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
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