Food as Medicine Study

NCT07162350 | Not Yet Recruiting

• 1 other identifier: STU20251104
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in Dietary Quality as measured by Diet Quality Index International (DQI-I)

  Dietary quality is measured with the ASA 24-hour dietary recall (ASA 24) and the Diet Quality Index International (DQI-I). The ASA 24 is web-based tool that allows individuals to self-report all foods and beverages consumed in the previous 24 hours ((i.e., the data collection method). The DQI-I is a validated scoring system designed to assess overall diet quality (i.e., measure used to interpret the collected data). Used together, researchers will apply the DQI-I scoring algorithm to the nutrient and food group data collected from ASA 24 to generate a numeric DQI-I score that indicates the overall daily diet quality of the study participant. The DQI-I includes four components (variety 0-20; adequacy 0-40; moderation 0-30; overall balance 0-10) that contribute to a total score out of 100 points with higher scores indicating better diet quality. This allows us to track diet quality changes over time.

  Baseline to 6-months post-intervention

Secondary Outcomes (23)

• Change in Dietary Quality as measured by Diet Quality Index International (DQI-I)

  Baseline to 12-months post-intervention

• Change in Resilience as measured by the Brief Resilience Scale (BRS)

  Baseline to 6-months post-intervention

• Change in Resilience as measured by the Brief Resilience Scale (BRS)

  Baseline to 12-months post-intervention

• Change in perceived stress as measured by the Perceived Stress Scale (PSS)

  Baseline to 6-months post-intervention

• Change in perceived stress as measured by the Perceived Stress Scale (PSS)

  Baseline to 12-months post-intervention

Study Arms (2)

Usual Care

NO INTERVENTION

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.

FAME

EXPERIMENTAL

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.

Behavioral: Food Navigation

Interventions

Food Navigation 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.

FAME

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Parkland Health and Hospital System: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

Parkland Health & Hospital System

Dallas, Texas, 75390, United States

Location

Study Officials

• Jaclyn Albin, MD

  Parkland Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Farra Kahalnik, MPH, MSSW

CONTACT

972-742-8052; Farra.Kahalnik@UTSouthwestern.edu

Meera Patel, PhD

CONTACT

Meera.Patel@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: September 9, 2025
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)