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

NCT02398292 | Completed DMC

• 1 other identifier: 10376
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (6)

• Body Mass Index

  6 and12 weeks

• Waist Circumference

  6 and12 weeks

• Lipid Panel

  6 and12 weeks

• Quick Scale for the Assessment of Negative Symptoms and Positive Symptoms

  6 and12 weeks

• Connor-Davidson Resilience Scale

  6 and12 weeks

Study Arms (2)

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.

Other: M3 Program

Control

OTHER

Non-randomized control group. Outcomes will be compared at same time points (baseline, 6 weeks, 12 weeks).

Other: Control

Interventions

M3 Program OTHER

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

Also known as: Meals, Mindfulness and Moving Foward Program

M3 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).

Control

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Meals; Mindfulness

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Lynne Shinto, ND, MPH

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Craigan Usher, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 20, 2015
• First Posted: March 25, 2015
• Study Start: February 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: May 28, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)