Multi-Level Trial of a Workplace Sales Ban of Sugary Beverages and Brief Motivational Counseling Intervention on Adiposity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Change in Abdominal Adiposity (Waist Circumference)
研究概览
简要总结
The purpose of the study is to test the impact of a multilevel workplace intervention (hospital-wide sales ban on sugar-sweetened beverages (SSBs) and individual-level brief counseling) on employee health.
详细描述
This double-randomized controlled trial of a multilevel workplace intervention that combines an employer-sponsored sales ban on sugar-sweetened beverages (SSBs) with brief counseling to support reduced consumption will test how well each intervention works alone, whether they work better in combination than separately, and whether or not changes in SSB cravings mediate these effects. Sutter Health worksites will be randomly assigned to either a control condition or to implement a sales ban on SSBs. Within all sites, employees will be randomized to receive/not receive a brief counseling intervention focused on reducing SSB consumption. Participants will complete self-report questionnaires, give blood samples, and provide measurements of waist circumference, height, and weight. These data will be analyzed to determine the effects of the interventions, both separately and in combination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The study is a double-randomized, controlled trial of 700 Sutter Health employees working at 16 hospital campuses. The hospital campuses will be randomized to sales ban or control. After screening employees at the 16 campuses for heavy SSB consumption (> 30 oz/week), the investigators will further randomize study participants to receive the brief counseling intervention or not.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Full-time employee who works on campus at one of the Sutter Health participating sites
- •Speaks and reads English
- •Consumes three or more sugar-sweetened beverages (SSB) a week
- •Agrees to participate in two fasting blood draws
排除标准
- 未提供
研究组 & 干预措施
Control: No workplace SSB sales ban, no brief intervention
Participants receive no workplace SSB sales ban (environmental intervention) and no brief counseling intervention.
Workplace SSB sales ban only
Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options.
干预措施: Workplace SSB sales ban (Other)
Brief intervention only
Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.
干预措施: Brief Intervention (Behavioral)
Multilevel Intervention (workplace SSB sales ban + brief intervention)
Sales ban: Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options.
Brief Intervention: Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.
干预措施: Workplace SSB sales ban (Other)
Multilevel Intervention (workplace SSB sales ban + brief intervention)
Sales ban: Participants receive a workplace SSB sales ban (environmental intervention). This entails the removal of SSBs from all workplace sales outlets, replacing them with non-sugary beverage options.
Brief Intervention: Participants receive a 20-30 minute intervention by video call, with 2 booster telephone calls. One week and one month after the initial session, participants will have 10-minute check-in/booster phone calls.
干预措施: Brief Intervention (Behavioral)
结局指标
主要结局
Change in Abdominal Adiposity (Waist Circumference)
时间窗: Baseline and 12 Months
Waist circumference in centimeters (using method from Multi-Ethnic Study of Atherosclerosis). The study will measure the change between baseline and 12 month Abdominal Adiposity measurements.
Change in Insulin Sensitivity (HOMA)
时间窗: Baseline and 12 Months
Insulin sensitivity will be calculated using the homeostatic model assessment (HOMA). The equation for HOMA is fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. The study will measure the change between baseline and 12 month HOMA.
次要结局
- Change in Lipid Profile Measurements(Baseline and 12 Months)
- Change in Fasting Glucose Levels(Baseline and 12 Months)
- Change in Quantity of SSB Consumption(Baseline and 12 Months)
- Change in Body Mass Index (BMI)(Baseline and 12 Months)
- Change in ApoB Levels(Baseline and 12 Months)
- Change in Fasting insulin Levels(Baseline and 12 Months)