Food as Medicine Study

Part of paid clinical trials in Dallas, Texas.

Sponsor
Parkland Health and Hospital System
Study ID
NCT07162350
Status
Not Yet Recruiting

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Conditions

  • Chronic Diseases in Children

Eligibility Criteria

Sex
ALL
Age
8 Years - 15 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Parkland Health & Hospital SystemDallasTexas75390
Kristin Alvarez
[email protected]
469-419-1816
Jaclyn Albin (PRINCIPAL_INVESTIGATOR)

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By research site
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