FEAST Perinatal Support Program Intervention

NCT06715787 | Recruiting

• 2 other identifiers: APP-24-02282P50MD017344
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diet, Healthy; Obesity; Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (3)

• Mini-EAT 9-item score

  Aggregate score of 9 items on the Mini-EAT survey

  Survey at baseline and immediately post-assessment

• Healthy Eating and Weight Self-Efficacy (HEWSE) score

  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.

  Current self-efficacy at baseline and immediately post-assessment

• Motivation for Dietary Self-Control Scale score

  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.

  Current motivation at baseline and immediately post-assessment

Secondary Outcomes (3)

• 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

Study Arms (1)

FEAST Perinatal Support Program

EXPERIMENTAL

Active behavioral intervention

Behavioral: FEAST Perinatal Support Program

Interventions

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.

FEAST Perinatal Support Program

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Inability to attend in-person sessions

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Children's Hospital Los Angeles: collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90032, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Tyler B Mason, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tyler B Mason, PhD

CONTACT

(323) 442-8203; tylermas@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: One treatment group

Study Record Dates

• First Submitted: October 2, 2024
• First Posted: December 4, 2024
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)