Clinical Trial of the Fit Families Multicomponent Obesity Intervetnion for African American Adolescents and Their Caregivers: Next Step from the ORBIT Initiative

针对非裔美国青少年及其照顾者的 Fit Families 多成分肥胖干预的临床试验：ORBIT Initiative 的下一步

• 批准号: 10417377
• 负责人: PHILLIPPE Belton CUNNINGHAM
• 金额: $ 74.64万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10417377
• 关键词: Address; Adolescent; Adult; Advisory Committees; African American; African American population; Age; Asthma; Basic Science; Behavior; Behavior Therapy; Behavioral; Behavioral trial; Body Weight decreased; Cardiovascular Diseases; Cardiovascular system; Caregivers; Child; Clinical Trials; Cognitive; Communication; Community Health Aides; Cost Analysis; Costs and Benefits; Diet Monitoring; Drops; Effectiveness; Enrollment; Family; Grant; Health; Health Care Costs; Health Status; Home; Hypertension; Incentives; Intervention; Intervention Trial; Interview; Life Style; Malignant Neoplasms; Measures; Medical; Metabolic; Metabolic syndrome; Methodology; Modeling; Monitor; National Heart, Lung, and Blood Institute; National Institute of Child Health and Human Development; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Obesity associated disease; Outcome; Overweight; Phase; Physical activity; Play; Population; Procedures; Protocols documentation; Public Health; Randomized; Randomized Clinical Trials; Research; Research Priority; Risk; Risk Factors; Science; Sequential Multiple Assignment Randomized Trial; Series; Societies; South Carolina; Stroke; Stroke Belt; Supervision; Symptoms; Testing; Training; Translating; United States National Institutes of Health; Vulnerable Populations; Weight; Weight Gain; Weight maintenance regimen; Youth; acceptability and feasibility; aged; attentional control; base; behavioral clinical trial; bench to bedside; contingency management; cost; cost effectiveness; diet and exercise; disparity reduction; early phase trial; effectiveness testing; efficacy evaluation; efficacy study; efficacy testing; efficacy trial; ethnic minority; evidence base; executive function; extrinsic motivation; family support; fitness; follow-up; high risk; home based service; improved; intervention cost; intrinsic motivation; markov model; mathematical model; minority children; motivational enhancement therapy; novel; obesity risk; obesity treatment; parental role; phase III trial; primary caregiver; public health relevance; randomized trial; recruit; satisfaction; secondary outcome; skill acquisition; skills; skills training; translational research program; trial comparing

Abstract: The alarming rates of obesity among children and adults, particularly among ethnic minorities, has been identified by the National Institutes of Health as one of the most serious public health challenges facing our nation in the 21st century. South Carolina (SC), part of the “Stroke Belt,” has the 3rd highest obesity rate among US children at 39.2% and the 12th highest obesity rate among US adults at 32.3%. Unfortunately, African Americans in SC are disproportionately more likely to be overweight or obese (75.7% of adults, 40% of children), which places them at considerable high-risk for obesity-related diseases such as asthma, Type 2 diabetes, cardiovascular disease, hypertension, stroke, and some forms of cancer. This public health challenge is compounded by the lack of available intervention strategies specially tailored to meet the unique needs of ethnic minorities. This R01 randomized clinical trial, informed by the results from a recently completed NHLBI/NICHD center grant (“FIT Families Project,” U01HL097889; PI-Naar) that followed the National Heart, Lung, and Blood Institute, Obesity Related Behavioral Intervention Trials (ORBIT) model for developing behavioral interventions, will examine the efficacy of FIT Families compared to a credible attention control condition. Each of four evidence-based behavioral components of FIT Families (home-based services, contingency management, motivational interviewing, cognitive behavioral skills training) were culturally tailored and optimized through a proof of concept sequential multiple randomized trial that produced weight loss among African American adolescents, a large and understudied population. One hundred and eighty obese African American adolescents aged 12-17 and their primary caregiver will be randomly assigned to one of two treatment conditions: 1) FIT Families or 2) Home-Based Family Support (HBFS) attention control condition. It is predicted that FIT Families will lead to greater reductions in adolescent and caregiver percent overweight, and increases in physical activity and the use of evidence-based weight management behaviors (self- monitoring of diet and exercise). If effective, FIT Families, which was carefully developed and adapted through successive Phases of ORBIT, has the potential to reduce disparities in obesity-related diseases (cardiovascular and metabolic) by addressing multiple risk factors among African American families and their adolescent children. Thus, this project has high significance in terms of potential public health impact and reduction in obesity related healthcare costs.

翻译后摘要：儿童和成人，特别是少数民族的肥胖率令人震惊， 被美国国立卫生研究院确定为面临的最严重的公共卫生挑战之一， 我们的国家在21世纪世纪。南卡罗来纳州（SC），“中风带”的一部分，有第三高的肥胖率 在美国儿童中，肥胖率为39.2%，在美国成年人中，肥胖率为32.3%，排名第12位。不幸的是， SC中的非洲裔美国人超重或肥胖的可能性更大（75.7%的成年人，40%的 儿童），这使他们处于相当高的风险，与肥胖有关的疾病，如哮喘，2型 糖尿病、心血管疾病、高血压、中风和某些癌症。这一公共卫生挑战 由于缺乏专门为满足少数群体的独特需要而制定的干预战略， 少数民族。这项R 01随机临床试验，根据最近完成的一项 NHLBI/NICHD中心赠款（“FIT家庭项目”，U 01 HL 097889; PI-Naar），继国家心脏， 肺和血液研究所，肥胖相关行为干预试验（ORBIT）模型，用于开发 行为干预，将检查FIT家庭的有效性相比，一个可信的注意力控制 条件FIT家庭的四个基于证据的行为组成部分（基于家庭的服务， 应急管理，动机访谈，认知行为技能培训）进行了文化定制 并通过概念验证进行了优化，顺序多随机试验， 非裔美国青少年，一个庞大而未被充分研究的群体。180个肥胖的非洲人 12-17岁的美国青少年和他们的主要照顾者将被随机分配到两个 治疗条件：1）FIT家庭或2）基于家庭的家庭支持（HBFS）注意力控制条件。它 据预测，FIT家庭将导致青少年和照顾者超重百分比的更大减少， 增加身体活动和使用基于证据的体重管理行为（自我， 监测饮食和运动）。如果有效的话，FIT家庭，这是精心制定和调整，通过 ORBIT的连续阶段，有可能减少肥胖相关疾病的差异 （心血管和代谢）通过解决非洲裔美国人家庭及其 青春期的孩子。因此，该项目在潜在的公共卫生影响方面具有重要意义， 减少肥胖相关的医疗费用。