A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis

Study Overview
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Brief Summary
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The purpose of this study is to determine the feasibility (≥ 50% completion rate) of a 6-week nutrition, movement, and mindfulness program for youth with recent diagnosis of psychosis.

Detailed Description
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The purpose of this study is to determine the feasibility of a 6-week nutrition, movement, and mindfulness program (M³ Program) for youth with a recent diagnosis of psychosis. Program effects on metabolic and mental health outcomes compared to wait-list control will also be assessed. Participants will be 15-25 years of age, and have a recent diagnosis of psychosis. Twenty participants and their study partners (20 study partners) will be equally divided into two cohorts. Participants will sign up for one of the two series on a rolling enrollment basis until both of the program date frames are filled. Participants that signed up for the second series will serve as a wait-list control; outcomes from the participants in the first series will be compared to this group. M³ will be a combination of didactic and experiential training. The course will meet once-a-week for six weeks. Participants will learn how to prepare healthy snacks and meals, make healthy choices when eating out, and interpret food packaging and labels. They will also learn about different forms of mindfulness exercises and movement, such as yoga, martial arts, and a Japanese style of drumming. Feasibility will be assessed throughout the program.

Official Title
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Meals, Mindfulness & Moving Forward: A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youth Suffering From Psychosis

Conditions
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Psychotic Disorders, Schizophrenia

Intervention / Treatment
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* Other: M3 Program
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First diagnosis of psychosis occurs within 3 years of enrollment into the study or are a graduate of the Early Assessment and Support Alliance Program (EASA). Established mental health provider and primary care physician. Age 15 to 25 years (inclusive) Able to enroll with a study partner (study partner can be a healthy volunteer) Able to read and write in English Exclusion Criteria: Active suicidal or homicidal thoughts Mental status exam which suggests high risk for disruptiveness to group process or danger to self and others. If a graduate of EASA, the participant must have a primary care or mental health provider.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: M3 Program<br>Non-randomized experimental group. The program is a six-week multi-modal intervention, including nutrition education and cooking classes, physical activity, and mindfulness. Outcomes will be compared to a non-randomized control group. | Other: M3 Program<br>* Participants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum.<br>* Other names: Meals, Mindfulness and Moving Foward Program;|
| Other: Control<br>Non-randomized control group. Outcomes will be compared at same time points (baseline, 6 weeks, 12 weeks). | Other: Control<br>* Participants will not participate in M3 program but will have same outcomes measured at same time points (baseline, 6 weeks, 12 weeks).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index | body mass index | 6 and12 weeks | 
| Waist Circumference | waist circumference measured in cm | 6 and12 weeks | 
| Lipid Panel | total cholesterol, triglycerides, HDL, LDL | 6 and12 weeks | 
| Quick Scale for the Assessment of Negative Symptoms and Positive Symptoms | A rating scale to measure positive symptoms of schizophrenia. The QSANS-QSAPS assessment is administered by a trained health professional and takes 30 to 45 minutes to complete. | 6 and12 weeks | 
| Connor-Davidson Resilience Scale | A measurement of 'hardiness', or one's ability to successfully cope with stress. The scale draws on a number of resilient characteristics, including patience, tolerance to negative affect, sense of humor, commitment, recognition of limits to control, engaging the support of others, and adaptability. The CD-RISC contains 25 items and asks subjects to rate how they felt over the past month on a Likert-type scale. Total score range is 0 - 100, with higher scores indicating higher levels of resiliency. | 6 and12 weeks | 
| Quality of LIfe - SF12 | : The SF-12 is a 12-item validated shortened version of the SF-36 and was designed to provide a health related quality of life measure that was quick and easy to administer in large population studies. The SF-12 contains a subset of the 12 items from the SF-36 and information from this subset of questions is used to construct a physical and mental component summary score. | 6 and12 weeks |