Phase II (Intervention): Good Bowls: Empowering Communities to Achieve Good Food Access and Health Equity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 201
- 试验地点
- 2
- 主要终点
- Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score
研究概览
简要总结
The goal of this clinical trial is to improve the health of workers at their worksite by providing subsidized healthy meals supported by nutrition education and behavioral nudges using mobile health and Bluetooth technology.
The aim of this study is to:
Randomize 240 individuals in 8-10 worksites to either Good Bowls alone or Good Bowls + Phone App nudges. Using a crossover design, the primary outcome is the score on a validated Mediterranean diet screener, with secondary outcomes including weight, blood pressure, carotenoid levels, and food security.
Participants: Workers at blue and white-collar worksites.
Procedures: Workers will be recruited from 8-10 worksites who will be initially randomized within each site to Good Bowls alone or Good Bowls + Phone App nudges. Initial assignment will be followed for four months, after which the groups will crossover for the subsequent four months. The investigators will collect survey data as well as some physiologic measures including skin scanning (non-invasive), weight, and blood pressure. Effects between groups will be determined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Employed at participating worksite
- •No plans to move from the area for at least 1 year
- •Free living to the extent that participant has control over dietary intake
- •Willing and able to provide written informed consent and participate in all study activities
排除标准
- •Severe food allergies
- •Advanced kidney disease (estimated creatinine clearance < 30 ml/min)
- •Known psychosis or major psychiatric illness that prevents participation with study activities
- •Cognitive impairment, frailty, or other disability such that individual cannot fully participate in study activities
研究组 & 干预措施
Good Bowls + App Nudges, followed by Good Bowls alone
Participants in this arm will be exposed to Good Bowls + App Nudges throughout the first four months followed by four months of Good Bowls alone.
干预措施: Good Bowls (Behavioral)
Good Bowls + App Nudges, followed by Good Bowls alone
Participants in this arm will be exposed to Good Bowls + App Nudges throughout the first four months followed by four months of Good Bowls alone.
干预措施: Good Bowls + App Nudges (Behavioral)
Good Bowls, followed by Good Bowls + App Nudges
Participants in this arm will be exposed to Good Bowls alone throughout the first four months followed by four months of Good Bowls + App Nudges.
干预措施: Good Bowls (Behavioral)
Good Bowls, followed by Good Bowls + App Nudges
Participants in this arm will be exposed to Good Bowls alone throughout the first four months followed by four months of Good Bowls + App Nudges.
干预措施: Good Bowls + App Nudges (Behavioral)
结局指标
主要结局
Change in nutrition as measured by the Mediterranean Diet 14-Item Screener Score
时间窗: Baseline, 8 months
A slightly adapted version of the Mediterranean Diet 14-item validated screener will be used for nutritional assessment. The score ranges from 0-14, with a higher score indicating higher adherence to the Mediterranean Diet.
Mean Change in Nutrition as Measured by the Mediterranean Diet 14-Item Screener Score
时间窗: From enrollment to the end of the study at 8 months
A slightly adapted 14-item Mediterranean diet screener was used to assess adherence to a Mediterranean-style dietary pattern. Each item was scored 0 or 1, producing a total score ranging from 0 to 14, with higher scores indicating greater adherence. The outcome, mean change in score from the beginning of exposure to the treatment to the end of the exposure to the treatment, was calculated by first subtracting each participant's score at the start of exposure from their score at the end of exposure, and then by averaging the individual changes across all participants.
次要结局
- Change in skin carotenoids(Up to 8 months)
- Change in food security(Up to 8 months)
- Change in weight(Up to 8 months)
- Change in blood pressure(Up to 8 months)
- Mean Change in Weight(From enrollment to the end of the study at 8 months)
- Mean Change in Blood Pressure(From enrollment to the end of the study at 8 months)
- Mean Change in Skin Carotenoid Levels(From enrollment to the end of the study at 8 months)
- Change in Food Security(From enrollment to the end of the study at 8 months)