Weight Management & Wellness for People With Psychiatric Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 主要终点
- Change in Perceived Competence Scale from Baseline to 8-months
研究概览
简要总结
The purpose of this study is to conduct a randomized controlled trial to test the effectiveness of an intervention called Nutrition and Exercise for Wellness and Recovery (NEW-R) in promoting healthy eating and increased physical activity for better weight management among psychiatric outpatients.
详细描述
Weight management is a serious issue for individuals with mental health conditions, especially those who are taking psychiatric medications. The latest estimates are that over half of individuals receiving community mental health services are overweight or obese. This project's objective is to conduct a randomized controlled trial to test the effectiveness of an intervention called Nutrition and Exercise for Wellness and Recovery (NEW-R) in promoting healthy eating and increased physical activity for better weight management among psychiatric outpatients living and working in the community. It is an 8-week, recovery-oriented intervention that is co-led by a trained health educator and a certified mental health peer specialist. The study will take place at the UIC Department of Psychiatry in Chicago. Research participants will be recruited from the Department's outpatient clinics and other community programs, and randomly assigned to receive NEW-R along with services as usual or services as usual alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis with a mental health disorder
- •Patient of outpatient program
- •Age 18 or older
- •Being overweight or obese defined as BMI>=25
- •Ability to understand spoken English
排除标准
- •Residing in a nursing home
- •Cardiac event in past 6 months
- •Past episode of anorexia or bulimia
- •Pregnancy
- •Diagnosis with a terminal illness expected to result in death within 1 year
- •Active alcohol or substance abuse or dependence
- •Inability to provide informed consent due to diagnosis of dementia or cognitive impairment
- •Inability to understand spoken English
结局指标
主要结局
Change in Perceived Competence Scale from Baseline to 8-months
时间窗: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Measures ability to stick with a weight management regimen and master new knowledge about diet and exercise. This 4-item scale using a 7-point Likert response format ranging from "not at all true" to "very true". The minimum value is 4 and the maximum is 28, with higher scores indicating a better outcome.
Change in Health Promoting Lifestyle Profile from Baseline to 8-months
时间窗: Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3
Measure of health promoting behavior. This is a 26-item scale with a 4-point Likert response format ranging from "never" to "routinely". Minimum value for this scale is 26 and the maximum is 104, with higher scores indicating a better outcome. The dimensions include nutrition, spirituality, and physical activity.
次要结局
- Change in Weight from Baseline to 8-months(Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)
- Change in Self-Rated Abilities for Health Practices Scale from Baseline to 8-months(Study entry (Pre-intervention/T1), 2-months later (Post-Intervention 1/T2), & 6-months after T2 (Post-Intervention 2/T3)
研究者
Judith A. Cook
Professor
University of Illinois at Chicago