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: 10467924
• 负责人: Elissa S. Epel
• 金额: $ 66.98万
• 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/10467924
• 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; Employee; Enrollment; Exposure to; Fruit; Health; Health Care Costs; Health Food; Health system; Healthcare Systems; Home; Hospitals; Hour; Incentives; Individual; Intake; Intervention; 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; base; behavior change; brief intervention; cost; craving; dietary; drinking; effectiveness evaluation; ethnic minority; experience; food environment; high risk; high risk population; insulin sensitivity; obesity prevention; primary outcome; programs; randomized trial; 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，苏打水、运动饮料、“水果”饮料、瓶装茶、咖啡）具有 成为肥胖和2型糖尿病的关键饮食风险因素。我们提出了一个双随机 一项多层次工作场所干预的对照试验，该干预结合了雇主赞助的对SSB的销售禁令 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的销售禁令，并以更健康的选择取代它们。基于雇主的简报 咨询干预，尽管是低成本和高度有效的酒精和烟草减少， 作为减少SSB消耗的战略，受到的关注有限。多层次的干预措施， 策略可能是最有效的：简短的咨询干预可以增加减少SSB的动机 尽管渴望，而销售禁令消除了SSB相关的可用性和线索，从工作场所。我们的飞行员 数据有力地支持了将这些干预措施结合起来以及单边带的中介作用的理论基础 渴望 拟议的试验测试这种多层次的干预，称为工作场所代谢健康改善 计划（MHIP），与北方加利福尼亚州的学术医疗保健系统，萨特健康合作 （在N=16个医院园区招募N=700名员工）。首次随机化将分配医院 与对照组（8个地点）相比，雇主赞助的销售禁令对SSB（8个地点）。第二 随机化将员工分配到简短的咨询干预和控制，平均分配到 销售禁令和控制网站。我们在基线和12个月时评估人体测量学和血液。主 结果是中心性肥胖的改变（例如，腰围）。次要结局包括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 脂质。饮食和饮料成分使用自动自助24- 基线、6个月和12个月时的小时回忆（阿萨-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销售禁令的主要和次要结果的变化。第二个目标是测试 结合短期干预和SSB销售禁令对结果的多层次影响。第三个是探索性的目标 检查是否减少SSB的渴望介导的影响，多层次的干预结果。 如果有效，雇主赞助的多层次干预将提供一个有效的，可扩展的战略， 预防肥胖和代谢性疾病在数百万美国工作的成年人。