Lifestyle MIND- Feasibility of Wait-list Control (MIND)

March 9, 2026 updated by: The University of Texas Health Science Center at San Antonio

Type 2 Diabetes Prevention and Management for People With Serious Mental Illness: A Feasibility Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Specific Aims 1 and 2

Study Design:

The study team will do a study called a randomized wait-list control trial. This means the investigators will randomly choose who gets the program first and who waits. Those in the program group will get a 10-week Lifestyle MIND program and then join a self-help group for 10 weeks. The waitlist group will wait for 10 weeks and then get the 10-week Lifestyle MIND program.

Participants:

The study team will recruit 20 people from a program for homeless adults in San Antonio, TX, who often have serious mental illness (SMI). The study team will invite them to an information session to explain the study. After agreeing to join, participants will sign a form and give some basic information after which the study team will randomly assign them to either start the program right away or wait for 10 weeks.

Data Collection and Analysis:

The study team will collect data from all participants at the beginning, after 10 weeks, and after 20 weeks.

Specific Aim 3

To address this aim, the study team will do a qualitative study. Six healthcare professionals, administrators, or leaders who work with people who have both serious mental illness and type 2 diabetes will be interviewed. Questions asked will be:

What works well for helping people with SMI manage their diabetes? What challenges do they face in helping these patients? What could be done to allow them help these patients obtain the best outcomes?

The study team will record and write down the interviews and use a method called thematic analysis to understand the main ideas. We'll use a computer program called NVivo to help us with this.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • a diagnosis of SMI
  • a diagnosis of T2DM, seeing a health care provider for T2DM, or having been informed by a healthcare provider for being pre-diabetic or diabetic
  • willingness to commit to participate for 20 weeks
  • ability to respond to self-report scales and questionnaires used in the study

Exclusion Criteria:

  • unable to perform the moderate intensity exercise program in Lifestyle MIND

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm
Lifestyle MIND
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.
Other: Wait-list control arm
Delayed Lifestyle MIND
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c (HbA1c)
Time Frame: Weeks 1, 10, and 20
This is a blood glucose test used to indicate a patient's average blood glucose level in the recent three months. It is a blood glucose measure that's not dominantly affected by the immediate physiological status (e.g., food intakes) at the time of blood drawn. An HbA1c level of 6.5% or higher is diabetic, 5.7 % to 6.4%, prediabetic, and below 5.7%, normal. We will coordinate with the study site and schedule a licensed nurse to take blood samples in designated weeks.
Weeks 1, 10, and 20
Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire
Time Frame: Weeks 1, 10, and 20
This is a self-report questionnaire with 11 items to measure a participant's compliance with diabetes self-management including diet, exercise, blood glucose tests, foot care, and smoking status. This questionnaire has been commonly used in diabetes lifestyle intervention studies with good validity and reliability. The Spanish version of this questionnaire is available upon request. Each of the first 10 items is scored on a five-point Likert scale indicating the frequency of the specified behavior as 0 = never to 4 = always. The range of possible scores is 0-40 with a higher score indicating better self management.
Weeks 1, 10, and 20
Hours of Active and Sedentary Behavior
Time Frame: Weeks 1, 10, and 20
This is measured by an ActiGraph device which participants will wear on their wrist for a week in Week 1, Week 10, and Week 20. Data of four consecutive days, including the weekend, will be used to calculate the number of hours a participant spends for active and sedentary behaviors. In older adults, the reliability of the ActiGraph measured during daily free-living activities ranged from moderate to excellent (interclass correlation coefficients [ICC]= .75-.89) across intensity categories (i.e., light and moderate intensities) and daily number of steps. In healthy middle-aged adults, the ActiGraph has shown moderate to excellent reliability (ICCs ranged from .74 to .90.
Weeks 1, 10, and 20
Number of emergency department (ED) visits and psychiatric hospitalizations
Time Frame: Weeks 1, 10, and 20
ED visits and psychiatric hospitalizations are often the result of poorly managed illness conditions. We will record self-report numbers of ED visits and psychiatric hospitalizations one year before and during the study period.
Weeks 1, 10, and 20
Satisfaction with Life Scale (SWLS)
Time Frame: Weeks 1, 10, and 20
This is a 5-item self-report measure of subjective well-being, which is widely used in health research and has good psychometric properties confirmed with the population with SMI. The SWLS total score ranges from 5 to 35, and higher scores indicate better subject well-being. The Spanish translation of SWLS is available upon request.
Weeks 1, 10, and 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Principal Investigator: Chinyu Wu, PhD, The University of Texas Health Science Center at San Antonio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000500

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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