Food is Medicine in Pediatric Patients With Diabetes

Официальное название

The Effect of a Novel Food is Medicine Program on Outcomes in Pediatric Patients With Diabetes: A Randomized Controlled Trial

Обзор

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.

Вмешательства

• Другое Community Servings
  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 child
• Другое PedsQL Survey
  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, phy
• Другое Nutrition Counseling
  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.
• Другое SDOH Survey
  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

Первичные конечные точки

• Difference in nutrition-related clinical outcomes [Срок оценки: 12 months]
• Difference in Diabetes-related clinical outcomes [Срок оценки: 12 months]

Вторичные конечные точки (3)

• Healthcare Utilization [Срок оценки: 12 months]
• HRQOL Outcomes [Срок оценки: 12 months]
• Medically-tailored Meals Sustainability [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Celiac disease or severe gluten allergy
• Congenital, genetic, or chronic comorbidities
• DCF Custody
• Pregnant women
• Prisoners
• Non-English speaking subjects

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• UMass Memorial Children's Medical Center — Worcester

Публикации

• 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. PMID 14684391
• Gundersen C, Ziliak JP. Food Insecurity And Health Outcomes. Health Aff (Millwood). 2015 Nov;34(11):1830-9. doi: 10.1377/hlthaff.2015.0645. PMID 26526240
• Chobot 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. PMID 39201842

Идентификаторы

NCT: NCT07535502 · STUDY00002969

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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