Brighter Bites & University of Texas Physicians Produce Rx Extension: Evaluating the Effectiveness of a Prospective Clinical Nutrition Study With Produce Prescriptions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Change in level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work
研究概览
简要总结
The purpose of this study is to clinically evaluate the effectiveness of an at-home delivery produce prescription in improving weight status and obesity-related health outcomes 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
- •Must be a patient at University of Texas Physicians Greens Clinic or University of Texas Physicians Pediatric Primary Care in Houston, Texas
- •BMI>85th percentile
- •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
- •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 level of hemoglobin A1c in milligrams per deciliter (mg/dL) as assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
Change in level of Aspartate transaminase (AST) in units per liter (U/L) as assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
Change in level of Alanine transaminase (ALT) in units per liter (U/L) as assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
Change in systolic blood pressure
时间窗: baseline , post intervention (32 weeks after baseline)
Change in levels of triglycerides in milligrams per deciliter (mg/dl) as assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
Change in body mass index (BMI)
时间窗: baseline , post intervention (32 weeks after baseline)
Change in diastolic blood pressure
时间窗: baseline , post intervention (32 weeks after baseline)
Change in level of low-density lipoprotein(LDL) in milligrams per deciliter (mg/dl) as assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
Change in levels of high-density lipoprotein(HDL) in milligrams per deciliter (mg/dl) as assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
Change in levels of total cholesterol in milligrams per deciliter (mg/dl) as assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
次要结局
- Change in parent feeding practices as assessed by the number of times parent has eaten meals with their referent child(baseline , post intervention (32 weeks after baseline))
- Change in amount of fruit and vegetable intake(baseline , post intervention (32 weeks after baseline))
- Change in amount of junk food consumed(baseline , post intervention (32 weeks 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 , post intervention (32 weeks after baseline))
- Change in number of times subject eats out at restaurants(baseline , post intervention (32 weeks after baseline))
- Change in parent feeding practices as assessed by the number of times parent has cooked food from scratch(baseline , post intervention (32 weeks after baseline))
研究者
Shreela V Sharma
Professor
The University of Texas Health Science Center, Houston