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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to examine if it is feasible to randomly assign people into two groups and participate in Lifestyle MIND (Mental Illness and/N' Diabetes) at two different times. Lifestyle MIND is a diabetes lifestyle intervention recently developed for people with serious mental illness (SMI). It is known to be helpful for people with SMI who complete it, but the investigators do not know the effect in comparison to those who do not participate in it. The main questions it aims to answer are: * Does Lifestyle MIND improve diabetes control among people with SMI? * Will the effect of Lifestyle MIND be sustained 10 weeks after program completion? * From the provider's perspective, what are the barriers of achieving optimal diabetes treatment outcomes for patients with SMI? Researchers will compare outcomes of participants in the intervention with those in the wait-list control arm, to see if there will be significant differences in blood glucose level, compliance of diabetes self-management, time staying active, number of emergency department (ED) visits and psychiatric hospitalization, and subjective well-being.

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 data supports the effectiveness of the treatment Lifestyle MIND for diabetes in people with serious mental illness?

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 of 19 lbs and increased physical activity, which are important for managing diabetes. Additionally, a telephonic lifestyle coaching intervention resulted in significant weight reduction and improved health in individuals with psychiatric disorders, suggesting that similar lifestyle interventions can be effective. ^{1 2 3 4 5}

Is the Lifestyle Program for Diabetes in People with Serious Mental Illness safe?

The Lifestyle Program, including adaptations like the Diabetes Prevention Program for individuals with serious mental illness, has been shown to be safe. Participants in these studies experienced weight loss and improved health without reported safety concerns. ^{1 2 4 5 6}

How is the Lifestyle MIND treatment different from other treatments for diabetes in people with serious mental illness?

The Lifestyle MIND treatment is unique because it adapts the Diabetes Prevention Program specifically for individuals with serious mental illness, focusing on lifestyle changes like diet and exercise to reduce diabetes risk and promote weight loss. This tailored approach addresses the unique needs of this population, who are at a higher risk for diabetes, and emphasizes a holistic mind-body well-being program. ^{4 7 8 9 10}

Research Team

Chinyu Wu, PhD

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

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 a serious mental illness.

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

Exclusion Criteria

Unable to perform the moderate intensity exercise program in Lifestyle MIND

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

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

Best practices: surveillance and management of diabetes in a CMHC population. [2017]

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

Behavioral interventions for antipsychotic medication-associated obesity: a randomized, controlled clinical trial. [2019]

3. Ireland pubmed.ncbi.nlm.nih.gov

Severe mental illness and quality of care for type 2 diabetes: A retrospective population-based cohort study. [2023]

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

Case study of an adaptation and implementation of a Diabetes Prevention Program for individuals with serious mental illness. [2018]

5. United States 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. [2022]

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

The STRIDE weight loss and lifestyle intervention for individuals taking antipsychotic medications: a randomized trial. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The Mind-Body Well-being Initiative: a better lifestyle for people with severe mental illness. [2022]

8. England 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. [2021]

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

A 12-Week Evidence-Based Education Project to Reduce Cardiovascular and Metabolic Risk in Adults With Serious Mental Illness in the Integrated Care Setting. [2021]

10. Netherlands pubmed.ncbi.nlm.nih.gov

A cognitive/behavioral group intervention for weight loss in patients treated with atypical antipsychotics. [2018]