Lifestyle MIND- Feasibility of Wait-list Control

Summary

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.

Conditions

• Type 2 Diabetes Mellitus
• Serious Mental Illness
• Schizophrenia
• Major Depression
• Bipolar Disorder

Interventions

BEHAVIORAL

Lifestyle MIND

Lifestyle MIND is implemented twice a week in the group format, including a physical activities class and a health class. The physical activity class lasts for 60 minutes. Participants engage in physical activities modified from the American College of Sports Medicine guidelines for diabetes. The health class lasts for about 2 hours and is delivered by occupational therapy faculty and students with light refreshments that are friendly for people with diabetes. The first hour of the health class involves psychoeducation and skills training for managing SMI and Type 2 Diabetes Mellitus (T2DM), including topics such as recognizing signs and symptoms of mental disorders and diabetes, goal setting, dealing with setbacks and resistance to change, celebrating culture and holidays, and establishing healthy habits and routines. The second hour of the health class is to address individual needs, social determinants of health, and any needed homework assistance.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio

  lead OTHER

Principal Investigators

• Chinyu Wu, PhD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-31

Primary Completion

2027-07-31

Completion

2027-09-30

Countries

• United States

Study Locations