- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06715787
FEAST Perinatal Support Program Intervention
January 29, 2026 updated by: Tyler Mason, University of Southern California
Evaluating the Food Education Access Support Together (FEAST) Perinatal Support Program: A Randomized Controlled Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tyler B Mason, PhD
- Phone Number: (323) 442-8203
- Email: tylermas@usc.edu
Study Locations
-
-
California
-
Los Angeles, California, United States, 90032
- Recruiting
- University of Southern California
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FEAST Perinatal Support Program
Active behavioral intervention
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Current self-efficacy at baseline and immediately post-assessment
|
|
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.
|
Current motivation at baseline and immediately post-assessment
|
|
Mini-EAT 9-item score
Time Frame: Survey at baseline and immediately post-assessment
|
Aggregate score of 9 items on the Mini-EAT survey
|
Survey at baseline and immediately post-assessment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Past 7-day symptoms at baseline and immediately post-assessment
|
|
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.
|
Current at baseline and immediately post-assessment
|
|
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.
|
Current at baseline and immediately post-assessment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Tyler B Mason, PhD, University of Southern California
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2026
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
October 2, 2024
First Submitted That Met QC Criteria
December 3, 2024
First Posted (Actual)
December 4, 2024
Study Record Updates
Last Update Posted (Actual)
February 2, 2026
Last Update Submitted That Met QC Criteria
January 29, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- APP-24-02282
- P50MD017344 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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