Type 2 Diabetes MellitusMINDNCT06384521
Lifestyle MIND- Feasibility of Wait-list Control
A study testing Lifestyle MIND in people with Type 2 Diabetes Mellitus and Serious Mental Illness, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Serious Mental Illness, Schizophrenia
- What is being tested?
- Lifestyle MIND
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unable to perform the moderate intensity exercise program in Lifestyle MIND
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Serious Mental Illness, Schizophrenia, Major Depression, Bipolar Disorder
- Being tested
- Lifestyle MIND
- Keywords
- health disparities, integrated care, community engagement
- Medical subject headings
- Diabetes Mellitus, Type 2, Schizophrenia, Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle MINDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Lifestyle MIND Receives: Behavioral: Lifestyle MIND |
| Wait-list control arm | Other | Delayed Lifestyle MIND Receives: Behavioral: Lifestyle MIND |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1c (HbA1c)
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.
Measured: Weeks 1, 10, and 20
Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire
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.
Measured: Weeks 1, 10, and 20
Hours of Active and Sedentary Behavior
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.
Measured: Weeks 1, 10, and 20
Number of emergency department (ED) visits and psychiatric hospitalizations
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.
Measured: Weeks 1, 10, and 20
Satisfaction with Life Scale (SWLS)
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.
Measured: Weeks 1, 10, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study startDec 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Why it stopped: No funding obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chinyu Wu, PhD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384521
- Sponsor's protocol ID
- STUDY00000500
- Acronym
- MIND
- Status last verified
- Mar 2026
- First submitted
- 22 Apr 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 2 Diabetes Prevention and Management for People With Serious Mental Illness: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06384521
- Acronym / sponsor ID
- MIND / STUDY00000500
- Conditions
- Type 2 Diabetes Mellitus, Serious Mental Illness, Schizophrenia, Major Depression, Bipolar Disorder
- Keywords
- health disparities, integrated care, community engagement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Lifestyle MINDLifestyle MIND |
| Wait-list control arm | Other | Behavioral: Lifestyle MINDDelayed Lifestyle MIND |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- unable to perform the moderate intensity exercise program in Lifestyle MIND
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle MINDLifestyle 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. | Behavioural | Intervention Arm, Wait-list control arm |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chinyu Wu, PhD principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle MIND in people with Type 2 Diabetes Mellitus and Serious Mental Illness, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1c (HbA1c) (time frame: Weeks 1, 10, and 20). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.