Health Promotion and Fitness for Younger and Older Adults With SMI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 6
- 主要终点
- Change in Weight
研究概览
简要总结
The goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (SMI) using an innovative model: In SHAPE Lifestyles. Participants are randomly assigned to the In SHAPE program or Health Club Membership and Education only.
The three specific aims of this study are to:
- To compare the treatment groups with respect to improvement in physical fitness outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and (b) indicators of physical fitness.
- To compare the treatment groups with respect to improvements in mental health outcomes, including negative symptoms, depression, and self-efficacy.
- To explore differences in the treatment groups with respect to psychosocial functioning, health status, and acute service use, and the effects of selected demographic, clinical, and health behavior variables on primary outcomes.
详细描述
Individuals with SMI die 10-25 years earlier than the general population and have disproportionately greater rates of medical comorbidity and disability associated with high rates of obesity, sedentary lifestyle, metabolic syndrome, and poor dietary habits. Despite greater costs and adverse outcomes associated with the combination of mental illness and poor physical health, little attention has been paid to the development of health promotion interventions designed to address the needs of the high-risk group of people with SMI. This study is testing an innovative approach to reducing these problems and developing a program that will potentially have a downstream effect on early mortality for the vulnerable population of people with SMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 21 or older
- •serious mental illness defined by an axis I diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia
- •persistent impairment in multiple areas of functioning (e.g., work, school, self-care)
- •body mass index (BMI) greater than 25
- •able and willing to provide informed consent
- •on stable pharmacological treatment (same psychiatric medications over prior 2 months)
排除标准
- •residing in nursing home or other institution
- •diagnosis of dementia or significant cognitive impairment (MMSE<24)
- •unable to walk one city block
- •pregnant or planning to become pregnant within the next 18 months
- •unable to speak English
- •terminal illness with life expectancy<1 year
- •current diagnosis of an active substance dependence disorder
结局指标
主要结局
Change in Weight
时间窗: Baseline, 3-, 6-, 9-, 12-, and 18-months
Change in weight over time was measured at baseline, 3-, 6-, 9-, 12-, and 18-months. Measures were weight (kg) and body mass index (kg/m2).
次要结局
- Change in Dietary Behaviors(Baseline, 6-, 12-, and 18-months)
- Change in Dietary Intake(Baseline, 6-, 12-, and 18-months)
- Change in Serum lipids(Baseline, 6-, 12-, and 18-months)
- Change in Blood Pressure(Baseline, 6-, 12-, and 18-months)
- Change in Cardiorespiratory Fitness(Baseline, 6-, 12-, and 18-months)
- Change in Physical Activity(Baseline, 3-, 6-, 9-, 12-, and 18-months)
研究者
Stephen J. Bartels
Professor of Psychiatry, of Community and Family Medicine, and of TDI
Dartmouth-Hitchcock Medical Center