FEAST Perinatal Support Program Intervention

NCT ID: NCT06715787

Last Updated: 2024-12-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2025-09-30

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.

Conditions

Diet, Healthy; Obesity; Cardiometabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

FEAST Perinatal Support Program

Active behavioral intervention

Group Type: EXPERIMENTAL

FEAST Perinatal Support Program

Intervention Type: 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.

Control with standard care

This arm is a waitlist control with receipt of written materials on improving diet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

FEAST Perinatal Support Program

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Tyler Mason

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tyler B Mason, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Central Contacts

Tyler B Mason, PhD

Role: CONTACT

Phone: (323) 442-8203

Email: tylermas@usc.edu

Other Identifiers

P50MD017344

Identifier Type: NIH

Identifier Source: secondary_id

View Link

APP-24-02282

Identifier Type: -

Identifier Source: org_study_id