Medically Tailored Meals for Pediatric Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if medically tailored meal plans can help children and teens with Type 1 Diabetes manage their condition more effectively. The focus is on those who may struggle with food security or access issues. Participants will either receive these meals as part of the Food is Medicine Programming, along with their usual care, or continue with standard care alone. Children who have had Type 1 Diabetes for at least three months and are patients at UMass Pediatric Endocrinology Clinic may be suitable candidates. The study will track changes in their health and quality of life over time. As an unphased trial, it offers a unique opportunity to contribute to understanding how tailored nutrition can improve diabetes management.
What prior data suggests that medically tailored meals are safe for pediatric Type 1 Diabetes patients?
Research has shown that meals specifically designed for medical needs are generally safe and beneficial for people with diabetes. Studies have found that most participants gained better access to healthy food, which increased their food security and reduced stress about managing diabetes.
Evidence suggests these meals can improve diet quality and help control blood sugar levels. For instance, one study found that participants' diet quality scores improved significantly. Additionally, people reported feeling less stressed and experienced fewer hospital visits.
While specific side effects weren't mentioned, the positive health outcomes indicate that these meals are well-tolerated. Overall, these meals can be a safe and helpful addition to diabetes care.12345Why are researchers excited about this trial?
Researchers are excited about the "Food is Medicine" programming for pediatric Type 1 Diabetes because it introduces medically-tailored meals as a unique intervention. Unlike the standard of care, which typically focuses on insulin management and dietary advice, this approach personalizes nutrition to meet the specific health needs of each child. By providing meals specifically crafted for diabetes management, this method aims to improve blood sugar control and overall quality of life in a more holistic way. The integration of tailored nutrition with standard endocrinology care might pave the way for more comprehensive diabetes management strategies.
What evidence suggests that Food is Medicine Programming might be an effective treatment for pediatric Type 1 Diabetes?
This trial will compare the effects of medically tailored meals with standard-of-care treatment for pediatric Type 1 Diabetes. Studies have shown that meals designed for medical needs can improve health for individuals with long-term conditions like diabetes. These meals promote better eating habits and reduce food insecurity, ensuring access to healthy food. Research indicates that recipients of these meals often experience fewer instances of low blood sugar and manage their diabetes more effectively. In some programs, participants reported health improvements while following these meal plans. By providing meals tailored to specific health needs, individuals can better manage their diabetes and enhance their overall quality of life.34567
Who Is on the Research Team?
Lawrence Rhein, MD, MPH
Principal Investigator
UMass Chan Medical School
Leslie Soyka, MD
Principal Investigator
UMass Chan Medical School
Arvin Garg, MD, MPH
Principal Investigator
UMass Chan Medical School
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants in the experimental group receive six months of medically-tailored meals in addition to standard-of-care treatment and nutrition counseling
Follow-up
Participants are monitored for safety and effectiveness after treatment, including completion of quality of life and health risk surveys
Optional Extension
Participants in the control group have the option to access six months of Community Servings medically-tailored meals after completing the study
What Are the Treatments Tested in This Trial?
Interventions
- Food is Medicine Programming
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Massachusetts, Worcester
Lead Sponsor
Citations
Narrative review: food as medicine across the pediatric age ...
Data from adult and population-level interventions provide evidence that FAM interventions positively impact diet quality, food security, health outcomes, and ...
Designing Medically Tailored Meal Interventions: The Food ...
WHAT IS KNOWN. •. Medically tailored meals (MTM) can improve diet quality and health outcomes. •.
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uhccommunityandstate.com
uhccommunityandstate.com/content/articles/nutrition-as-intervention-advancing-food-is-medicine-for-chronic-disease-managementAdvancing food is medicine for chronic disease management
How food as medicine programs address food insecurity and improve diabetes outcomes through medically tailored meals, nutrition support and
Dietary, food security and diabetes outcomes associated ...
Modest improvements in dietary intake, food security status, and diabetes management were observed in 43% of studies; however, most were not ...
Health outcomes reported by healthcare providers and clients ...
We found evidence that participation in MANNA's MTM program was associated with favorable health outcomes for clients with serious illness and nutritional risk.
Impact of Medically Tailored Meals on Clinical Outcomes ...
Data collected on 72% of those getting the intervention showed significant improvements in food security, as well as reduced diabetes distress, ...
Research In-Process
Primary Outcomes Evaluated Effects of the MTM stepdown pilot intervention on participant health outcomes and behavior including dietary consumption, nutrition ...
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