Chronic Diseases in ChildrenFAMENCT07162350
Food as Medicine Study
A study testing Food Navigation in people with Chronic Diseases in Children, run by Parkland Health and Hospital System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Chronic Diseases in Children
- What is being tested?
- Food Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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:
Show all 22Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Meera Patel, PhD contact
United States1 site, 1 recruiting
- Recruiting
Parkland Health & Hospital System
Dallas, Texas, 75390
Kristin Alvarez, 469-419-1816, kristin.alvarez@phhs.org
Jaclyn Albin
About this 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
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.
Read more
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.
- Conditions
- Chronic Diseases in Children
- Being tested
- Food Navigation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food NavigationBehavioural
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:
- 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.
- 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.
- Provide nutrition resources and referrals.
- Support children and families for up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | 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 | Experimental | 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. Receives: Behavioral: Food Navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 6-months post-intervention
Secondary outcomes (23)
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.
Measured: Baseline to 12-months post-intervention
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.
Measured: Baseline to 6-months post-intervention
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.
Measured: Baseline to 12-months post-intervention
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.
Measured: Baseline to 6-months post-intervention
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.
Measured: Baseline to 12-months post-intervention
Change in social support as measured by the Medical Outcomes Study (MOS) Social Support Survey
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.
Measured: Baseline to 6-months post intervention
Change in social support as measured by the Medical Outcomes Study (MOS) Social Support Survey
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.
Measured: Baseline to 12-months post intervention
Change in food security as measured by a standard measure from the USDA Economic Research Services
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
Measured: Baseline to 6-months post intervention
Change in food security as measured by a standard measure from the USDA Economic Research Services
The six-item standard measure from the U.S. Department of Agriculture 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
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline to 12-months post intervention
Change in dietary behavior as measured by the Mini-EAT survey
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<)
Measured: Baseline to 6-months post-intervention
Change in dietary behavior as measured by the Mini-EAT survey
The Mini-EAT 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<)
Measured: Baseline to 12-months post-intervention
Change in BMI of child participants at 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).
Measured: Baseline to 6-months post-intervention
Change in BMI of child participants at 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).
Measured: Baseline to 12-months post-intervention
Change in Blood pressure of child participants at 6 months post-intervention
Child health outcomes will be evaluated with electronic health records, including systolic and diastolic blood pressure data.
Measured: Baseline to 6-months post-intervention
Change in Blood pressure of child participants at 12 months post-intervention
Child health outcomes will be evaluated with electronic health records, including systolic and diastolic blood pressure data.
Measured: Baseline to 12-months post-intervention
Change in Glycated hemoglobin (HbA1c) of child participants at 6 months post-intervention
Child health outcomes will be evaluated with electronic health records, including glycated hemoglobin (HbA1c) data.
Measured: Baseline to 6-months post-intervention
Change in Glycated hemoglobin (HbA1c) of child participants at 12 months post-intervention
Child health outcomes will be evaluated with electronic health records, including glycated hemoglobin (HbA1c) data.
Measured: Baseline to 12-months post-intervention
Change in Alanine transaminase (ALT) of child participants at 6 months post-intervention
Child health outcomes will be evaluated with electronic health records, including alanine transaminase (ALT) data.
Measured: Baseline to 6-months post-intervention
Change in Alanine transaminase (ALT) of child participants at 12 months post-intervention
Child health outcomes will be evaluated with electronic health records, including alanine transaminase (ALT) data.
Measured: Baseline to 12-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start1 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Diseases in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parkland Health and Hospital System
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Responsible party
- Principal investigator, Jaclyn Albin, University of Texas Southwestern Medical Center
- Investigators
- Jaclyn Albin, MD, Principal investigator, Parkland Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162350
- Sponsor's protocol ID
- STU20251104
- Acronym
- FAME
- Status last verified
- Aug 2026
- First submitted
- 1 Jul 2025
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share individual participant data (IPD) with other researchers. If this decision changes, an IPD sharing plan will be provided according to institutional regulations at a later time.
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food as Medicine (FAME): An Innovative Approach to Improve Health and Nutrition Security Among High-Risk Children and Families in South Dallas
- ClinicalTrials.gov ID
- NCT07162350
- Acronym / sponsor ID
- FAME / STU20251104
- Conditions
- Chronic Diseases in Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Parkland Health and Hospital SystemUniversity, hospital or other
- Collaborators
- University of Texas Southwestern Medical Center
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –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 | Experimental | Behavioral: Food NavigationThe 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. |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food NavigationFor 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. | Behavioural | FAME |
Primary outcome
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.
23 secondary outcomes
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
Change in child self-efficacy as measured by the Self-Efficacy to Regulate Eating Behaviors Scale for Children (SEREB-C)
Time frame: Baseline to 12-months post intervention
Change in dietary behavior as measured by the Mini-EAT survey
Time frame: Baseline to 6-months post-intervention
Change in dietary behavior as measured by the Mini-EAT survey
Time frame: Baseline to 12-months post-intervention
Change in BMI of child participants at 6 months post-intervention
Time frame: Baseline to 6-months post-intervention
Change in BMI of child participants at 12 months post-intervention
Time frame: Baseline to 12-months post-intervention
Change in Blood pressure of child participants at 6 months post-intervention
Time frame: Baseline to 6-months post-intervention
Change in Blood pressure of child participants at 12 months post-intervention
Time frame: Baseline to 12-months post-intervention
Change in Glycated hemoglobin (HbA1c) of child participants at 6 months post-intervention
Time frame: Baseline to 6-months post-intervention
Change in Glycated hemoglobin (HbA1c) of child participants at 12 months post-intervention
Time frame: Baseline to 12-months post-intervention
Change in Alanine transaminase (ALT) of child participants at 6 months post-intervention
Time frame: Baseline to 6-months post-intervention
Change in Alanine transaminase (ALT) of child participants at 12 months post-intervention
Time frame: Baseline to 12-months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No. There is no current plan to share individual participant data (IPD) with other researchers. If this decision changes, an IPD sharing plan will be provided according to institutional regulations at a later time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meera Patel, PhD contact
Jaclyn Albin, MD principal investigator
Parkland Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Navigation in people with Chronic Diseases in Children, run by Parkland Health and Hospital System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie Ruiz (469-285-6848, Emilie.Ruiz@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dietary Quality as measured by Diet Quality Index International (DQI-I) (time frame: Baseline to 6-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.