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NCT Number: NCT06715787

FEAST Perinatal Support Program Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California

Los Angeles, California, 90032, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Inability to attend in-person sessions

Treatment and study plan

FEAST Perinatal Support Program

Behavioral

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.

Primary outcomes

  1. Mini-EAT 9-item score

    Time frame: Survey at baseline and immediately post-assessment

    Aggregate score of 9 items on the Mini-EAT survey

  2. Healthy Eating and Weight Self-Efficacy (HEWSE) score

    Time frame: 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.

  3. Motivation for Dietary Self-Control Scale score

    Time frame: 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.

Secondary outcomes

  1. Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile v2.0 score

    Time frame: Past 7-day symptoms at baseline and immediately post-assessment

    The PROMIS is a self-report questionnaire measuring overall physical and mental health. PROMIS scores range from 0-5 with higher scores indicating worse mental and physical health.

  2. Body Mass Index value

    Time frame: Current at baseline and immediately post-assessment

    Body mass index is calculated using measured height and weight. Higher scores indicate greater obesity risk.

  3. Hemoglobin A1C (HbA1c) recording

    Time frame: Current at baseline and immediately post-assessment

    HbA1c is calculated using finger prick blood test. Values typically range from 5 to 12 with lower scores indicating less diabetes risk.

Study contacts

Contact information is provided by the study sponsor or research team.

Tyler B Mason, PhD

CONTACT

[email protected]

(323) 442-8203

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Children's Hospital Los Angeles
  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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