Lifestyle Program for Diabetes in People with Serious Mental Illness (MIND Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByChinyu Wu, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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

No Placebo Group

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.

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

I have been diagnosed with a serious mental illness.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Group I: Wait-list control armExperimental Treatment1 Intervention

Delayed Lifestyle MIND

Group II: Intervention ArmExperimental Treatment1 Intervention

Lifestyle MIND