Reducing Obesity Using Social Ties (ROBUST)

利用社会关系减少肥胖（稳健）

• 批准号: 10638585
• 负责人: Erica Phillips
• 金额: $ 30.64万
• 依托单位: WEILL MEDICAL COLL OF CORNELL UNIV
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-06-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10638585
• 关键词: Address; Adoption; Adult; Affect; Asian population; Behavior; Behavioral; Black race; Body Weight Changes; Body Weight decreased; Body mass index; Characteristics; Clinical; Clinical Trials; Communication; Control Groups; Data; Diabetes Mellitus; Diet; Diffusion; Disease; Educational process of instructing; Enrollment; Environmental Risk Factor; Ethnic Population; Failure; Family; Feasibility Studies; Friends; Glycosylated hemoglobin A; Goals; Health; Health behavior; Healthy Eating; Hispanic; Home; Individual; Insulin Resistance; Intervention; Intervention Studies; Knowledge; Life Style; Link; Literature; Measurement; Measures; Metabolic; Mission; National Heart, Lung, and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; Obesity; Outcome; Participant; Pattern; Persons; Phenotype; Physical activity; Population; Process; Race; Randomized; Randomized, Controlled Trials; Recurrence; Risk; Secondary to; Social Environment; Social Network; Social support; Structure; Testing; Thinking; Time; Weight; Weight Gain; adult obesity; arm; behavior change; black women; commune; comparison control; coping; design; ethnic minority; ethnic minority population; experience; good diet; high risk; high risk population; improved; interpersonal conflict; intervention effect; lifestyle intervention; member; neglect; obesity risk; obesity treatment; prevent; primary outcome; promote resilience; prospective; racial minority; racial minority population; recruit; response; social; social factors; social norm; weight loss intervention

Black and Hispanic adults suffer disproportionately from obesity and obesity-related conditions (e.g., Hispanic/White ratio: diabetes (1.7) compared to their white counterparts. While behavioral weight loss (WL) interventions are the first line in treating obesity, they have mixed outcomes. Most fail to make a persistent impact, especially in specific racial/ethnic subgroups. For example, Black women lose 50% less weight than their white counterparts, even when enrolled in fully powered, well-designed behavioral WL trials. One plausible reason for these sub-optimal results is a focus on behavior change at the individual level alone while neglecting critical social and environmental forces. Social networks have been increasingly shown to influence health behaviors, yet they have seldom been harnessed in studies targeting weight loss, especially among racial/ethnic minorities. In response to PAS-20-160 Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK, this application will compare the effects of a social-network enhanced lifestyle intervention (hereafter termed "ROBUST" Reducing OBesity Using Social Ties) to an individual level lifestyle intervention (control) on modifying multiple network-level barriers to weight loss. We will randomly enroll 132 Black or Hispanic adults with obesity (BMI > 30 kg/m2) and invite up to two social network members of participants in the ROBUST arm to a 24 –week multi-competent lifestyle intervention. We will evaluate whether the ROBUST intervention not only addresses individual-level behaviors (i.e., healthy eating, increased physical activity) but also: 1) reduces social undermining as well as changes perceived health norms by activating communal coping - a behavioral process that involves thinking, communicating, and acting as if a health risk (i.e., Type 2 diabetes) is shared; and 2) dampens the harmful effects of increased interpersonal conflict on weight by teaching participants how to induce a positive affect and self-affirming mindset which we have shown in a previous trial (NHLBI-U01HL07843) prevents unwanted weight gain. Participants in the control arm will receive the same number of lifestyle sessions as those randomized to ROBUST. But, their social network will not be directly engaged in the study. We hypothesize that the ROBUST intervention will satisfy all a priori feasibility/acceptability criteria for recruitment, retention, and study conduct. Additionally, the ROBUST intervention will result in positive changes in multiple barriers to behavior change, leading to a more significant proportion of participants experiencing improvements in diet, physical activity, and weight loss at 24 weeks compared to the control group. If proven effective, the preliminary data gathered from this small RO1 will support a fully powered RCT that will result in an optimized multi-level obesity intervention that impacts critical clinical endpoints (i.e., BMI, insulin resistance, and hemoglobin A1c) in a population at very high risk of poor outcomes related to obesity and its metabolic sequelae.

黑人和西班牙裔成年人患有肥胖症和肥胖相关疾病的比例更高(例如， 西班牙裔/白人比例：糖尿病(1.7)，而白人为1.7%。而行为减肥(WL) 干预措施是治疗肥胖症的第一线，它们的结果好坏参半。大多数人没有做出持之以恒的 影响，特别是在特定的种族/民族分组中。例如，黑人女性减掉的体重比她们 白人同行，即使在全功率、精心设计的行为WL试验中也是如此。一件看似合理的事 这些次优结果的原因是只关注个人层面的行为变化，而忽视了 关键的社会和环境力量。越来越多的证据表明，社交网络会影响健康 行为，但很少在针对减肥的研究中利用它们，特别是在种族/民族中 少数族裔。回应针对特派团内疾病的临床试验的PAS-20-160小型R01 对于NIDDK，这个应用程序将比较社交网络增强的生活方式干预的效果(以下简称 从个人层面的生活方式干预(控制)到使用社会纽带“有力地”减少肥胖 修改多个网络级别的减肥障碍。我们将随机招收132名黑人或西班牙裔成年人 肥胖(BMI&GT；30公斤/平方米)，并邀请最多两名社交网络成员参加健壮的手臂 进行为期24周的多种能力的生活方式干预。我们将评估强有力的干预是否 只解决个人层面的行为(即健康饮食、增加体力活动)，但也：1)减少 通过激活社区应对来破坏社会以及改变感知的健康规范--一种行为 涉及思考、沟通和行动的过程，就像分担了健康风险(即2型糖尿病)一样； 2)通过教参与者如何减少增加的人际冲突对体重的有害影响 诱导积极的情感和自我肯定的心态，这是我们在之前的试验中表现出来的(NHLBI-U01HL07843) 防止不必要的体重增加。控制组的参与者将接受相同数量的生活方式会话 因为那些随机到稳健的。但是，他们的社交网络不会直接参与这项研究。我们 假设强有力的干预将满足招聘的所有先验可行性/可接受性标准， 留存，和学习行为。此外，强有力的干预将导致多个方面的积极变化 行为改变的障碍，导致更多的参与者体验到改善 在饮食、体力活动和体重减轻24周时与对照组进行比较。如果证明是有效的， 从这一小RO1收集的初步数据将支持全功率RCT，从而实现优化的 影响关键临床终点的多层次肥胖干预(即BMI、胰岛素抵抗和 在与肥胖及其代谢后遗症相关的不良结局风险非常高的人群中。