Evaluating the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Child and Parents Health in a Persistent Poverty Area

Официальное название

Cluster-Randomized Controlled Trial (RCT) to Evaluate the Impact of a School-based Fruit and Vegetable Co-op on Cardiometabolic Health of Children and Parents in a Persistent Poverty Area

Обзор

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to a wait-list control group 9 months after the intervention on changes in primary child outcomes (HbA1c, and vegetable intake), on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)), and the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes.

Подробное описание

The purpose of this study is to examine the effects of the (Brighter Bites (BB) intervention compared to wait-list control at post intervention on changes in primary child outcomes (HbA1c, and vegetable intake), to examine the effects of the BB intervention compared to wait-list control at 9-month post intervention on changes in secondary outcomes (household food security status, parent and child dietary behaviors, and home access/availability of fruits and vegetables (FV)),to examine the mediational influence of changes in food security status, parent outcomes, and home environment measures on changes in child outcomes at 9-month post-intervention, using within-subject analyses, examine and compare the long-term and dose-response effects of the BB intervention strategies on diet, adiposity, and metabolic outcomes at 21-month follow-up in the children and to explore the moderating effects of social and environmental variables on program effectiveness.

Вмешательства

• Другое Brighter Bites
  Families will receive a distribution of fresh fruits and vegetables (FV) (\~20lbs., 50 servings/family/distribution) for \~16 weeks during the school year using primarily donated produce from local food banks. Nutrition education will be implemented for children using the evidence-based Coordinated Approach to Child Health (CATCH) program and for parents using bilingual nutrition handbooks and fun food experiences such as healthy FV recipe tastings for families during produce pick-up time will b

Первичные конечные точки

• Change in level of child Glycosylated hemoglobin (HbA1c) [Срок оценки: baseline, post intervention (9 months after baseline)]
• Change in amount of child vegetable intake as assessed by the VEGGIE METER® [Срок оценки: baseline, post intervention (9 months after baseline)]

Вторичные конечные точки (8)

• Change in household food security status as assessed by a parent survey [Срок оценки: baseline, post intervention (9 months after baseline)]
• Number of servings consumed by the parent as assessed by the Adapted Health of Houston Survey (HHS) on processed food/drinks 4-items, and fruit and vegetable intake 2 items. [Срок оценки: baseline, post intervention (9 months after baseline)]
• Number of servings consumed by the Child as assessed by the NIH's Eating at America's Table questionnaire (All Day) and the Dietary Screener Questionnaires [Срок оценки: baseline, post intervention (9 months after baseline)]
• Child systolic blood pressure [Срок оценки: baseline]
• Child systolic blood pressure [Срок оценки: Post intervention (9 months after baseline)]
• Child diastolic blood pressure [Срок оценки: baseline]
• Child diastolic blood pressure [Срок оценки: post intervention (9 months after baseline)]
• Change in home access/availability of fruits and vegetables as assessed by the Nutrition security measures questionnaire [Срок оценки: baseline, post intervention (9 months after baseline)]

Критерии участия

Критерии включения

• enrollment of 100 1st, 2nd, and 3rd grade students
• high proportion of children participating in the free and reduced lunch (FRL) program (>70%)
• willingness to implement a coordinated school health (CSH) program

Критерии исключения

• Prior participation in BB in the previous school year
• children or parents identified as special needs per school; or having any physical, cognitive, or psychological disability that would prevent participation in evaluation measures

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

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

Публикации

• Sharma S, Senn M, Chuang RJ, Perkison WB, Crichlow K, Markham C, Ramphul R, Shete S, Basen-Engquist K, McNeill L, Rechis R. Design for a cluster randomized controlled trial to evaluate the impact of a school-based fruit and vegetable co-op on cardiometabolic health of children and parents in a persistent poverty area. Contemp Clin Trials. 2026 Aug;167:108361. doi: 10.1016/j.cct.2026.108361. Epub 2 PMID 42229798

Идентификаторы

NCT: NCT06570707 · HSC-SPH-23-0282 · 5U54CA280804-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗