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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Food Insecurity; Type 1 Diabetes (T1D)
• Intervention / Treatment: Behavioral: Medically tailored meal kits; Behavioral: Nutrition Coaching; Behavioral: Produce prescription

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Hasbro Children's Hospital
      • Contact: Katelyn Fox, PhD; Phone Number: 401-793-8251 4017870821; Email: katelyn_fox@brown.edu
      • Contact: Rivkah Cohen
      • Sub-Investigator: Lisa Swartz Topor, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Medically tailored meal kits; Medically Tailored Meals: Families will receive 3 semi-prepared medically tailored meal kits and recipes per week x 6 weeks.; Behavioral: 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.
Active Comparator: 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.	Behavioral: 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.; Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Diet quality	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	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	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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement	Redemption rate and adherence rate.	through study completion, an average of 6 weeks
Percent adherence to the study protocol	adherence to the nutrition coaching protocol	through study completion, an average of 6 weeks
Cost	cost per participant	through study completion, an average of 6 weeks

Collaborators and Investigators

• Sponsor: Katelyn Fox

Study record dates

Study Major Dates

• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: September 30, 2025
• First Submitted That Met QC Criteria: May 12, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Type 1 Diabetes; Food Insecurity; Nutrition Education; Medically Tailored Meals; Food is Medicine; Produce Prescriptions
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 25FIMPG1492233

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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 Sharing Time Frame: 06/26/2026
• IPD Sharing Access Criteria: Researchers through the openICPSR repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No