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

摘要：儿童和成人的肥胖率令人震惊，特别是在少数民族中， 被国家卫生研究院确定为面临的最严重的公共卫生挑战之一 21世纪的我们的国家。南卡罗来纳州是“中风带”的一部分，肥胖率位居第三 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%，位居第12位。不幸的是， 南卡罗来纳州的非裔美国人超重或肥胖的可能性更大(75.7%的成年人，40%的人 儿童)，这使他们处于与肥胖相关的疾病的相当高的风险中，如哮喘、2型 糖尿病、心血管疾病、高血压、中风和某些形式的癌症。这一公共卫生挑战 由于缺乏专门为满足以下人群的独特需求而量身定做的干预战略，这一点更加复杂 少数民族。这项R01随机临床试验由最近完成的一项研究结果提供信息 NHLBI/NICHD中心赠款(Fit Families Project，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(ORBLE)模型的开发 行为干预，将与可信的注意力控制相比较，检验适合家庭的有效性。 条件。FIT家庭的四个基于证据的行为组成部分中的每一个(基于家庭的服务， 应急管理、激励性访谈、认知行为技能培训)是根据文化量身定做的 并通过一项概念验证多重随机试验进行优化，该试验在 非裔美国青少年，一个庞大而未被充分研究的群体。180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组中的一组 治疗条件：1)健康家庭或2)家庭支持(HBFS)注意控制条件。它 据预测，健康的家庭将大大减少青少年和照顾者超重的百分比， 以及增加体力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，适合家庭，这是经过精心开发和调整的 轨道的连续阶段，有可能减少肥胖相关疾病的差异 (心血管和代谢)通过解决非裔美国人家庭及其 青春期儿童。因此，该项目在潜在的公共卫生影响和 减少与肥胖相关的医疗成本。

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.