Brighter Bites & University of Texas Physicians Produce Rx: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in alanine aminotransferase (ALT)
研究概览
简要总结
The purpose of this study is to clinically evaluate the effectiveness of an at-home produce delivery prescription or grocery store vouchers prescription at improving weight status and obesity-related health outcomes of participants across the two clinics as compared to a control group and to examine the impacts of the program on child dietary behavioral outcomes (child fruit and vegetable intake, junk food consumption, and eating at any type of restaurant), and parent feeding practices (preparing foods from scratch, use of nutrition facts labels to make purchasing decisions, and eating meals with their referent child)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •reside within a 10-mile radius of a Brighter Bites school
- •Medicaid recipients or low-income uninsured
- •parents must be able to read and write in English or Spanish to complete surveys
排除标准
- •currently participating in Brighter Bites
- •with a family member/sibling currently participating in Brighter Bites
- •child is currently attending a school that offers Brighter Bites
结局指标
主要结局
Change in alanine aminotransferase (ALT)
时间窗: Baseline, 9 months after baseline
Change in hemoglobin A1c
时间窗: Baseline, 9 months after baseline
Change in Aspartate transaminase (AST)
时间窗: Baseline, 9 months after baseline
Change in Body Mass Index (BMI)
时间窗: Baseline, 9 months after baseline
Change in systolic blood pressure
时间窗: Baseline, 9 months after baseline
Change in Lipid panel
时间窗: Baseline, 9 months after baseline
Change in diastolic blood pressure
时间窗: Baseline, 9 months after baseline
次要结局
- Change in amount of fruit and vegetable intake(Baseline, 9 months after baseline)
- Change in number of times subject eats out at restaurants(Baseline, 9 months after baseline)
- Change in amount of junk food consumed(Baseline, 9 months after baseline)
- Change in parent feeding practices as assessed by the number of times parent has used nutrition facts labels to make purchasing decisions(Baseline, 9 months after baseline)
- Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child(Baseline, 9 months after baseline)
- Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch(Baseline, 9 months after baseline)
研究者
Christine Markham
Professor
The University of Texas Health Science Center, Houston