Clinical trial NCT06384521: Lifestyle MIND- Feasibility of Wait-list Control
Official title: Type 2 Diabetes Prevention and Management for People With Serious Mental Illness: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Serious Mental Illness
Schizophrenia
Major Depression
Bipolar Disorder
Keywords: health disparities
integrated care
community engagement
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: Weeks 1, 10, and 20
measure: Summary of Diabetes Self-Care Activities (SDSCA) Questionnaire
timeFrame: Weeks 1, 10, and 20
measure: Hours of Active and Sedentary Behavior
timeFrame: Weeks 1, 10, and 20
measure: Number of emergency department (ED) visits and psychiatric hospitalizations
timeFrame: Weeks 1, 10, and 20
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Weeks 1, 10, and 20
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Chinyu Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: