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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02398292
Acronym
M3
Enrollment
33
Registered
2015-03-25
Start date
2015-02-28
Completion date
2016-07-31
Last updated
2019-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychotic Disorders, Schizophrenia

Brief summary

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

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.

Interventions

OTHERM3 Program

Participants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum.

OTHERControl

Participants will not participate in M3 program but will have same outcomes measured at same time points (baseline, 6 weeks, 12 weeks).

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
15 Years to 25 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program6 weeks

Secondary

MeasureTime frameDescription
Waist Circumference6 and12 weekswaist circumference measured in cm
Lipid Panel6 and12 weekstotal cholesterol, triglycerides, HDL, LDL
Body Mass Index6 and12 weeksbody mass index
Connor-Davidson Resilience Scale6 and12 weeksA 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.
Quality of LIfe - SF126 and12 weeks: 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.
Quick Scale for the Assessment of Negative Symptoms and Positive Symptoms6 and12 weeksA 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026