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Идёт набор NCT06715787

FEAST Perinatal Support Program Intervention

Без фазы С лечением Diet, Healthy Obesity Cardiometabolic Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: FEAST Perinatal Support Program.
Кому может быть актуально
Состояния в реестре: Diet, Healthy, Obesity, Cardiometabolic Syndrome. Базовые параметры: от 18 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

Evaluating the Food Education Access Support Together (FEAST) Perinatal Support Program: A Randomized Controlled Trial

Обзор

Latino individuals face an elevated risk of adverse health outcomes during pregnancy, impacting both the birthing parent and the baby with potential long-term chronic health conditions. While promoting a healthy diet during pregnancy is a promising strategy, interventions targeting dietary behaviors have yielded mixed results and lack widespread dissemination in communities in need. Collaborating with community-based organizations could enhance cultural relevance, build trust with Latino families, and improve program reach and effectiveness. Food Education Access Support Together (FEAST) is a community-based program that promotes healthy eating, well-being, and health equity for diverse, under-resourced urban populations in Los Angeles. The newly developed FEAST Perinatal Support Program (PSP) aims to support individuals through pregnancy and postpartum by providing dietary psychoeducation, skill-building, and social support, with an additional component of grocery gift cards to address food access barriers. This study proposes a pilot trial to assess the feasibility and preliminary efficacy of the FEAST PSP in enhancing dietary outcomes, overall health, and socio-cognitive precursors, in pregnant individuals. The study will enroll 40 pregnant adults in a single-arm study who will receive the core PSP with a $15 gift card for healthful fresh food (PSP+giftcard). Pre- and post-intervention assessments will include questionnaires, dietary recalls, physical measurements, and interviews to evaluate program perceptions. Specific aims include evaluating program feasibility and acceptability (i.e., reach, retention, and participant perceptions) and determining preliminary efficacy on changing socio-cognitive and behavioral aspects of diet, self-reported health, and cardiometabolic risk factors. The project aligns with goals of improving health outcomes in Latino families in Southern California and supports FEAST's strategic objectives for improving health and wellness of individuals during pregnancy and throughout the lifespan. The findings will inform program refinement and future NIH grants for rigorous evaluation of the FEAST PSP.

Вмешательства

  • Поведенческое FEAST Perinatal Support Program
    The intervention will include the core perinatal support program (PSP) with $15 weekly grocery gift cards for healthful food (fruit, vegetables, whole grains), The PSP will be completed during weekly group sessions over 16 weeks. The core PSP includes the two primary behavior change techniques: group-based nutrition education based on current United States Department of Agriculture (USDA) national guidelines for pregnant individuals and guided group sharing and engagement.

Первичные конечные точки

  • Mini-EAT 9-item score [Срок оценки: Survey at baseline and immediately post-assessment]
  • Healthy Eating and Weight Self-Efficacy (HEWSE) score [Срок оценки: Current self-efficacy at baseline and immediately post-assessment]
  • Motivation for Dietary Self-Control Scale score [Срок оценки: Current motivation at baseline and immediately post-assessment]
Вторичные конечные точки (3)
  • Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile v2.0 score [Срок оценки: Past 7-day symptoms at baseline and immediately post-assessment]
  • Body Mass Index value [Срок оценки: Current at baseline and immediately post-assessment]
  • Hemoglobin A1C (HbA1c) recording [Срок оценки: Current at baseline and immediately post-assessment]

Критерии участия

Критерии включения

  • Currently pregnant
  • Speak and read English
  • Eligible for Electronics Benefit Transfer (EBT) and/or Women, Infants, and Children (WIC) benefits

Критерии исключения

  • Inability to attend in-person sessions

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • University of Southern California — Los Angeles

Идентификаторы

NCT: NCT06715787 · APP-24-02282 · P50MD017344

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗