Lifestyle Program for Diabetes in People with Serious Mental Illness

(MIND Trial)

Overseen By Chinyu Wu, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Unable to exercise, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called Lifestyle MIND, designed to help individuals with both serious mental illness (SMI) and diabetes manage their conditions more effectively. Researchers aim to determine if this program can improve diabetes control and overall well-being compared to those who do not participate immediately. Participants will be divided into two groups: one will start the program immediately, while the other will begin later. The trial seeks individuals with SMI who have been diagnosed with type 2 diabetes or are at risk for it and are willing to participate for 20 weeks. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance the quality of life for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on lifestyle changes rather than medication adjustments.

What prior data suggests that the Lifestyle MIND program is safe for people with serious mental illness?

Research has shown that the Lifestyle MIND program, designed for individuals with serious mental illness and diabetes, is safe. This program incorporates lifestyle changes adapted from other successful diabetes programs, focusing on improving daily habits to enhance health and are generally easy to follow.

Studies on similar lifestyle changes for individuals with severe mental illness have found these programs safe, with no major negative side effects. Participants in these studies reported no significant problems, indicating the program is likely safe for most people.

Overall, evidence suggests that the Lifestyle MIND program is a safe choice for participants, aiming to help manage diabetes without causing harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle MIND program because it offers a novel approach to managing diabetes in people with serious mental illness through comprehensive lifestyle changes. Unlike standard diabetes treatments that often focus on medication and insulin therapy, Lifestyle MIND emphasizes personalized lifestyle interventions, including diet and physical activity, which can be more empowering and holistic for patients. By integrating mental health considerations into diabetes management, this program aims to address both physical and mental health needs simultaneously, potentially improving overall well-being and adherence to healthy habits.

What evidence suggests that Lifestyle MIND is effective for diabetes in people with serious mental illness?

This trial will compare the Lifestyle MIND program with a wait-list control group. Studies have shown that a lifestyle program based on the Diabetes Prevention Program (DPP) can help people with serious mental illness (SMI) lose weight. Managing diabetes poses challenges and affects both physical and mental health. Programs like Lifestyle MIND are designed to address these challenges. Research has shown that self-management programs for long-term illnesses can improve health, making them a good option for people with SMI. Additionally, lifestyle changes can reduce anxiety and depression, common in those dealing with both diabetes and mental health issues. Overall, Lifestyle MIND aims to enhance both diabetes management and mental well-being, potentially leading to better health outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Chinyu Wu, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for individuals with serious mental illness (SMI) such as schizophrenia, bipolar disorder, or depression who also have Type 2 Diabetes. Participants should be interested in a diabetes lifestyle program called Lifestyle MIND and willing to be randomly assigned to start the program at different times.

Inclusion Criteria

Ability to respond to self-report scales and questionnaires used in the study

I have been diagnosed with type 2 diabetes or told I am pre-diabetic.

Willingness to commit to participate for 20 weeks

Exclusion Criteria

Unable to perform the moderate intensity exercise program in Lifestyle MIND

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants provide baseline data and are randomly assigned to either the intervention or wait-list control group

1 week

1 visit (in-person)

Lifestyle MIND Program

Participants in the intervention group undergo a 10-week diabetes lifestyle intervention program

10 weeks

Weekly sessions (in-person or virtual)

Self-help Group

Participants join a self-help group for 10 weeks following the Lifestyle MIND program

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after the intervention

10 weeks

Data collection at weeks 10 and 20

What Are the Treatments Tested in This Trial?

Interventions

• Lifestyle MIND

Trial Overview The study tests the effectiveness of Lifestyle MIND, a diabetes lifestyle intervention designed for people with SMI. It compares blood sugar control, self-management of diabetes, physical activity levels, emergency visits, psychiatric hospitalizations, and overall well-being between two groups: one receiving the intervention immediately and another on a wait-list.

How Is the Trial Designed?

Group I: Wait-list control arm Experimental Treatment 1 Intervention

Delayed Lifestyle MIND

Group II: Intervention Arm Experimental Treatment 1 Intervention

Lifestyle MIND

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

Individuals with schizophrenia or schizoaffective disorders have a significantly higher prevalence of type II diabetes, prompting the need for effective treatment strategies.

The review found that diabetes education programs that include diet and exercise components, while addressing cognitive and motivational challenges, are effective in managing type II diabetes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective lifestyle interventions to improve type II diabetes self-management for those with schizophrenia or schizoaffective disorder: a systematic review. Cimo, A., Stergiopoulos, E., Cheng, C., et al.[2021]

A telephonic lifestyle coaching intervention for psychiatric outpatients led to significant weight loss and improved health over 12 months, with 46% of participants losing 5% or more of their baseline weight.

The study found that having support from a caregiver reduced dropout rates, highlighting the importance of social support in maintaining participation in lifestyle interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evaluation of a telephonic wellness coaching intervention for weight reduction and wellness improvement in a community-based cohort of persons with serious mental illness. Temmingh, H., Claassen, A., van Zyl, S., et al.[2022]

The Mind-Body Well-being Initiative is a residential treatment model that integrates mental and physical health care, specifically designed for individuals with severe mental illness (SMI) who often face significant health disparities.

This initiative aims to close the 15-20 year life expectancy gap in SMI patients by addressing both their mental health and chronic physical health conditions through a comprehensive Lifestyle Medicine approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Mind-Body Well-being Initiative: a better lifestyle for people with severe mental illness. Lalley, NA., Manger, SH., Jacka, F., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-schizophrenia-5-2024-d5b67

Lifestyle Program for Diabetes in People with Serious ... Research shows that a lifestyle program adapted from the Diabetes Prevention Program (DPP) for people with serious mental illness led to an average weight loss ...

2. academic.oup.com academic.oup.com/jcem/article/110/Supplement_2/S131/8042169

Mind Matters: Mental Health and Diabetes Management Managing diabetes is an intensive, lifelong responsibility that significantly impacts a person's mental health and diabetes outcomes.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4928189/

Barriers to Self-Management of Serious Mental Illness and ... It has been demonstrated that chronic disease self-management programs can lead to improved health outcomes. However, there are few practical and effective ...

4. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06130-2

Improvement in symptoms of anxiety and depression in ... The present study aimed to assess the impact of an online intensive lifestyle intervention (ILI) on mental health outcomes (depression and anxiety) in patients ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0022399922002355

Flourishing mental health and lifestyle behaviours in adults ... Only in T2DM, people with flourishing mental health had more optimal lifestyle behaviours compared to people with moderate mental health.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11628432/

Mind in Metabolism – A Comprehensive Literature Review on ... This literature review provides an analysis of the relationship between diabetes and mental illnesses through exploring epidemiology, shared risk factors, and ...

7. wchh.onlinelibrary.wiley.com wchh.onlinelibrary.wiley.com/doi/full/10.1002/pdi.2516

Transforming the diabetes outcomes for people with mental ... Severe mental illness is associated with a twofold increased risk of diabetes, and the onset of diabetes is approximately 10 years earlier in ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10443902/

Changes among Patients with Co-Occurring Diabetes and ... This study examined changes in patient-level outcomes among adults with diabetes and serious mental illness following introduction of an intervention ...

9. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2022.966029/full

Lifestyle interventions for people with a severe mental ... We performed a systematic review and meta-analysis to assess the effect of lifestyle interventions on mental and physical health in people with SMI in SHF.