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：儿童和成人，特别是少数族裔的肥胖率令人震惊。 已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 21 世纪的南卡罗来纳州 (SC) 是“中风带”的一部分，其肥胖率排名第三。 不幸的是，美国儿童肥胖率为 39.2%，美国成年人肥胖率为 32.3%，排名第 12。 南卡罗来纳州的非裔美国人超重或肥胖的可能性高得不成比例（成年人中 75.7%，成年人中 40%） 儿童），这使他们面临与肥胖相关的疾病（如哮喘、2 型哮喘）相当高的风险 糖尿病、心血管疾病、高血压、中风和某些形式的癌症。 由于缺乏专为满足特定人群的独特需求而制定的干预策略，情况变得更加复杂。 这项 R01 随机临床试验的结果来自于最近完成的一项研究。 NHLBI/NICHD 中心拨款（“FIT 家庭项目”，U01HL097889；PI-Naar）遵循国家心脏， 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 Families 与可靠的注意力控制相比的效果 FIT 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）都是根据文化量身定制的 并通过概念证明连续多重随机试验进行优化，使体重减轻 非洲裔美国青少年是一个庞大且未被充分研究的群体，一百八十名肥胖的非洲人。 12-17 岁的美国青少年及其主要照顾者将被随机分配到两个小组之一 治疗条件：1) FIT Families 或 2) Home-Based Family Support (HBFS) 注意力控制条件。 预计 FIT Families 将进一步降低青少年和看护者超重百分比， 增加体力活动以及使用基于证据的体重管理行为（自我 如果有效的话，FIT Families 是通过精心开发和改编的 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）通过解决非裔美国家庭及其家人的多种危险因素 因此，该项目对于潜在的公共卫生影响和影响具有重要意义。 减少肥胖相关的医疗费用。