Culturally competent behavioral intervention for diabetes risk reduction

降低糖尿病风险的文化行为干预

基本信息

批准号：
9015437
负责人：
NANGEL M. LINDBERG
金额：
$ 62.58万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-04-01 至 2018-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9015437
关键词：
Address Adult Age Behavior Therapy Behavioral Body Weight Body Weight decreased Carbohydrates Clinic Clinical Trials Clinical effectiveness Community Health Computerized Medical Record Control Groups Data Data Collection Diabetes Mellitus Diabetes prevention Diagnosis Diet Diet Habits Dietary Fiber Dietary intake Elements Endocrinology Fasting Federally Qualified Health Center Female Food Gender Glycosylated hemoglobin A Goals Health Hispanics Individual Intervention Learning Life Life Style Lipids Low income Measurement Metabolic Marker Mexican Mexican Americans Non-Insulin-Dependent Diabetes Mellitus Not Hispanic or Latino Obesity Outcome Overweight Participant Patient Care Patients Physical activity Physicians Population Pragmatic clinical trial Prediabetes syndrome Prevalence Quality-Adjusted Life Years Randomized Randomized Clinical Trials Randomized Controlled Trials Recruitment Activity Reporting Research Research Support Risk Factors Risk Reduction Target Populations Testing Training United States Virginia Visit Vulnerable Populations Weight Weight maintenance regimen Woman Writing aged arm base cardiovascular disorder risk cardiovascular risk factor cohort community setting cost diabetes management diabetes risk diabetic economic evaluation fasting glucose follow-up food consumption food preparation fruits and vegetables glycemic control group intervention hands-on learning health disparity improved intervention effect intervention program lifetime risk meetings nutrition prevent primary outcome programs saturated fat secondary outcome skills success successful intervention therapy design therapy development tool treatment as usual trend waist circumference weight loss intervention

项目摘要

DESCRIPTION (provided by applicant): Hispanic women have the highest estimated lifetime risk of developing diabetes of all ethnic/gender groups in the US, and their prevalence rates of overweight and obesity are among the highest in the US. Currently, nearly 90 percent of Hispanic women aged 40-59 are overweight or obese. If diagnosed with Type 2 diabetes (T2D) at age 40, Hispanic women are projected to lose 12.4 life-years, and 21.5 quality-adjusted life-years. Several clinical trials have produced compelling evidence demonstrating the benefits of weight-loss interventions for both diabetic and pre-diabetic individuals, but most of the successful interventions tested in large clinical trials have been too costly for implementation in community settings, and they have not been assessed under real life conditions, targeting vulnerable populations. This pragmatic randomized clinical trial will assess the efficacy, cost, and sustainability of a culturally tailored weight-loss program targeting obese Hispanic women with pre-diabetes or T2D. The intervention will be integrated into patient care at a Federally Qualified Health Center serving over 30,000 low-income patients, and will be delivered by trained clinic staff, with minimal support from research staff. After the effectiveness clinical tral, two cohorts of clinic patients will receive the intervention in a sustainability test. This study builds on our success with a culturally-tailored weight-loss intervention designed for Hispanic women. Elements of cultural adaptation will include: women-only groups, skill-building tasks around food measurement, focus on traditional dietary habits and cultural norms regulating food preparation and consumption, interactive learning formats with a minimum of written materials, culturally congruent physical activity, and addressing acculturative concerns. Follow-up data, including change in weight, waist circumference, and diabetes outcomes, will be collected at 6-, 12-, and 18-months post randomization. Additional analyses will include the cost of delivering the intervention and assessing the intervention's sustainability. The results of this study will inform the development of interventions to prevent diabetes onset or manage T2D in this population.

描述（由申请人提供）：西班牙裔妇女在美国所有种族/性别群体中患糖尿病的终身风险最高，她们的超重和肥胖症患病率在美国最高。目前，近90％的40-59岁的西班牙裔妇女超重或肥胖。如果在40岁时被诊断出患有2型糖尿病（T2D），那么西班牙裔妇女预计将损失12.4岁的终身年份和21.5质量调整的终身寿命。几项临床试验产生了令人信服的证据，证明了减肥干预措施对糖尿病患者和糖尿病前个体的益处，但是在大型临床试验中测试的大多数成功干预措施过于成本，无法实施社区环境，并且在现实生活条件下尚未对其进行评估，以针对脆弱的人群。这项务实的随机临床试验将评估针对具有糖尿病前或T2D的肥胖西班牙裔女性的文化量身定制减肥计划的功效，成本和可持续性。该干预措施将在联邦资格的健康中心纳入患者护理，该中心为30,000多名低收入患者提供服务，并将由训练有素的诊所工作人员提供，并得到研究人员的最低支持。有效性临床TRAL之后，两名临床患者将在可持续性测试中接受干预。这项研究以我们为西班牙裔女性设计的文化减肥干预措施为基础。文化适应的要素将包括：妇女群体，围绕食物测量的技能建设任务，关注传统的饮食习惯和调节食物制备和消费的文化规范，具有最低书面材料的互动学习格式，具有文化份额的体育锻炼以及解决习惯性问题。后续数据，包括体重的变化，腰围和糖尿病结果，将在随机化后6，12和18个月内收集。其他分析将包括提供干预和评估干预措施的可持续性的成本。这项研究的结果将告知开发干预措施，以防止该人群中的糖尿病发作或管理T2D。