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临床试验/NCT05869149
NCT05869149招募中不适用

Systems Science Approaches to Improve Access to Healthier Foods: The FRESH Trial

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 756 人开始时间: 2023年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
756
试验地点
2
主要终点
Change in Customer Dietary Quality

研究概览

简要总结

Working with independently owned restaurants, a common source of calorie-rich, nutrient-poor foods in predominantly minority, low-income urban neighborhoods, has the potential to improve dietary quality, and contribute to cancer prevention. This study uses systems science approaches to improve access to healthier foods in independently owned restaurants by: 1) testing the effects of a novel intervention called FRESH (Focus on Restaurant Engagement to Strengthen Health) on dietary quality, health indicators and other outcomes in African American and Latin communities, and 2) developing a system dynamics model to allow stakeholders to virtually test FRESH strategies in their own communities. The resulting restaurant intervention simulation model offers potential cost savings from avoided trial-and-error testing, and will support community-based cancer prevention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult (18-75 years)
  • Regular restaurant customer (e.g., visits the specified restaurant at least 1x/week)
  • Live in a household of at least 2 persons (criterion intended to provide a more stable sample, and to reduce loss to follow-up)
  • Current resident of study neighborhood

排除标准

  • Anticipate moving out of Baltimore or District of Columbia metropolitan area in the next 18 months
  • Pregnant (due to changes in diet, weight and body composition)

研究组 & 干预措施

Restaurants receiving FRESH intervention

Experimental

Restaurants enrolled in the experimental arm of will FRESH undergo activities aimed to improve their healthy food offerings at their restaurants.

干预措施: Multilevel restaurant intervention to improve the food environment (Behavioral)

Restaurants not receiving FRESH intervention

No Intervention

Restaurants will be enrolled in the study, but not receive the FRESH intervention.

结局指标

主要结局

Change in Customer Dietary Quality

时间窗: 1 hour, 24 months apart

Regular customer diet quality in the last 30 days will be assessed using the 2014 semi-quantitative Block Food Frequency Questionnaire (FFQ). The FFQ provides the data that allows for calculating the Healthy Eating Index. We will use the 2015 index rules. Healthy Eating Index (HEI) 2015 Score and individual component scores will be calculated from the FFQ according to the HEI-2015 guidelines to assess changes in overall diet quality and changes within each component. The range of scores for the Healthy Eating Index 2015 is 0-100. A higher score is considered better and represents meeting more of the recommended dietary guidelines.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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