Reducing Weight and Diabetes Risk in an Underserved Population

降低服务不足人群的体重和糖尿病风险

• 批准号: 7500523
• 负责人: Carla A. Green
• 金额: $ 77.16万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-08-15 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7500523
• 关键词: Adherence; Adoption; Antipsychotic Agents; Body Image; Body Weight decreased; Cardiovascular Diseases; Caring; Cessation of life; Cholesterol; Clinic; Clinical; Clinical Practice Guideline; Condition; Cost Effectiveness Analysis; Counseling; Diabetes Mellitus; Diagnostic; Diet; Effectiveness; Effectiveness of Interventions; Energy Metabolism; Ethnic Origin; Evaluation; Exercise; Expectancy; Fasting; Feasibility Studies; Funding; Future; Gender; General Population; Health; Health Planning; Individual; Insulin; Intervention; LDL Cholesterol Lipoproteins; Life Style; Maintenance; Mental Health; Mental disorders; Mentally Ill Persons; Metabolic syndrome; Monitor; Motivation; Non-Insulin-Dependent Diabetes Mellitus; Numbers; Obesity; Outcome; Overweight; Participant; Pharmaceutical Preparations; Phase; Population; Prevention; Probability; Process; Professional counselor; Psyche structure; Public Health; Randomized Controlled Trials; Rate; Research; Risk; Risk Factors; Sampling; Self Efficacy; Social support; Symptoms; Target Populations; Testing; Training; Translational Research; Underserved Population; Upper arm; Weight; Weight Gain; base; behavior change; behavioral health; cardiovascular disorder risk; clinically relevant; cost; cost effectiveness; design; diabetes risk; functional status; health related quality of life; improved; indexing; insulin sensitivity; lifestyle intervention; mortality; obesity risk; obesity treatment; programs; severe mental illness; theories

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.

描述(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，主要是通过它们对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人代表着大量缺乏服务的人群，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。这些风险被经常开出的治疗这些精神疾病的抗精神病药物放大。 尽管强有力的证据表明，生活方式干预在普通人群中有效地减少体重和其他糖尿病风险因素，试点和可行性研究表明，这种干预措施将对患有精神疾病的个人有效，但还没有大规模的转化性试验检验这种干预措施在这一人群中的作用。为了回应PAR-06-532，“糖尿病预防和控制的翻译研究”，本申请寻求填补这一证据空白。 我们建议进行一项随机对照试验，以检验生活方式干预在精神疾病人群中的有效性，此前已证明生活方式干预对减轻体重和糖尿病风险因素有效。我们的目标是一组服用抗精神病药物的个体(n=280)，他们在两种临床环境中的一种接受治疗-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咨询师将接受干预培训，并与研究人员配对提供干预，增加普适性，并提高未来采用的可能性。该干预措施促进适度减少卡路里，改变饮食，增加能量消耗，并基于目前治疗肥胖症和心血管疾病的临床实践指南。 特定的目标验证了这样的假设，即干预在以下方面比通常的护理更有效：1)减少体重和BMI；2)降低空腹胰岛素水平和提高胰岛素敏感性；3)降低总胆固醇和低密度脂蛋白胆固醇，结果分别在6个月、12个月和24个月进行评估。第四个目标是探索动机、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、精神疾病诊断组、用药类型、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帮助和最不有帮助的部分；确定改变生活方式的障碍和促进者；以及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、与健康相关的自我效能、健康、功能状况和社会支持的影响。成本效益分析将评估在每个主要结果(体重、BMI、空腹胰岛素水平、胰岛素敏感性和胆固醇)方面产生变化的增量成本。 与公共健康相关：这项研究将检验旨在减少体重和糖尿病风险因素的生活方式改变计划是否对患有严重精神疾病的人有效。如果结果是积极的，它可以帮助精神疾病患者改善健康状况，降低患糖尿病的风险。