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NCT Number: NCT07590817

Pilot of 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.

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Key information

Conditions

Type 1 Diabetes (T1D) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Food Insecurity Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location contact

Katelyn Fox, PhD

CONTACT

[email protected]

4017870821 ext. 401-793-8251

Lisa Swartz Topor, MD

SUB_INVESTIGATOR

Rivkah Cohen

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Produce prescription

Behavioral

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).

Medically tailored meal kits

Behavioral

Medically Tailored Meals: Families will receive 3 semi-prepared medically tailored meal kits and recipes per week x 6 weeks.

Nutrition Coaching

Behavioral

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.

Primary outcomes

  1. Feasibility

    Time frame: 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.

  2. Acceptability

    Time frame: 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.

Secondary outcomes

  1. Change in Diet quality

    Time frame: 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.

  2. Change in Glucose Stability

    Time frame: 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.

  3. Change in Food Security

    Time frame: 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

Other outcomes

  1. Engagement

    Time frame: through study completion, an average of 6 weeks

    Redemption rate and adherence rate.

  2. Percent adherence to the study protocol

    Time frame: through study completion, an average of 6 weeks

    adherence to the nutrition coaching protocol

  3. Cost

    Time frame: through study completion, an average of 6 weeks

    cost per participant

Sponsors and collaborators

Lead sponsor

Katelyn Fox

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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