Food as Medicine Study
ConditionChronic Diseases in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-15
SponsorParkland Health and Hospital System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
Autism with feeding difficulties
Intellectual disability
Cushing Disease
Severe feeding difficulties for over 2 years
Trial design
Design model
Parallel
Treatments tested in this trial
Food Navigation
BehavioralFor 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.
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Usual CareNo intervention 0 interventions
Group B: FAMEExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline to 6-months post-interventionSecondary 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.
Time frame
Baseline to 12-months post-intervention2
Change in Resilience as measured by the Brief Resilience Scale (BRS)
The 6-item BRS uses a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). Items 1, 3, and 5 are positively worded, and items 2, 4, and 6 are negatively worded. The BRS is scored by reverse coding items 2, 4, and 6 and finding the mean of the 6 items. A higher score indicates a higher level of resilience.
Time frame
Baseline to 6-months post-intervention3
Change in Resilience as measured by the Brief Resilience Scale (BRS)
The 6-item BRS uses a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). Items 1, 3, and 5 are positively worded, and items 2, 4, and 6 are negatively worded. The BRS is scored by reverse coding items 2, 4, and 6 and finding the mean of the 6 items. A higher score indicates a higher level of resilience.
Time frame
Baseline to 12-months post-intervention4
Change in perceived stress as measured by the Perceived Stress Scale (PSS)
The 10-item PSS uses a 5-point Likert scale (0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often). PSS scores are obtained by reversing responses to the four positively stated items (items 4, 5, 7, \& 8) and then summing across all scale items. Higher scores indicate higher levels of perceived stress.
Time frame
Baseline to 6-months post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Parkland Health and Hospital System
Lead sponsor
University of Texas Southwestern Medical Center
Sponsor institution
University of Texas Southwestern Medical Center
Collaborator
Source ClinicalTrials.gov
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