FEAST Perinatal Support Program Intervention

Not Applicable

Not yet recruiting

• Conditions: Diet, Healthy; Obesity; Cardiometabolic Syndrome

• Registration Number: NCT06715787
• Lead Sponsor: University of Southern California

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 randomized controlled 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 (\>70% Latino) randomly assigned to one of two different groups: core PSP with a $15 gift card for healthful fresh food (PSP+giftcard) and a waitlist control group. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-02
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-03
• Last Update Submitted: 2024-12-03
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-06
• Study Start: 2025-01
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

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

Exclusion Criteria

• Inability to attend in-person sessions

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Healthy Eating Index (HEI) score	24 hour recall at baseline and immediately post-assessment	The HEI score is calculated using two 24 hour recalls. The score can range from 0-100 with higher scores indicating better dietary quality.
Healthy Eating and Weight Self-Efficacy (HEWSE) score	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.
Consumer Nutrition Knowledge Scale (CoNKS) score	Current knowledge at baseline and immediately post-assessment	The CoNKS is a self-report questionnaire that assesses general nutrition knowledge. The scores range from 0-20 with higher scores indicating better nutrition knowledge.
Motivation for Dietary Self-Control Scale score	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 Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile v2.0 score	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.
Social Connectedness Scale-Revised score	Current social connection at baseline and immediately post-assessment	The Social Connectedness Scale-Revised is a self-report questionnaire that assesses overall social connection. The scores range from 1-6 with higher scores indicating more social connection.
Body Mass Index value	Current at baseline and immediately post-assessment	Body mass index is calculated using measured height and weight. Higher scores indicate greater obesity risk.
Hemoglobin A1C (HbA1c) recording	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.