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: 10618309
• 负责人: PHILLIPPE Belton CUNNINGHAM
• 金额: $ 73.1万
• 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/10618309
• 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; Educational process of instructing; Effectiveness; Eligibility Determination; 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; Phase Ia Trial; Phase Ib Trial; Physical activity; Play; Population; Procedures; Protocols documentation; Public Health; Randomized; Research; Research Priority; Risk; Risk Factors; Science; Sequential Multiple Assignment Randomized Trial; Series; Societies; South Carolina; Stroke; Stroke Belt; Symptoms; Testing; Training; Translating; United States National Institutes of Health; Vulnerable Populations; Weight; Weight maintenance regimen; Youth; acceptability and feasibility; aged; attentional control; behavioral clinical trial; bench-to-bedside translation; 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; randomized, clinical trials; recruit; satisfaction; secondary outcome; skill acquisition; skills; skills training; translational research program

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.

摘要：儿童和成年人的肥胖率令人震惊，尤其是少数民族中的肥胖率 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。南卡罗来纳州（SC）是“中风腰带”的一部分，具有第三高的肥胖率 在美国儿童中，美国成年人中的肥胖率为39.2％，肥胖率为第122.3％。很遗憾， SC中的非裔美国人超重或肥胖的可能性更高（成年人中有75.7％，其中40％ 儿童），这使他们处于相当高风险的肥胖相关疾病，例如哮喘，类型2 糖尿病，心血管疾病，高血压，中风和某些形式的癌症。这个公共卫生挑战 由于缺乏专门针对满足独特需求而定制的可用干预策略，使得更加复杂 少数民族。这项R01随机临床试验，由最近完成的结果告知 NHLBI/NICHD中心赠款（“适合家庭项目”，U01HL097889; Pi-Naar）遵循国家心脏的心 肺部和血液研究所，肥胖相关行为干预试验（轨道）模型 与可靠的注意力控制相比，行为干预措施将检查适合家庭的效率 健康）状况。适合家庭的四个基于证据的行为组成部分（家庭服务， 应急管理，动机访谈，认知行为技能培训）是根据文化量身定制的 并通过概念验证顺序进行多个随机试验进行了优化，该试验会导致体重减轻 非裔美国人青少年，一个众多且知名的人群。一百八十个肥胖非洲人 年龄12-17岁的美国青少年及其主要照顾者将被随机分配给两个 治疗条件：1）适合家庭或2）家庭支持（HBFS）注意力控制条件。它 预测，适合家庭将导致青少年和护理人员超重减少， 并增加了体育活动和基于证据的体重管理行为（自我 监测饮食和运动）。如果有效，适合家庭，该家庭经过精心开发和改编 轨道的成功阶段有可能减少与肥胖相关疾病的分布 （心血管和代谢）通过解决非洲裔美国家庭及其多种危险因素及其 青春期的孩子。这是这个项目在潜在的公共卫生影响方面具有很高的意义， 与肥胖相关的医疗保健成本的降低。