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NCT07590817Not yet recruiting

Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes

Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes

Source: ClinicalTrials.gov · Last updated 15 May 2026

Brief summary (registry, in English)

Study Design: This two-arm parallel trial will randomize 12 families to receive 6-weeks of medically tailored meals or produce prescriptions. Both groups will receive nutrition coaching, weekly during the intervention. The hypothesis is that both interventions to have a positive impact on food security and fruit and vegetable intake. However, medically tailored meals also reduce the logistic barriers of planning, preparing, and calculating the carbohydrate content of nutritionally balanced meals essential for DM management. Therefore, the medically tailored meal intervention will result in greater improvements in the co-primary outcomes of diet quality and glucose stability after the intervention.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
12 (estimated)
First submitted
30 Sept 2025
Start date
30 May 2026
Primary completion date
30 Jun 2026
Lead sponsor
Katelyn Fox
NCT number
NCT07590817

What you commit to

  • Study type: Interventional
  • Planned participants: 12
  • From 30 May 2026 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • recent diagnosis of T1DM (\<6 months)

Who the study is looking for

  • Families of school-age children (ages 5-12 years) with T1DM and food insecurity
  • fluent in English or Spanish.
  • child uses a continuous glucose monitor (CGM)
  • willing to provide consent for the research team to access CGM data

Age in the registry: 5 years to 12 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hasbro Children's Hospital
Coordinator of this site? Confirm its status
ProvidenceUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.