Brighter Bites/Legacy Produce Rx Program

Официальное название

Brighter Bites & Legacy Community Health Produce Rx: Evaluating the Feasibility and Effectiveness of a School-based Clinical Nutrition Program With Produce Prescription

Обзор

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

Вмешательства

• Другое Produce Prescription Group
  Participants will receive 16 produce bags, each containing approximately 50 servings of F\&V. The produce bags will be assembled by Brighter Bites at school sites using donated produce and delivered to houses using DoorDash. F\&V bags will be distributed to families every 2 weeks for 16 distributions (over approximately 32 weeks). Participants will also receive nutrition education, including MyPlate.gov's Start Simple App for adolescents, and a Virtual Culinary Medicine Program for parents; thes
• Другое Control Group
  Participants in this group will be selected from de-identified Electronic Health Record (EHR) provided by Legacy Community Health with a 1-to-1 match to the intervention group participant's demographic characteristics and Medicaid eligibility.

Первичные конечные точки

• Change in body mass index (BMI) [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in systolic blood pressure [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in diastolic blood pressure [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in hemoglobin A1c as assessed by blood work [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in Aspartate transaminase (AST) assessed by blood work [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in Alanine transaminase (ALT) assessed by blood work [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in lipid panels assessed by blood work [Срок оценки: baseline , post intervention (32 weeks after baseline)]

Вторичные конечные точки (12)

• Change in household food insecurity prevalence among participants (measured as a percentage) as assessed by the two item Hunger Vital Sign screening tool [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in household food insecurity as assessed by the U.S. Household Food Security Survey Module: Six-Item Short Form Economic Research Service [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in nutrition security as assessed by the self reported Perceived Limited Ability validated screener [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in amount of fruit and vegetable intake [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in amount of junk food consumed [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Change in number of times subject eats out at restaurants [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: baseline , post intervention (32 weeks after baseline)]
• Healthcare usage as assessed by the number of well-visits [Срок оценки: post intervention (32 weeks after baseline)]
• Healthcare usage as assessed by the number of visits due to illness [Срок оценки: post intervention (32 weeks after baseline)]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• currently participating in Brighter Bites
• with a family member/sibling currently participating in Brighter Bites

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas Health Science Center at Houston — Houston

Идентификаторы

NCT: NCT06407284 · HSC-SPH-23-0850

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗