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，主要是因为它们对 II 型糖尿病和其他心血管疾病危险因素的影响。患有严重精神疾病的人是一大批得不到充分服务的人群，他们患肥胖症、糖尿病、代谢综合征和随后早期死亡的风险大大增加。通常用于治疗这些精神疾病的抗精神病药物会放大这些风险。 尽管强有力的证据表明，生活方式干预措施可有效减轻普通人群的体重和其他糖尿病危险因素，并且试点和可行性研究表明此类干预措施对患有精神疾病的个体有效，但尚未有大规模转化试验在该人群中检验此类干预措施。为了响应 PAR-06-532“预防和控制糖尿病的转化研究”，本申请旨在填补这一证据空白。 我们提出了一项随机对照试验，以检验先前被证明可有效减轻体重和糖尿病危险因素的生活方式干预措施在精神疾病人群中的有效性。我们的目标是一群服用抗精神病药物的个体 (n = 280)，他们在两种临床环境之一接受治疗——公共资助的行为健康护理诊所和非营利性私人健康计划。来自每个临床环境的顾问将接受干预培训，并与研究人员配合实施干预，提高普遍性，并提高未来采用的可能性。该干预措施促进适度减少热量、改变饮食和增加能量消耗，并基于当前治疗肥胖和心血管疾病的临床实践指南。 具体目标检验了干预措施在以下方面比常规护理更有效的假设：1）减轻体重和体重指数； 2）降低空腹胰岛素水平，增加胰岛素敏感性； 3) 降低总胆固醇和低密度脂蛋白胆固醇，并在 6、12 和 24 个月时评估结果。第四个目标探讨动机、社会支持和结果预期对主要结果的影响，以及干预效果的调节因素（种族、性别、精神疾病诊断群体、药物类型、代谢综合征）。实施和过程评估将评估干预实施的保真度，评估其可接受性；确定参与者认为最有帮助和最没有帮助的组件；确定生活方式改变的障碍和促进因素；并评估干预措施对身体形象、精神症状、抗精神病药物依从性、生活质量、健康相关自我效能、健康、功能状态和社会支持的影响。成本效益分析将评估改​​变每个主要结果（体重、BMI、空腹胰岛素水平、胰岛素敏感性和胆固醇）的增量成本。 公共健康相关性：本研究将检验旨在减轻体重和糖尿病危险因素的生活方式改变计划对于患有严重精神疾病的人是否有效。如果结果是积极的，它可以帮助精神疾病患者改善健康并降低患糖尿病的风险。

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.