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

12 mei 2026 bijgewerkt door: Katelyn Fox

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

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

12

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Rhode Island
      • Providence, Rhode Island, Verenigde Staten, 02903
        • Hasbro Children's Hospital
        • Contact:
        • Contact:
          • Rivkah Cohen
        • Onderonderzoeker:
          • Lisa Swartz Topor, MD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • recent diagnosis of T1DM (<6 months)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Medically tailored meal kits + nutrition coaching
Medically Tailored Meals: Each family in this arm will receive medically tailored meal kits (3 semi-prepared meals and recipes per week x 6 weeks).Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
Gedragsmatig: Medically tailored meal kits
Medically Tailored Meals: Families will receive 3 semi-prepared medically tailored meal kits and recipes per week x 6 weeks.
Gedragsmatig: Nutrition Coaching
Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
Actieve vergelijker: Produce prescription + nutrition coaching

Produce prescriptions: Each family in this arm will receive weekly boxes of fresh produce. Similar to the USDA's TEFAP (The Emergency Food Assistance Program), boxes include 10-12 lbs of fresh fruits and vegetables per month (adjustable based on family size). Boxes will also include recipes and examples of how to incorporate the produce into family meals

Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
Gedragsmatig: Nutrition Coaching
Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
Gedragsmatig: Produce prescription
Produce prescriptions: Weekly boxes of fresh produce. Similar to the USDA's TEFAP (The Emergency Food Assistance Program), boxes include 10-12 lbs of fresh fruits and vegetables per month (adjustable based on family size).

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Feasibility
Tijdsspanne: baseline, pre-intervention and immediately after the intervention
Feasibility will be assessed using the following criteria: Recruitment of >50% of families screened eligible, retention of > 65% of randomized families at follow-up, >50% adherence to coaching protocol, and >50% preparation of the prescribed meals.
baseline, pre-intervention and immediately after the intervention
Acceptability
Tijdsspanne: immediately after the intervention
Acceptability will be assessed using the following criteria: caregiver report of target child consuming prepared foods more than half of the time, and a net promotor score >20.
immediately after the intervention

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Diet quality
Tijdsspanne: baseline, pre-intervention and immediately after the intervention
The 24-hour dietary recalls will be collected by masked assessors using Nutrition Data System for Research (NDSR), a computer-based software application that facilitates the collection of recalls in a standardized fashion, using a multiple-pass interview approach to improve participant recall.51 Healthy Eating Index (HEI-2020) will be calculated using the NCI per person algorithm.HEI-2020 is scored on a scale from 0-100 with higher scores reflecting better diet quality.
baseline, pre-intervention and immediately after the intervention
Change in Glucose Stability
Tijdsspanne: baseline, pre-intervention and immediately after the intervention
Glucose stability will be assessed using time in range (TIR), using CGM data. We will calculate TIR as the percent of time an individual spends in a target BG range (% of readings with-in 70-180 mg/dL). TIR is a strong indicator of DM management and future CVD risk.
baseline, pre-intervention and immediately after the intervention
Change in Food Security
Tijdsspanne: baseline, pre-intervention and immediately after the intervention
United States Department of Agriculture Food Security Survey Module (USDA FSSM) 18-Item. This survey is score on a scale of 0-18 with higher scores indicating higher food insecurity. Categorically For households with one or more children a Raw score zero= High food security, Raw score 1-2=Marginal food security, Raw score 3-7=Low food security, Raw score 8-18=Very low food security
baseline, pre-intervention and immediately after the intervention

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Engagement
Tijdsspanne: through study completion, an average of 6 weeks
Redemption rate and adherence rate.
through study completion, an average of 6 weeks
Percent adherence to the study protocol
Tijdsspanne: through study completion, an average of 6 weeks
adherence to the nutrition coaching protocol
through study completion, an average of 6 weeks
Cost
Tijdsspanne: through study completion, an average of 6 weeks
cost per participant
through study completion, an average of 6 weeks

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Katelyn Fox

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 mei 2026

Primaire voltooiing (Geschat)

30 juni 2026

Studie voltooiing (Geschat)

30 juni 2026

Studieregistratiedata

Eerst ingediend

30 september 2025

Eerst ingediend dat voldeed aan de QC-criteria

12 mei 2026

Eerst geplaatst (Werkelijk)

15 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

12 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 25FIMPG1492233

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Data to be generated during this study include surveys, interviews, 24-hour dietary recalls, participant height, weight, blood pressure, and continuous glucose monitor readings. Once the data collection for this study has concluded, all direct respondent identifiers (e.g., names and addresses) will be removed from the data and a key maintained in a separate and separately stored and encrypted file for future contact purposes. To ensure participant consent for data sharing, IRB paperwork and informed consent documents will include language describing plans for data management and sharing of data, describing the motivation for sharing, and explaining that personal identifying information will be removed. Study respondents will be asked to consent to data collection and de-identified data sharing with the wider research community via deposit in the openICPSR repository.

IPD-tijdsbestek voor delen

06/26/2026

IPD-toegangscriteria voor delen

Researchers through the openICPSR repository.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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