SchizophreniaM3NCT02398292
A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis
A study testing M3 Program in people with Schizophrenia and Psychotic Disorders, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- M3 Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Jul 2016
- 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 15 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University
Portland, Oregon, 97239
About this study
Official title: Meals, Mindfulness & Moving Forward: A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youth Suffering From 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.
Read the 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.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- M3 Program, Control
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M3 ProgramOther
Also called Meals, Mindfulness and Moving Foward Program
Participants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum.
ControlOther
Participants will not participate in M3 program but will have same outcomes measured at same time points (baseline, 6 weeks, 12 weeks).
| Study group | Role | What they receive |
|---|---|---|
| M3 Program | Other | 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. Receives: Other: M3 Program |
| Control | Other | Non-randomized control group. Outcomes will be compared at same time points (baseline, 6 weeks, 12 weeks). Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program
Measured: 6 weeks
Secondary outcomes (6)
Body Mass Index
body mass index
Measured: 6 and12 weeks
Waist Circumference
waist circumference measured in cm
Measured: 6 and12 weeks
Lipid Panel
total cholesterol, triglycerides, HDL, LDL
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 and12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynne Shinto, Oregon Health and Science University
- Investigators
- Lynne Shinto, ND, MPH, Principal investigator, Oregon Health and Science UniversityCraigan Usher, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02398292
- Sponsor's protocol ID
- 10376
- Acronym
- M3
- Status last verified
- May 2019
- First submitted
- 20 Mar 2015
- Last updated
- 28 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meals, Mindfulness & Moving Forward: A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youth Suffering From Psychosis
- ClinicalTrials.gov ID
- NCT02398292
- Acronym / sponsor ID
- M3 / 10376
- Conditions
- Schizophrenia, Psychotic Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Mar 2015 (estimated)
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M3 Program | Other | Other: M3 ProgramNon-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. |
| Control | Other | Other: ControlNon-randomized control group. Outcomes will be compared at same time points (baseline, 6 weeks, 12 weeks). |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| M3 ProgramAlso: Meals, Mindfulness and Moving Foward ProgramParticipants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum. | Other | M3 Program |
| ControlParticipants will not participate in M3 program but will have same outcomes measured at same time points (baseline, 6 weeks, 12 weeks). | Other | Control |
Primary outcome
Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program
Time frame: 6 weeks
6 secondary outcomes
Body Mass Index
Time frame: 6 and12 weeks
Waist Circumference
Time frame: 6 and12 weeks
Lipid Panel
Time frame: 6 and12 weeks
Quick Scale for the Assessment of Negative Symptoms and Positive Symptoms
Time frame: 6 and12 weeks
Connor-Davidson Resilience Scale
Time frame: 6 and12 weeks
Quality of LIfe - SF12
Time frame: 6 and12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2019.
- 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.
Lynne Shinto, ND, MPH principal investigator
Oregon Health and Science University
Craigan Usher, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing M3 Program in people with Schizophrenia and Psychotic Disorders, run by Oregon Health and Science University 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 28 May 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program (time frame: 6 weeks). 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 28 May 2019.