Multi-Level Trial of a Workplace Sales Ban of Sugary Beverages and Brief Motivational Counseling Intervention on Adiposity

工作场所销售含糖饮料禁令的多层次试验和肥胖的简短动机咨询干预

• 批准号: 10609047
• 负责人: Elissa S. Epel
• 金额: $ 61.4万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-15 至 2027-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10609047
• 关键词: Adopted; Adult; Alcohols; American; American diet; Attention; Behavior Therapy; Beverages; Blood; Blood specimen; Body mass index; California; Calories; Central obesity; Clinical Trials; Coffee; Consumption; Counseling; Cues; Data; Diabetes Mellitus; Dietary Assessment; Employee; Enrollment; Exposure to; Fruit; Health; Health Care Costs; Health Food; Health system; Healthcare Systems; Home; Hospitals; Hour; Incentives; Individual; Intake; Intervention; Investments; Knowledge; Lipids; Liquid substance; Low income; Magic; Mediating; Mediation; Metabolic; Metabolic Diseases; Modeling; Motivation; Non-Insulin-Dependent Diabetes Mellitus; Obesity; Occupational Status; Outcome; Participant; Pilot Projects; Policies; Prevention; Public Health; Randomized; Randomized, Controlled Trials; Research; Risk; Risk Factors; Role; Sales; Schools; Science; Self Administration; Serum; Site; Source; Sports; Tea; Testing; Tobacco; Work; Workplace; behavior change; brief intervention; cost; craving; dietary; drinking; effectiveness evaluation; ethnic minority; experience; food environment; high risk; high risk population; improved; insulin sensitivity; obesity prevention; primary outcome; programs; randomized trial; remote assessment; remote delivery; secondary outcome; soft drink; sugar; sweetened beverage; synergism; therapy design; waist circumference

ABSTRACT Sugar-sweetened beverages (SSBs, e.g., sodas, sports drinks, “fruit” drinks, bottled teas, coffees) have emerged as a key dietary risk factor for obesity and type 2 diabetes. We propose a double-randomized controlled trial of a multilevel workplace intervention that combines an employer-sponsored sales ban on SSBs with brief motivational counseling to support reduced consumption. Health systems and schools are increasingly adopting sales bans of SSBs and replacing them with healthier options. Employer-based brief counseling interventions, despite being low-cost and highly efficacious for alcohol and tobacco reduction, have received limited attention as a strategy to reduce SSB consumption. A multilevel intervention combining both strategies may be the most effective: the brief counseling intervention can increase motivation to reduce SSBs despite cravings while the sales ban removes SSB-related availability and cues from the workplace. Our pilot data strongly support the rationale for combining these interventions and for the mediating role of SSB cravings. The proposed trial tests this multilevel intervention, called the workplace Metabolic Health Improvement Program (MHIP), in partnership with a Northern California-based academic healthcare system, Sutter Health (enrolling N=700 employees on N=16 hospital campuses). The first randomization will assign hospital campuses to the employer-sponsored sales ban on SSBs (8 sites) versus control (8 sites). The second randomization will assign employees to the brief counseling intervention versus control, split equally across sales ban and control sites. We assess anthropometrics and blood at baseline and 12 months. The primary outcome is change in central obesity (e.g., waist circumference). Secondary outcomes include changes in SSB consumption, Body Mass Index (BMI), serum insulin sensitivity (homeostatic model assessment [HOMA]), and lipids. Dietary and beverage composition is assessed remotely using the Automated Self-Administered 24- Hour recall (ASA-24) at baseline, 6 and 12 months. The first aim of this research is to assess the independent effects of the brief counseling intervention and workplace SSB sales ban on changes in primary and secondary outcomes. The second aim is to test the multilevel effects of combining the brief intervention and SSB sales ban on outcomes. A third, exploratory aim examines whether reductions in SSB cravings mediate the effects of the multilevel intervention on outcomes. If effective, the employer-sponsored multilevel intervention will offer an efficient, scalable strategy for preventing obesity and metabolic disease in millions of American working adults.

摘要 含糖饮料(SSB，例如汽水、运动饮料、水果饮料、瓶装茶、咖啡) 成为肥胖和2型糖尿病的关键饮食风险因素。我们提出了一种双重随机的 结合雇主赞助的对SSB的销售禁令的多级工作场所干预的对照试验 通过简短的激励咨询来支持减少消费。卫生系统和学校 越来越多地采用SSB的销售禁令，并以更健康的选择取而代之。基于雇主的简介 咨询干预，尽管在减少酒精和烟草方面成本低，效果很好，但 作为减少SSB消费的一项战略，受到的关注有限。将两者结合在一起的多层次干预 策略可能是最有效的：短暂的咨询干预可以增加减少SSB的动力 尽管销售禁令消除了与SSB相关的供应和工作场所的线索，但人们对SSB的渴望仍然存在。我们的飞行员 数据有力地支持了将这些干预措施结合在一起以及SSB发挥调解作用的理由 渴望。 这项拟议的试验测试了这种多层次的干预，称为工作场所新陈代谢健康改善 计划(MHIP)，与总部位于北加州的学术医疗保健系统Sutter Health合作 (在N=16个医院园区招收N=700名员工)。第一次随机分配将分配医院 雇主赞助的SSB销售禁令(8个站点)与对照(8个站点)的校园。第二 随机化将员工分配到短暂的咨询干预和对照中，平均分配 销售禁令和管制网站。我们在基线和12个月时评估人体测量学和血液。初级阶段 结果是中心性肥胖的变化(例如，腰围)。次要结果包括SSB的变化 消耗量、体重指数(BMI)、血清胰岛素敏感性(稳态模型评估[HOMA])，以及 脂类。使用24小时自动给药系统远程评估饮食和饮料成分。 在基线、6个月和12个月时进行小时回忆(ASA-24)。 本研究的第一个目的是评估短期咨询干预的独立效果。 和工作场所SSB销售禁令，禁止改变主要和次要结果。第二个目标是测试 短期干预和SSB销售禁令相结合对结果的多层面影响。第三，探索性目标 研究SSB渴望的降低是否在多水平干预对结果的影响中起到中介作用。 如果有效，雇主赞助的多级干预将为以下方面提供一种高效、可扩展的战略 预防数百万美国在职成年人的肥胖和代谢性疾病。