Type I DiabetesNCT07535502
Food is Medicine in Pediatric Patients With Diabetes
A study testing Community Servings, PedsQL Survey and Nutrition Counseling in people with Type I Diabetes and Pediatrics, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The objective of this randomized controlled trial is to evaluate the effect of novel Food is Medicine Programming in the form of medically tailored pre-packaged meals for pediatric patients with Type 1 Diabetes. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Type I Diabetes, Pediatrics, Food Insecurity
- What is being tested?
- Community Servings, PedsQL Survey and Nutrition Counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to 31 Dec 2029
- 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 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Current patients of the UMMMC Pediatric Endocrinology Clinic
- Children and Adolescents less than or equal to 17 years of age at the time of enrollment
- Diagnosed with Type 1 Diabetes at least 3 months ago
- Public (MassHealth or Medicaid) Health Insurance
Who cannot join
- Celiac disease or severe gluten allergy
- Congenital, genetic, or chronic comorbidities
- DCF Custody
- Pregnant women
- Prisoners
- Non-English speaking subjects
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UMass Memorial Children's Medical Center
Worcester, Massachusetts, 01655
Madeline E French, BS, MBE, 5088870106, madeline.french2@umassmed.edu
Lawrence Rhein, MD, MPH
About this study
Official title: The Effect of a Novel Food is Medicine Program on Outcomes in Pediatric Patients With Diabetes: A Randomized Controlled Trial
The objective of this randomized controlled trial is to evaluate the effect of novel Food is Medicine Programming in the form of medically tailored pre-packaged meals for pediatric patients with Type 1 Diabetes. The provision of medically-tailored meals to children and adolescents with diabetes that have potential food security or access concerns in addition to nutrition counseling will improve clinical outcomes, decrease healthcare utilization, and improve health-related quality of life (HRQOL). Consulting with a Registered Dietician is the established multidisciplinary standard of care for pediatric patients with diabetes at UMass. Community Servings provides a medically-tailored pre-packaged meal plan designed for pediatric patients with Type 1 Diabetes. The addition of Community Servings to the current standard of care in pediatric patients with potential food security or access concerns will further improve clinical, decrease healthcare utilization, and improve HRQOL outcomes in pediatric patients with Type 1 Diabetes.
- Conditions
- Type I Diabetes, Pediatrics, Food Insecurity
- Being tested
- Community Servings, PedsQL Survey, Nutrition Counseling, SDOH Survey
- Keywords
- Food is Medicine, Type I Diabetes, Pediatrics, Food Insecurity, Continuous Glucose Monitoring, Medically-tailored Meals
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community ServingsOther
Participants randomized to the intervention group will receive the Community Servings medically-tailored meal plan for the first 6 months after enrollment. The Community Servings plan will provide 10 medically-tailored meals per week, delivered to the participant residence on the day of the week preferred by the participant. Following enrollment, participants will meet with a Community Servings team member to review dietary restrictions. The meals were designed by Registered Dieticians for children and adolescents with Type 1 Diabetes and will be prepared and distributed by the Community Servings team. Participants in the intervention arm will also be asked to complete a survey on the utility of the Community Servings intervention at the conclusion of the program, 6 months after initial enrollment. The survey and responses will be housed in the REDCap.
PedsQL SurveyOther
All participants or their parents will complete a baseline quality of life assessment appropriate for their age group and again at 3 months, 6 months, and at end of follow-up at 12 months. The PedsQL Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. This model integrates multidimensional physical, emotional, social, and school functioning scales and reports total, physical health, and psychological health summary scores. This survey can be completed in person with research staff, over the phone with research staff, or remotely via a link distributed from the REDCap database. Responses will be stored in the REDCap database.
Nutrition CounselingOther
Participants will recieve standare-of-care nutrition counseling from a registered dietician with the UMass Pediatric Endocrinology clinic to receive education and review dietary and nutrition recommendations personalized to the patient and management of Type I diabetes.
SDOH SurveyOther
All participants or their parents will complete a baseline social driver of health (SDOH) survey at the time of enrollment and again at 3 months, 6 months, and at end of follow-up at 12 months. The SDOH survey is provided for all patients at UMass and evaluates the risk for food, housing, utility, and transportation concerns. This survey can be completed in person with research staff, over the phone with research staff, or remotely via a link distributed from the REDCap database. Responses will be stored in the REDCap database.
| Study group | Role | What they receive |
|---|---|---|
| Community Servings | Experimental | The treatment group will receive six months of medically-tailored meals for pediatric Type I Diabetes through Community Servings non-profit organization in addition to standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Participants will have a six-month follow-up period following completion of the medically tailored meals programming. Subjects will complete the PedsQL quality of life surveys, program-specific surveys on medically-tailored meals with Community Servings, and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study. Receives: Other: Community Servings; Other: PedsQL Survey; Other: Nutrition Counseling; Other: SDOH Survey |
| Standard of Care Pediatric Type I Diabetes | Active comparator | The control group will receive twelve months of standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Subjects will complete the PedsQL quality of life surveys and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study. If the subject completes all study procedures, they will have the option to access six months of Community Servings medically-tailored meals provided by the research institution upon completion of the study. Receives: Other: PedsQL Survey; Other: Nutrition Counseling; Other: SDOH Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in nutrition-related clinical outcomes
The primary outcome measure is the difference in clinical outcomes between the control and intervention groups. Nutrition-related outcomes will include growth metrics (Z-score and percentile rank), and height and weight will be combined to report Body Mass Index (BMI) in kg/m^2 metrics.
Measured: 12 months
Difference in Diabetes-related clinical outcomes
One primary outcome measure is the difference in clinical outcomes between the control and intervention groups. Diabetes outcomes will include changes in insulin dosage (units/mL/day), continuous glucose monitoring metrics (glucose in mg/dL, time spent at range intervals and variability as percentages), and Hemoglobin A1c (percentage).
Measured: 12 months
Secondary outcomes (3)
Healthcare Utilization
A secondary outcome measure is the difference in healthcare utilization outcomes between the control and intervention groups. Healthcare utilization will be determined by additional insulin refill requests, urgent care visits, emergency room visits, and hospital admissions during the study and follow-up period.
Measured: 12 months
HRQOL Outcomes
A secondary outcome measure is the difference in HRQOL outcomes between the control and intervention groups. HRQOL will be determined by the PedsQL survey for the appropriate age group at timepoints 0, 3, 6, and 12 months.
Measured: 12 months
Medically-tailored Meals Sustainability
A secondary outcome measure within the intervention arm only will be a qualitative analysis of the survey responses regarding utility of the Community Servings intervention at conclusion of the intervention to sustainability practices at end of study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start5 Oct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Type I DiabetesStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Rhein, University of Massachusetts, Worcester
- Investigators
- Lawrence Rhein, MD, MPH, Principal investigator, UMass Chan Medical SchoolArvin Garg, MD, MPH, Principal investigator, UMass Chan Medical SchoolLeslie Soyka, MD, Principal investigator, UMass Chan Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07535502
- Sponsor's protocol ID
- STUDY00002969
- Status last verified
- Sep 2026
- First submitted
- 30 Mar 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Erika Hanson, Sara Raza, Katie Garfield, Erin Mizraki, Hannah Rahim, Jessica Samuels, Carmel Shachar, Emily Broad Leib, Alissa Wassung, and Cate Hensley; Food is Medicine: A State Medicaid Policy Toolkit; Harvard Law School Center for Health Law and Policy Innovation and Food is Medicine Coalition
Drewnowski A, Specter SE. Poverty and obesity: the role of energy density and energy costs. Am J Clin Nutr. 2004 Jan;79(1):6-16. doi: 10.1093/ajcn/79.1.6.
PubMed 14684391Gundersen C, Ziliak JP. Food Insecurity And Health Outcomes. Health Aff (Millwood). 2015 Nov;34(11):1830-9. doi: 10.1377/hlthaff.2015.0645.
PubMed 26526240Chobot A, Piona C, Bombaci B, Kaminska-Jackowiak O, Mancioppi V, Passanisi S. Exploring the Continuous Glucose Monitoring in Pediatric Diabetes: Current Practices, Innovative Metrics, and Future Implications. Children (Basel). 2024 Jul 27;11(8):907. doi: 10.3390/children11080907.
PubMed 39201842
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Novel Food is Medicine Program on Outcomes in Pediatric Patients With Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07535502
- Acronym / sponsor ID
- STUDY00002969
- Conditions
- Type I Diabetes, Pediatrics, Food Insecurity
- Keywords
- Food is Medicine, Type I Diabetes, Pediatrics, Food Insecurity, Continuous Glucose Monitoring, Medically-tailored Meals
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 17 Apr 2026 (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 objective of this randomized controlled trial is to evaluate the effect of novel Food is Medicine Programming in the form of medically tailored pre-packaged meals for pediatric patients with Type 1 Diabetes. The provision of medically-tailored meals to children and adolescents with diabetes that have potential food security or access concerns in addition to nutrition counseling will improve clinical outcomes, decrease healthcare utilization, and improve health-related quality of life (HRQOL). Consulting with a Registered Dietician is the established multidisciplinary standard of care for pediatric patients with diabetes at UMass. Community Servings provides a medically-tailored pre-packaged meal plan designed for pediatric patients with Type 1 Diabetes. The addition of Community Servings to the current standard of care in pediatric patients with potential food security or access concerns will further improve clinical, decrease healthcare utilization, and improve HRQOL outcomes in pediatric patients with Type 1 Diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Community Servings | Experimental | Other: Community Servings, Other: PedsQL Survey, Other: Nutrition Counseling, Other: SDOH SurveyThe treatment group will receive six months of medically-tailored meals for pediatric Type I Diabetes through Community Servings non-profit organization in addition to standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Participants will have a six-month follow-up period following completion of the medically tailored meals programming. Subjects will complete the PedsQL quality of life surveys, program-specific surveys on medically-tailored meals with Community Servings, and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study. |
| Standard of Care Pediatric Type I Diabetes | Active comparator | Other: PedsQL Survey, Other: Nutrition Counseling, Other: SDOH SurveyThe control group will receive twelve months of standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Subjects will complete the PedsQL quality of life surveys and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and/or registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study. If the subject completes all study procedures, they will have the option to access six months of Community Servings medically-tailored meals provided by the research institution upon completion of the study. |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Current patients of the UMMMC Pediatric Endocrinology Clinic
- Children and Adolescents less than or equal to 17 years of age at the time of enrollment
- Diagnosed with Type 1 Diabetes at least 3 months ago
- Public (MassHealth or Medicaid) Health Insurance
Key exclusion criteria (6 listed)
- Celiac disease or severe gluten allergy
- Congenital, genetic, or chronic comorbidities
- DCF Custody
- Pregnant women
- Prisoners
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 |
|---|---|---|
| Community ServingsParticipants randomized to the intervention group will receive the Community Servings medically-tailored meal plan for the first 6 months after enrollment. The Community Servings plan will provide 10 medically-tailored meals per week, delivered to the participant residence on the day of the week preferred by the participant. Following enrollment, participants will meet with a Community Servings team member to review dietary restrictions. The meals were designed by Registered Dieticians for children and adolescents with Type 1 Diabetes and will be prepared and distributed by the Community Servings team. Participants in the intervention arm will also be asked to complete a survey on the utility of the Community Servings intervention at the conclusion of the program, 6 months after initial enrollment. The survey and responses will be housed in the REDCap. | Other | Community Servings |
| PedsQL SurveyAll participants or their parents will complete a baseline quality of life assessment appropriate for their age group and again at 3 months, 6 months, and at end of follow-up at 12 months. The PedsQL Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. This model integrates multidimensional physical, emotional, social, and school functioning scales and reports total, physical health, and psychological health summary scores. This survey can be completed in person with research staff, over the phone with research staff, or remotely via a link distributed from the REDCap database. Responses will be stored in the REDCap database. | Other | Community Servings, Standard of Care Pediatric Type I Diabetes |
| Nutrition CounselingParticipants will recieve standare-of-care nutrition counseling from a registered dietician with the UMass Pediatric Endocrinology clinic to receive education and review dietary and nutrition recommendations personalized to the patient and management of Type I diabetes. | Other | Community Servings, Standard of Care Pediatric Type I Diabetes |
| SDOH SurveyAll participants or their parents will complete a baseline social driver of health (SDOH) survey at the time of enrollment and again at 3 months, 6 months, and at end of follow-up at 12 months. The SDOH survey is provided for all patients at UMass and evaluates the risk for food, housing, utility, and transportation concerns. This survey can be completed in person with research staff, over the phone with research staff, or remotely via a link distributed from the REDCap database. Responses will be stored in the REDCap database. | Other | Community Servings, Standard of Care Pediatric Type I Diabetes |
Primary outcome
Difference in nutrition-related clinical outcomes
Time frame: 12 months
The primary outcome measure is the difference in clinical outcomes between the control and intervention groups. Nutrition-related outcomes will include growth metrics (Z-score and percentile rank), and height and weight will be combined to report Body Mass Index (BMI) in kg/m^2 metrics.
Difference in Diabetes-related clinical outcomes
Time frame: 12 months
One primary outcome measure is the difference in clinical outcomes between the control and intervention groups. Diabetes outcomes will include changes in insulin dosage (units/mL/day), continuous glucose monitoring metrics (glucose in mg/dL, time spent at range intervals and variability as percentages), and Hemoglobin A1c (percentage).
3 secondary outcomes
Healthcare Utilization
Time frame: 12 months
HRQOL Outcomes
Time frame: 12 months
Medically-tailored Meals Sustainability
Time frame: 12 months
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 25 Sep 2026.
- BackgroundErika Hanson, Sara Raza, Katie Garfield, Erin Mizraki, Hannah Rahim, Jessica Samuels, Carmel Shachar, Emily Broad Leib, Alissa Wassung, and Cate Hensley; Food is Medicine: A State Medicaid Policy Toolkit; Harvard Law School Center for Health Law and Policy Innovation and Food is Medicine Coalition
- Background: PubMed 14684391Drewnowski A, Specter SE. Poverty and obesity: the role of energy density and energy costs. Am J Clin Nutr. 2004 Jan;79(1):6-16. doi: 10.1093/ajcn/79.1.6.
- Background: PubMed 26526240Gundersen C, Ziliak JP. Food Insecurity And Health Outcomes. Health Aff (Millwood). 2015 Nov;34(11):1830-9. doi: 10.1377/hlthaff.2015.0645.
- Background: PubMed 39201842Chobot A, Piona C, Bombaci B, Kaminska-Jackowiak O, Mancioppi V, Passanisi S. Exploring the Continuous Glucose Monitoring in Pediatric Diabetes: Current Practices, Innovative Metrics, and Future Implications. Children (Basel). 2024 Jul 27;11(8):907. doi: 10.3390/children11080907.
- Individual participant dataSharing planned: No
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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.
Lawrence Rhein, MD, MPH principal investigator
UMass Chan Medical School
Arvin Garg, MD, MPH principal investigator
UMass Chan Medical School
Leslie Soyka, MD principal investigator
UMass Chan Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Servings, PedsQL Survey and Nutrition Counseling in people with Type I Diabetes and Pediatrics, run by University of Massachusetts, Worcester 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 25 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 Madeline E French, BS, MBE (5088870106, madeline.french2@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in nutrition-related clinical outcomes (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07535502, which also lists 4 linked publications.
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 25 Sep 2026.