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.

抽象的 含糖饮料（SSB，例如苏打水、运动饮料、“水果”饮料、瓶装茶、咖啡） 已成为肥胖和 2 型糖尿病的关键饮食危险因素。我们建议采用双随机 多层次工作场所干预的对照试验，其中结合了雇主资助的 SSB 销售禁令 通过简短的动机咨询来支持减少消费。卫生系统和学校 越来越多地采用 SSB 销售禁令，并用更健康的选择取而代之。基于雇主的简介 尽管咨询干预措施成本低且对减少酗酒和吸烟非常有效，但 作为减少 SSB 消耗的策略，受到的关注有限。结合两者的多层次干预 策略可能是最有效的：简短的咨询干预可以增加减少 SSB 的动力 尽管有渴望，但销售禁令消除了工作场所中与 SSB 相关的可用性和线索。我们的飞行员 数据有力地支持了结合这些干预措施以及 SSB 的中介作用的基本原理 渴望。 拟议的试验测试了这种多层次的干预措施，称为工作场所代谢健康改善 计划 (MHIP)，与北加州学术医疗保健系统 Sutter Health 合作 （在 N=16 个医院园区招募 N=700 名员工）。第一次随机分组将分配医院 校园对雇主发起的 SSB（8 个站点）销售禁令与控制（8 个站点）的影响。第二个 随机化将分配员工进行简短的咨询干预与控制，平均分配 销售禁令和控制网站。我们评估基线和 12 个月时的人体测量学和血液。初级 结果是中心性肥胖（例如腰围）的变化。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]）和 脂质。使用自动自我管理 24 小时远程评估饮食和饮料成分 基线、6 个月和 12 个月时的小时回忆 (ASA-24)。 本研究的首要目的是评估简短咨询干预的独立效果 和工作场所 SSB 销售禁令改变主要和次要结果。第二个目的是测试 短期干预和 SSB 销售禁令相结合对结果产生多层次的影响。第三个，探索性目标 研究了 SSB 渴望的减少是否介导了多层次干预对结果的影响。 如果有效，雇主资助的多层次干预措施将为企业提供高效、可扩展的战略。 预防数百万美国职业成年人的肥胖和代谢疾病。