Clinical trial NCT06715787: FEAST Perinatal Support Program Intervention
Official title: Evaluating the Food Education Access Support Together (FEAST) Perinatal Support Program: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diet, Healthy
Obesity
Cardiometabolic Syndrome
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Children's Hospital Los Angeles
First posted: 2024-12-04
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One treatment group and one control group
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Healthy Eating Index (HEI) score
timeFrame: 24 hour recall at baseline and immediately post-assessment
measure: Healthy Eating and Weight Self-Efficacy (HEWSE) score
timeFrame: Current self-efficacy at baseline and immediately post-assessment
measure: Consumer Nutrition Knowledge Scale (CoNKS) score
timeFrame: Current knowledge at baseline and immediately post-assessment
measure: Motivation for Dietary Self-Control Scale score
timeFrame: Current motivation at baseline and immediately post-assessment
Secondary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) 29 Profile v2.0 score
timeFrame: Past 7-day symptoms at baseline and immediately post-assessment
measure: Social Connectedness Scale-Revised score
timeFrame: Current social connection at baseline and immediately post-assessment
measure: Body Mass Index value
timeFrame: Current at baseline and immediately post-assessment
measure: Hemoglobin A1C (HbA1c) recording
timeFrame: Current at baseline and immediately post-assessment
Other outcomes:
Locations:
Study officials:
affiliation: University of Southern California
name: Tyler B Mason, PhD
role: PRINCIPAL_INVESTIGATOR
References: