Meals, Mindfulness & Moving Forward: A Multi-modal Approach to Addressing Cardiovascular Risk and Building Resilience in Youth Suffering From Psychosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
M3 Program
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.
干预措施: M3 Program (Other)
Control
Non-randomized control group. Outcomes will be compared at same time points (baseline, 6 weeks, 12 weeks).
干预措施: Control (Other)
结局指标
主要结局
Feasibility assessed by 6-week program completion by 50% of participants attending at least 60% of the program
时间窗: 6 weeks
次要结局
- 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)
- Quality of LIfe - SF12(6 and12 weeks)
研究者
Lynne Shinto
Associate Professor
Oregon Health and Science University