Reducing Obesity Using Social Ties (ROBUST)

利用社会关系减少肥胖（稳健）

基本信息

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
项目类别：
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

项目摘要

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不成比例地患有肥胖和肥胖相关疾病（例如，西班牙裔/白人比例：糖尿病（1.7）与白腿相比，而行为体重减轻（WL）。干预措施是治疗肥胖的第一线，但大多数措施都未能取得持久的效果。影响，特别是在特定种族/民族亚群体中，例如，黑人女性的体重比她们少 50%。白人同事，即使参加了功能齐全、设计良好的行为 WL 试验。这些次优结果的原因是只关注个人层面的行为改变，而忽视了越来越多的证据表明，社交网络对健康有影响。行为，但它们很少被用于针对减肥的研究，特别是在种族/族裔中响应任务内针对疾病的临床试验 PAS-20-160 小 R01。 NIDDK 的该应用程序将比较社交网络增强生活方式干预的效果（以下简称被称为“稳健”减少肥胖（利用社会关系）的个人水平生活方式干预（控制）修改多个网络层面的减肥障碍我们将随机招募 132 名黑人或西班牙裔成年人。患有肥胖症（BMI > 30 kg/m2）并邀请最多两名 ROBUST 组参与者的社交网络成员我们将评估稳健的干预措施是否不可行。仅解决个人层面的行为（即健康饮食、增加体力活动），而且：1) 减少通过激活公共应对措施（一种行为）来破坏社会并改变感知的健康规范涉及思考、沟通和行动的过程，就像共同承担健康风险（即 2 型糖尿病）一样； 2）通过教导参与者如何减少人际冲突增加对体重的有害影响诱导积极的情感和自我肯定的心态，我们在之前的试验中已经证明了这一点 (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课程。但是，他们的社交网络不会直接参与这项研究。具体来说，稳健的干预措施将满足招募的所有先验可行性/可接受性标准，此外，稳健的干预措施将在多个方面带来积极的变化。行为改变的障碍，导致更大比例的体验改善与对照组相比，24 周时的饮食、体力活动和体重减轻情况如果被证明有效，从这个小型 RO1 收集的初步数据将支持全功率 RCT，从而产生优化的结果影响关键临床终点（即体重指数、胰岛素抵抗和血红蛋白 A1c）存在于与肥胖及其代谢后遗症相关的不良结果风险极高的人群中。