Food as Medicine Study

Official title

Food as Medicine (FAME): An Innovative Approach to Improve Health and Nutrition Security Among High-Risk Children and Families in South Dallas

Overview

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.

Interventions

• Behavioral 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 Motiv

Primary outcome measures

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

Secondary outcome measures (12)

• Change in Dietary Quality as measured by Diet Quality Index International (DQI-I) [Time frame: Baseline to 12-months post-intervention]
• Change in Resilience as measured by the Brief Resilience Scale (BRS) [Time frame: Baseline to 6-months post-intervention]
• Change in Resilience as measured by the Brief Resilience Scale (BRS) [Time frame: Baseline to 12-months post-intervention]
• Change in perceived stress as measured by the Perceived Stress Scale (PSS) [Time frame: Baseline to 6-months post-intervention]
• Change in perceived stress as measured by the Perceived Stress Scale (PSS) [Time frame: Baseline to 12-months post-intervention]
• Change in social support as measured by the Medical Outcomes Study (MOS) Social Support Survey [Time frame: Baseline to 6-months post intervention]
• Change in social support as measured by the Medical Outcomes Study (MOS) Social Support Survey [Time frame: Baseline to 12-months post intervention]
• Change in food security as measured by a standard measure from the USDA Economic Research Services [Time frame: Baseline to 6-months post intervention]
• Change in food security as measured by a standard measure from the USDA Economic Research Services [Time frame: Baseline to 12-months post intervention]
• Change in parental self-efficacy as measured by the Parental Self-Efficacy for Healthy Dietary and Physical Activity Behaviors in Preschoolers Scale (PDAP) [Time frame: Baseline to 6-months post intervention]
• Change in parental self-efficacy as measured by the Parental Self-Efficacy for Healthy Dietary and Physical Activity Behaviors in Preschoolers Scale (PDAP) [Time frame: Baseline to 12-months post intervention]
• Change in child self-efficacy as measured by the Self-Efficacy to Regulate Eating Behaviors Scale for Children (SEREB-C) [Time frame: Baseline to 6-months post intervention]

Eligibility criteria

Eligibility Criteria:

Inclusion criteria for the participant include:

• 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,
• 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:

• Autism with feeding difficulties
• Intellectual disability
• Cushing Disease
• Severe feeding difficulties for over 2 years
• Dietary restrictions (medically prescribed)
• Severe food allergy
• Severe psychiatric disorders
• Non-alcoholic fatty liver disease
• Non-alcoholic steatohepatitis
• Metabolic-associated fatty liver disease
• Metabolic-associated steatohepatitis
• Type 1 Diabetes
• Antipsychotics
• GLP1 Medication Prescribed
• Bariatric Surgery
• Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Parkland Health & Hospital System — Dallas

Identifiers

NCT: NCT07162350 · STU20251104

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗