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Food as Medicine Study

NCT07162350 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-04-06

No results posted yet for this study

Summary

The Food as Medicine (FAME) intervention aims to improve dietary quality in lower income, primarily ethnic minority youth through food navigation that bridges clinical care and community food resources. This study will evaluate the FAME intervention on dietary quality, food behaviors, health outcomes, and cost-effectiveness, using a pragmatic randomized clinical trial design in 250 at risk youth (8-15 years of age) and their caregiver(s) as compared to Usual Care through the following aims:

Aim 1: To evaluate the impact of the FAME intervention on child and caregiver(s) dietary quality at 6 and 12 months as compared to Usual Care. Hypothesis: FAME participants will have increased dietary quality as measured by ASA-24/DQI.

Aim 2: To assess the intervention's impact on food behaviors, food insecurity, healthy food sourcing, knowledge, self-efficacy, health outcomes and cost-effectiveness at 6 and 12 months as compared to Usual Care.

Aim 3: Evaluate implementation outcomes including dose, satisfaction, and individual interviews and focus groups with youth, parents, physicians, clinic staff, community partners, and CHWs.

Conditions

  • Chronic Diseases in Children

Interventions

BEHAVIORAL

Food Navigation

For those randomized to the FAME Intervention, it will begin with a Community Health Worker (CHW) Food Navigator consultation. The role of the Food Navigators is as follows: 1. Identify the top dietary and food needs of the participant and their family. The Food Navigator will perform a needs assessment to define food access, kitchen resources/capacity, and other social determinants of health. 2. Set realistic, participant and family-driven nutrition goals. The Food Navigator will utilize Motivational Interviewing (MI), an evidence-based method of counseling that promotes motivation for change. 3. Provide nutrition resources and referrals. 4. Support children and families for up to 12 months.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • Parkland Health and Hospital System

    lead OTHER

Principal Investigators

  • Jaclyn Albin, MD · Parkland Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-31
Completion
2028-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07162350 on ClinicalTrials.gov