Food is Medicine in Pediatric Patients With Diabetes

University of Massachusetts, Worcester

Status: Not yet enrolling

Conditions: Pediatrics; Type I Diabetes; Food Insecurity

Treatments: Other: PedsQL Survey; Other: Community Servings; Other: SDOH Survey; Other: Nutrition Counseling

Study type: Interventional

Funder types: Other

Identifiers

NCT07535502

STUDY00002969

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

Community Servings

Experimental group

Description:

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.

Treatment:

Other: Nutrition Counseling

Other: SDOH Survey

Other: Community Servings

Other: PedsQL Survey

Standard of Care Pediatric Type I Diabetes

Active Comparator group

Description:

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.

Treatment:

Other: Nutrition Counseling

Other: SDOH Survey

Other: PedsQL Survey