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因肥胖和与肥胖有关的疾病而遭受不成比例的痛苦（例如， 西班牙裔/白色比例：与白人同行相比，糖尿病（1.7）。而行为减肥（WL） 干预措施是治疗肥胖症的第一行，它们的结局不同。大多数无法持久 影响，特别是在特定的种族/族裔亚组中。例如，黑人妇女的体重比她们的体重少50％ 即使参加了完全有能力的，精心设计的行为WL试验，白色对应物也是如此。一个合理 这些亚最佳结果的原因是仅在忽视个人层面上的行为改变 批判性的社会和环境力量。社交网络越来越被证明会影响健康 行为，但很少有针对体重减轻的研究，尤其是在种族/种族中 少数民族。响应PAS-20-160小R01，用于针对任务内疾病的临床试验 在NIDDK中，此应用将比较社交网络增强的生活方式干预（以下简称）的影响 被称为“强大”使用社会关系减少肥胖）到个人级别的生活方式干预（控制） 修改多个网络级别的障碍以减轻体重。我们将随机注册132个黑人或西班牙裔成年人 肥胖（BMI> 30 kg/m2），最多邀请两名社交网络成员 进行24周的多功能生活方式干预。我们将评估强大的干预措施是否不 仅解决个人水平的行为（即健康饮食，增加体育锻炼），但也：1）减少 通过激活公共应对来改变社会破坏以及改变感知的健康规范 - 行为 涉及思考，交流和行动的过程，好像健康风险（即2型糖尿病）共享； 2）通过教参与者的方式来抑制人际冲突增加对体重增加的有害影响 引起积极的影响和自我表达的心态，我们在先前的试验中已经显示（NHLBI-U01HL07843） 防止不必要的体重增加。控制臂的参与者将获得相同数量的生活方式会议 作为那些随机稳健的人。但是，他们的社交网络不会直接参与研究。我们 假设强大的干预将满足招聘的所有先验可行性/可接受性标准， 保留和研究行为。此外，强大的干预将导致多重变化 行为改变的障碍，导致更大比例的参与者经历改进 与对照组相比，在饮食，体育锻炼和体重减轻。如果被证明有效， 从这个小的RO1收集的初步数据将支持完全动力的RCT，这将导致优化 影响关键临床终点的多层次肥胖干预（即BMI，胰岛素抵抗和 人群中的血红蛋白A1C）与肥胖症及其代谢后遗症相关的不良预后风险。