Chronic Diseases in Children
Conditions
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.
Interventions
BEHAVIORALFood 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 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.
Sponsors
Parkland Health and Hospital System
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
Eligibility Criteria: Inclusion criteria for the participant include: 1. Between the ages of 8-15 years, 2. Have risk factors of chronic disease based on elevated BMI (\>25; 85th percentile), 3. Be seen at one of the selected Parkland COPC clinics, 4. Have not completed a dietitian visit within the last 12 months, 5. 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: 1. Autism with feeding difficulties 2. Intellectual disability 3. Cushing Disease 4. Severe feeding difficulties for over 2 years 5. Dietary restrictions (medically prescribed) 6. Severe food allergy 7. Severe psychiatric disorders 8. Non-alcoholic fatty liver disease 9. Non-alcoholic steatohepatitis 10. Metabolic-associated fatty liver disease 11. Metabolic-associated steatohepatitis 12. Type 1 Diabetes 13. Antipsychotics 14. GLP1 Medication Prescribed 15. Bariatric Surgery 16. Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dietary Quality as measured by Diet Quality Index International (DQI-I) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Glycated hemoglobin (HbA1c) of child participants at 12 months post-intervention | Baseline to 12-months post-intervention | Child health outcomes will be evaluated with electronic health records, including glycated hemoglobin (HbA1c) data. |
| Change in Alanine transaminase (ALT) of child participants at 6 months post-intervention | Baseline to 6-months post-intervention | Child health outcomes will be evaluated with electronic health records, including alanine transaminase (ALT) data. |
| Change in Alanine transaminase (ALT) of child participants at 12 months post-intervention | Baseline to 12-months post-intervention | Child health outcomes will be evaluated with electronic health records, including alanine transaminase (ALT) data. |
| Change in Dietary Quality as measured by Diet Quality Index International (DQI-I) | Baseline to 12-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. |
| Change in Resilience as measured by the Brief Resilience Scale (BRS) | Baseline to 6-months post-intervention | 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. |
| Change in perceived stress as measured by the Perceived Stress Scale (PSS) | Baseline to 6-months post-intervention | 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. |
| Change in social support as measured by the Medical Outcomes Study (MOS) Social Support Survey | Baseline to 6-months post intervention | The Medical Outcomes Study (MOS) Social Support Survey is a self-administered questionnaire that that includes 19 items across four functional support subscales: emotional/informational support (8 items), tangible/instrumental support (4 items), affectionate support (3 items), and positive social interaction (3 items). Each item is scored on a 5-point Likert style scale (1 = None of the Time; 5 = All of the Time) to indicate how often that type of support is available to them. A score for each social support subscale can be computed by averaging across the individual items or by adding scores individual items together. Higher scores indicate more support. |
| Change in food security as measured by a standard measure from the USDA Economic Research Services | Baseline to 6-months post intervention | The six-item standard measure from the U.S. Department of Agriculture (USDA) Economic Research Service is modeled using information from the Community Population Survey, Bureau of Labor Statistics, and American Community Survey. Food security status is assigned as follows: Raw score 0-1 - High or marginal food security (raw score 1 may be considered marginal food security, but a large proportion of households that would be measured as having marginal food security using the household or adult scale will have raw score zero on the six-item scale) Raw score 2-4 - Low food security Raw score 5-6 - Very low food security |
| 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 | Parental self-efficacy (PSE) refers to beliefs of parents to effectively engage in behaviors that result in desired outcomes for their children. The PDAP instrument measures PSE in relation to contextual circumstances, for example, psychological states and situational demands. Responses are made according to an 11-point Likert scale, with anchors at 0 (not at all confident), 5 (moderately confident), and 10 (completely confident). A higher score indicates a higher level of PSE. |
| 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 | The SEREB-C is a 14-item self-report tool designed to measure children's perceived self-efficacy to choose healthy eating behaviors in challenging contexts. The points of the individual items are summed to create a composite score ranging from 8 to 40 for the activation and temptation situations subscale and from 6 to 30 for the negative emotional situations subscale (combined, total score ranges from 14 to 70). Higher scores imply greater self-efficacy in regulating eating behaviors in challenging situations. |
| Change in dietary behavior as measured by the Mini-EAT survey | Baseline to 6-months post-intervention | The Mini-EAT (Eating Assessment Tool) is a dietary assessment tool designed to evaluate the quality of a person's diet. It ranges from a low of 36 to a high of 90. Scores are categorized into three levels: unhealthy (\<61), intermediate (61-69), and healthy (69\<) |
| Change in BMI of child participants at 6 months post-intervention | Baseline to 6-months post-intervention | Child health outcomes will be evaluated with electronic health records, including body mass index (BMI) (weight and height will be combined to report BMI in kg/m\^2). |
| Change in BMI of child participants at 12 months post-intervention | Baseline to 12-months post-intervention | Child health outcomes will be evaluated with electronic health records, including body mass index (BMI) (weight and height will be combined to report BMI in kg/m\^2). |
| Change in Blood pressure of child participants at 6 months post-intervention | Baseline to 6-months post-intervention | Child health outcomes will be evaluated with electronic health records, including systolic and diastolic blood pressure data. |
| Change in Glycated hemoglobin (HbA1c) of child participants at 6 months post-intervention | Baseline to 6-months post-intervention | Child health outcomes will be evaluated with electronic health records, including glycated hemoglobin (HbA1c) data. |
| Change in Blood pressure of child participants at 12 months post-intervention | Baseline to 12-months post-intervention | Child health outcomes will be evaluated with electronic health records, including systolic and diastolic blood pressure data. |
Countries
United States
Contacts
CONTACTEmilie Ruiz
CONTACTMeera Patel, PhD
PRINCIPAL_INVESTIGATORJaclyn Albin, MD
Parkland Health
Outcome results
None listed