Brighter Bites & Legacy Community Health Produce Rx: Evaluating the Feasibility and Effectiveness of a School-based Clinical Nutrition Program With Produce Prescription
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Change in systolic blood pressure
研究概览
简要总结
The purpose of this study is to assess the effectiveness of the produce prescription program at improving weight status and obesity-related health outcomes of participants, to examine the impacts of the program on household food insecurity and nutrition security, to examine the impacts of the program on participating adolescents' dietary behavioral outcomes, their home nutrition environment and feeding practices and to examine the impacts of the program in reducing healthcare use and associated costs
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be a patient at one of the four Legacy Community Health School-based clinics in Galena Park, Texas
- •BMI greater than or equal to 85th percentile
- •reside within a 10-mile radius of Houston Food Bank
- •Medicaid recipients or low-income uninsured
- •parents must be able to read and write in English or Spanish to complete surveys
- •patient and parents must confirm their willingness to complete the participant's well-child visit for the entire period of the study (approximately one year).
排除标准
- •currently participating in Brighter Bites
- •with a family member/sibling currently participating in Brighter Bites
结局指标
主要结局
Change in systolic blood pressure
时间窗: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
Change in hemoglobin A1c as assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
Change in body mass index (BMI)
时间窗: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
Change in lipid panels assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
Change in diastolic blood pressure
时间窗: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
Change in Aspartate transaminase (AST) assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
Change in Alanine transaminase (ALT) assessed by blood work
时间窗: baseline , post intervention (32 weeks after baseline)
This will be collected from chart reviews as these measures are routinely collected for all pediatric patients in this weight classification based on the American Association of Pediatric recommendations.
次要结局
- Change in household food insecurity as assessed by the U.S. Household Food Security Survey Module: Six-Item Short Form Economic Research Service(baseline , post intervention (32 weeks after baseline))
- Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener(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 amount of junk food consumed(baseline , post intervention (32 weeks after baseline))
- Healthcare usage as assessed by the number of well-visits(post intervention (32 weeks after baseline))
- Healthcare usage as assessed by the number of no shows to clinic appointments(From 6 months prior to the intervention to two months post-intervention)
- Change in amount of fruit and vegetable intake(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))
- Healthcare usage as assessed by the number of visits due to illness(post intervention (32 weeks after baseline))
- Change in household food insecurity prevalence among participants (measured as a percentage) as assessed by the two item Hunger Vital Sign screening tool(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))
- 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 impact of the Produce Prescription intervention on adolescent patients' behavioral and emotional health as assessed by the Patient Health Questionnaire for Adolescents (PHQ-A)(baseline , post intervention (32 weeks after baseline))
研究者
Ru-Jye Chuang
Assistant Professor
The University of Texas Health Science Center, Houston