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临床试验/NCT06715787
NCT06715787招募中不适用

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

University of Southern California1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Mini-EAT 9-item score

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

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

排除标准

  • •Inability to attend in-person sessions

研究组 & 干预措施

FEAST Perinatal Support Program

Experimental

Active behavioral intervention

干预措施: FEAST Perinatal Support Program (Behavioral)

结局指标

主要结局

Mini-EAT 9-item score

时间窗: Survey at baseline and immediately post-assessment

Aggregate score of 9 items on the Mini-EAT survey

Healthy Eating and Weight Self-Efficacy (HEWSE) score

时间窗: Current self-efficacy at baseline and immediately post-assessment

The HEWSE is a self-report questionnaire that assesses healthy eating and healthy weight self-efficacy. The scores range from 1-5 with higher scores indicating better self-efficacy.

Motivation for Dietary Self-Control Scale score

时间窗: Current motivation at baseline and immediately post-assessment

The Motivation for Dietary Self-Control Scale is a self-report questionnaire that assesses motivations for dietary change with three sub scales: Dietary Goal-Desire Incongruence, Motivation for Dietary Self-control, and Satisfaction with Dietary Behavior. The scores for each subscale range from 0-6 with higher scores indicating better motivation.

次要结局

  • Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile v2.0 score(Past 7-day symptoms at baseline and immediately post-assessment)
  • Body Mass Index value(Current at baseline and immediately post-assessment)
  • Hemoglobin A1C (HbA1c) recording(Current at baseline and immediately post-assessment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tyler Mason

Associate Professor

University of Southern California

研究点 (1)

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