Recruiting

FAME

Sponsor:

Parkland Health and Hospital System

Code:

NCT07162350

Conditions

Chronic Diseases in Children

Eligibility Criteria

Sex: All

Age: 8 - 15

Healthy Volunteers: Not accepted

Interventions

Food Navigation

Study Details

Brief 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

Study ID

NCT07162350

Start date

Jun 1, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 15

Healthy Volunteers: Not accepted

Eligibility Criteria:

Inclusion criteria for the participant include:

1. Between the ages of 8-15 years,
2. Have risk factors of chronic disease based on elevated BMI (>25; 85th percentile),
3. Be seen at one of the selected Parkland COPC clinics,
4. Have not completed a dietitian visit within the last 12 months,
5. Both the participant and caregiver must be fluent in English or Spanish (read, write, and speak) and be willing to participate in the study over a 12-month duration.

Exclusion criteria for the participant include presence of any of the following:

1. Autism with feeding difficulties
2. Intellectual disability
3. Cushing Disease
4. Severe feeding difficulties for over 2 years
5. Dietary restrictions (medically prescribed)
6. Severe food allergy
7. Severe psychiatric disorders
8. Non-alcoholic fatty liver disease
9. Non-alcoholic steatohepatitis
10. Metabolic-associated fatty liver disease
11. Metabolic-associated steatohepatitis
12. Type 1 Diabetes
13. Antipsychotics
14. GLP1 Medication Prescribed
15. Bariatric Surgery
16. Pregnancy

Study Design

Enrollment

250 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Usual Care

The Usual Care control group reflects current clinical practices given to patients. This includes having access to routine wrap around services such as consultation with a dietitian and nutrition education materials. Providers provide references to applicable wrap around services; however, it is ultimately up to the patient to decide to utilize the resources.

experimental: FAME

The FAME intervention will be evaluated with a pragmatic randomized clinical trial. FAME will use a community health worker food navigator embedded in clinical settings to provide education and linkage to a community-based food hub that provides access to community driven food resources.

Interventions

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.

Primary outcome measure

  • Change in Dietary Quality as measured by Diet Quality Index International (DQI-I) [ Time Frame: Baseline to 6-months post-intervention ]

Central Contacts and Locations

Central contacts

Emilie Ruiz

469-285-6848Emilie.Ruiz@UTSouthwestern.edu

Meera Patel, PhD

Meera.Patel@UTSouthwestern.edu

Locations

Parkland Health & Hospital System

Recruiting

Dallas, Texas, United States, 75390

Contacts

Kristin Alvarez

469-419-1816kristin.alvarez@phhs.org

Principal Investigator:

Jaclyn Albin

More Information

Sponsor

Parkland Health and Hospital System

Last update posted

Sep 3, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Parkland Health and Hospital System on 2026-09-03.