Food as Medicine Study

NCT ID: NCT07162350

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2028-06-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Food Navigation

Intervention Type: BEHAVIORAL

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.

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• between the ages of 8-15 years,
• BMI > 85th percentile, and
• be seen at one of the selected Parkland COPC (Community Oriented Primary Care) clinics.
• 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

• has seen a dietitian within the last year,
• presence of an intellectual disability,
• diagnosed with autism with severe feeding difficulties,
• past medical history of severe feeding difficulties over the age of 2 years,
• has had bariatric surgery
• is taking a GLP-1
• diagnosed with type 1 diabetes
• is taking anti-psychotics
• has severe food allergies
• has a severe psychiatric disorder
• has a disease that would not allow the individual to change their diet, and
• any other reason the PIs deem someone ineligible.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: collaborator

Parkland Health and Hospital System

OTHER

Sponsor Role: lead

Responsible Party

Jaclyn Albin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jaclyn Albin, MD

Role: PRINCIPAL_INVESTIGATOR

Parkland Health

Locations

Parkland Health & Hospital System

Dallas, Texas, United States

Countries

United States

Central Contacts

Farra Kahalnik, MPH, MSSW

Role: CONTACT

Farra.Kahalnik@UTSouthwestern.edu

972-742-8052

Meera Patel, PhD

Role: CONTACT

Meera.Patel@UTSouthwestern.edu

Facility Contacts

Kristin Alvarez

Role: primary

kristin.alvarez@phhs.org

469-419-1816

Other Identifiers

STU20251104

Identifier Type: -

Identifier Source: org_study_id