Promoting Health and Functioning in Persons With SMI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Change in Exercise Capacity
研究概览
简要总结
Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction, and non have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal. The researchers sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population.
详细描述
In this randomized, controlled study, 133 adults age 21 and older with serious mental illness (SMI) and poor physical fitness (BMI>25, or <10 minutes of exercise 2x over the past month) were randomized to either: a) In SHAPE Lifestyles (ISL) intervention or b) Health Club Membership and Education (HCME): consisting of a YMCA membership, educational materials on exercise and healthy diet, and an on-site introduction to the health club. The following three specific aims were addressed: 1) To compare ISL and HCME with respect to: a) participation in regular exercise and dietary change; (b) participation in preventive health care; and (c) improved fitness and health; (2) to compare ISL and HCME with respect to: (a) indicators of mental health and (b) personal self-efficacy; and (3) to explore differences in ISL and HCME with respect to (a) selected physical, metabolic, dietary, and community functioning secondary outcomes; and (b) the relationship of demographic variables and readiness to change to outcomes. ISL participants received a 6-month intensive program of one-to-one health mentoring, followed by a 3-month period of transitioning to self-directed individual and group programming, with assessments conducted at baseline, 3, 6, 9, and 12 months. If found to be effective, ISL will provide a practical approach to improving health, independent functioning, and longevity in disabled persons 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 a nursing home of 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 Exercise Capacity
时间窗: Baseline, 3-, 6-, 9-, and 12-months
Change in fitness as measured by the 6-minute walk test.
次要结局
- Change in Preventative Health Care(Baseline and 12-months)
- Change in Triglycerides and Cholesterol(Baseline, 3-, 6-, 9-, and 12-months)
- Change in Health Status(Baseline, 3-, 6-, 9-, and 12-months)
- Change in Community Functioning(Baseline, 9-, and 12-months)
- Change in Physical Measurements (Fitness)(Baseline, 3-, 6-, 9-, and 12-months)
- Change in Psychological State(Baseline, 3-, 6-, 9-, and 12-months)
- Body Mass Index(Baseline, 3-, 6-, 9-, and 12-months)
- Change in Weight(Baseline, 3-, 6-, 9-, and 12-months)
- Change in Participation in Exercise(Baseline, 3-, 6-, 9-, and 12-months)
- Change in Diet Behaviors(Baseline, 3-, 6-, 9-, and 12-months)