Food as Medicine Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-15
SponsorParkland Health and Hospital System

About this trial

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.

Eligibility criteria

Qualifiers

Between the ages of 8-15 years,

Have risk factors of chronic disease based on elevated BMI (>25; 85th percentile),

Be seen at one of the selected Parkland COPC clinics,

Have not completed a dietitian visit within the last 12 months,

Disqualifiers

Autism with feeding difficulties

Intellectual disability

Cushing Disease

Severe feeding difficulties for over 2 years

Trial design

Treatments tested in this trial

  • Food Navigation

Treatment groups

250 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Parkland Health and Hospital System

Lead sponsor

University of Texas Southwestern Medical Center

Sponsor institution

University of Texas Southwestern Medical Center

Collaborator