Reducing Weight and Diabetes Risk in an Underserved Population

描述（由申请人提供）：超重和肥胖是美国可预防死亡的主要原因之一，主要通过其对II型糖尿病和其他心血管疾病风险因素的影响。患有严重精神疾病的个体代表了大量服务不足的人群，他们患肥胖症、糖尿病、代谢综合征和随后的早期死亡的风险大大增加。这些风险被通常用于治疗这些精神疾病的抗精神病药物放大。 虽然强有力的证据表明，生活方式干预措施在降低一般人群的体重和其他糖尿病风险因素方面是有效的，而且试点和可行性研究表明，这种干预措施对患有精神疾病的人有效，但没有大规模的转化试验在这一人群中检查过这种干预措施。在回应PAR-06-532“糖尿病预防和控制的转化研究”时，本申请旨在填补这一证据空白。 我们提出了一个随机对照试验，以检查的有效性，在精神病患者群体中，生活方式干预以前被证明是有效的，以减少体重和糖尿病的危险因素。我们的目标是一组服用抗精神病药物的人（n = 280），他们在两个临床环境中接受治疗-一个是公共资助的行为健康护理诊所，另一个是非营利性的私人健康计划。来自每个临床环境的顾问将接受干预培训，并与研究人员配对以提供干预，增加普遍性，并提高未来采用的可能性。该干预措施促进适度减少热量，改变饮食，增加能量消耗，并基于目前治疗肥胖和心血管疾病的临床实践指南。 具体目标测试的假设，干预是更有效的比常规护理：1）降低体重和BMI; 2）降低空腹胰岛素水平和增加胰岛素敏感性;和3）降低总胆固醇和LDL胆固醇，在6个月，12个月和24个月的结果进行评估。第四个目标探讨了动机，社会支持和预期结果对主要结果的影响，以及干预有效性的调节因素（种族，性别，精神疾病诊断组，药物类型，代谢综合征）。实施和过程评估将评估干预交付的保真度，评估其可接受性;确定参与者认为最有用和最不有用的组件;确定生活方式改变的障碍和促进因素;并评估干预对身体形象，精神症状，抗精神病药物的依从性，生活质量，健康相关的自我效能，健康，功能状态和社会支持的影响。成本效益分析将评估每个主要结局（体重、BMI、空腹胰岛素水平、胰岛素敏感性和胆固醇）发生变化的增量成本。 公共卫生相关性：这项研究将检查是否生活方式改变计划，以减少体重和糖尿病的危险因素将是有效的人与严重的精神疾病。如果结果是积极的，它可以帮助精神疾病患者改善健康状况，降低糖尿病风险。

DESCRIPTION (provided by applicant): Overweight and obesity are among the leading causes of preventable deaths in the US, primarily through their effects on Type II diabetes mellitus and other cardiovascular disease risk factors. Individuals with serious mental illness represent a large underserved population at greatly increased risk of obesity, diabetes, metabolic syndrome, and subsequent early mortality. These risks are amplified by the antipsychotic agents that are often prescribed to treat these mental conditions. Although strong evidence indicates that lifestyle interventions are effective at reducing weight and other diabetes risk factors in general populations, and pilot and feasibility studies suggest that such interventions will be effective with individuals who have mental illnesses, no large-scale translational trials have examined such interventions in this population. In responding to PAR-06-532, "Translational Research for the Prevention and Control of Diabetes," this application seeks to fill that evidence gap. We propose a randomized controlled trial to examine the effectiveness, in a mentally ill population, of a lifestyle intervention previously shown to be effective for reducing weight and diabetes risk factors. We target a group of individuals taking antipsychotic agents (n = 280) who receive treatment in one of two clinical settings - a publicly funded behavioral health care clinic and a non-profit private health plan. Counselors from each clinical setting will be trained in the intervention and paired with study staff to deliver it, increasing generalizability, and improving the probability of future adoption. The intervention promotes moderate calorie reduction, dietary changes, and increased energy expenditure, and is based on current clinical practice guidelines for treating obesity and cardiovascular disease. Specific aims test the hypotheses that the intervention is more effective than usual care in: 1) reducing weight and BMI; 2) reducing fasting insulin levels and increasing insulin sensitivity; and 3) reducing total cholesterol and LDL cholesterol, with outcomes assessed at 6, 12, and 24 months. A fourth aim explores effects of motivation, social support, and outcomes expectancies on primary outcomes, and moderators of intervention effectiveness (ethnicity, gender, mental illness diagnostic group, medication type, metabolic syndrome). Implementation and process evaluations will assess the fidelity of intervention delivery, evaluate its acceptability; identify components participants find most and least helpful; identify barriers to, and facilitators of, lifestyle changes; and evaluate the effects of the intervention on body image, psychiatric symptoms, adherence to antipsychotic medications, quality of life, health-related self-efficacy, health, functional status, and social support. Cost-effectiveness analyses will evaluate incremental costs of producing change in each primary outcome (weight, BMI, fasting insulin levels, insulin sensitivity, and cholesterol). PUBLIC HEALTH RELEVANCE: This study will examine whether a lifestyle change program to reduce weight and diabetes risk factors will be effective among people with serious mental illnesses. If the results are positive, it could help people with mental illness improve their health and reduce their diabetes risk.