Food as Medicine (FAME): An Innovative Approach to Improve Health and Nutrition Security Among High-Risk Children and Families in South Dallas
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Parkland Health and Hospital System
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Change in Dietary Quality as measured by Diet Quality Index International (DQI-I)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
Arms & Interventions
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.
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.
Intervention: Food Navigation (Behavioral)
Outcomes
Primary Outcomes
Change in Dietary Quality as measured by Diet Quality Index International (DQI-I)
Time Frame: Baseline to 6-months post-intervention
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.
Secondary Outcomes
- 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 12-months post-intervention)
- Change in perceived stress as measured by the Perceived Stress Scale (PSS)(Baseline to 12-months post-intervention)
- Change in social support as measured by the Medical Outcomes Study (MOS) Social Support Survey(Baseline to 12-months post intervention)
- Change in food security as measured by a standard measure from the USDA Economic Research Services(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)(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)(Baseline to 12-months post intervention)
- Change in dietary behavior as measured by the Mini-EAT survey(Baseline to 12-months post-intervention)
- Change in BMI of child participants at 6 months post-intervention(Baseline to 6-months post-intervention)
- Change in BMI of child participants at 12 months post-intervention(Baseline to 12-months post-intervention)
- Change in Blood pressure of child participants at 12 months post-intervention(Baseline to 12-months post-intervention)
- Change in Glycated hemoglobin (HbA1c) of child participants at 6 months post-intervention(Baseline to 6-months post-intervention)
- Change in Blood pressure of child participants at 6 months post-intervention(Baseline to 6-months post-intervention)
- Change in Glycated hemoglobin (HbA1c) of child participants at 12 months post-intervention(Baseline to 12-months post-intervention)
- Change in Alanine transaminase (ALT) of child participants at 6 months post-intervention(Baseline to 6-months post-intervention)
- Change in Alanine transaminase (ALT) of child participants at 12 months post-intervention(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 perceived stress as measured by the Perceived Stress Scale (PSS)(Baseline to 6-months post-intervention)
- Change in social support as measured by the Medical Outcomes Study (MOS) Social Support Survey(Baseline to 6-months post intervention)
- Change in food security as measured by a standard measure from the USDA Economic Research Services(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)(Baseline to 6-months post intervention)
- Change in child self-efficacy as measured by the Self-Efficacy to Regulate Eating Behaviors Scale for Children (SEREB-C)(Baseline to 6-months post intervention)
- Change in dietary behavior as measured by the Mini-EAT survey(Baseline to 6-months post-intervention)
Investigators
Jaclyn Albin
Associate Professor
University of Texas Southwestern Medical Center