Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-14 @ 4:14 PM
Study NCT ID:
NCT02398292
Status:
COMPLETED
Last Update Posted:
2019-05-28
First Post:
2015-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youths With Psychosis
Sponsor:
Oregon Health and Science University
Organization:
Study Overview
Official Title:
Meals, Mindfulness & Moving Forward: A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youth Suffering From Psychosis
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
M3
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: