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Completed

NCT Number: NCT02398292

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

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.

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Key information

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

M3 Program

Other

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

Other names: Meals, Mindfulness and Moving Foward Program

Control

Other

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

Primary outcomes

  1. Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program

    Time frame: 6 weeks

Secondary outcomes

  1. Body Mass Index

    Time frame: 6 and12 weeks

    body mass index

  2. Waist Circumference

    Time frame: 6 and12 weeks

    waist circumference measured in cm

  3. Lipid Panel

    Time frame: 6 and12 weeks

    total cholesterol, triglycerides, HDL, LDL

  4. Quick Scale for the Assessment of Negative Symptoms and Positive Symptoms

    Time frame: 6 and12 weeks

    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.

  5. Connor-Davidson Resilience Scale

    Time frame: 6 and12 weeks

    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. Quality of LIfe - SF12

    Time frame: 6 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.

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Official study title

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

Acronym: M3

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 25, 2015
Registry last updated
May 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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