]

12. Canada pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Text Messaging in the Patient-Centered Medical Home to Improve Glucose Control and Retinopathy Screening. [2020]