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

NCT07590817 | Not Yet Recruiting

• 1 other identifier: 25FIMPG1492233
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Food Insecurity; Type 1 Diabetes (T1D)

Keywords

Type 1 Diabetes; Food Insecurity; Food is Medicine; Medically Tailored Meals; Produce Prescriptions; Nutrition Education

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Diet quality

  baseline, pre-intervention and immediately after the intervention

• Change in Glucose Stability

  baseline, pre-intervention and immediately after the intervention

• Change in Food Security

  baseline, pre-intervention and immediately after the intervention

Other Outcomes (3)

• Engagement

  through study completion, an average of 6 weeks

• Percent adherence to the study protocol

  through study completion, an average of 6 weeks

• Cost

  through study completion, an average of 6 weeks

Study Arms (2)

Medically tailored meal kits + nutrition coaching

EXPERIMENTAL

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; Behavioral: Nutrition Coaching

Produce prescription + nutrition coaching

ACTIVE COMPARATOR

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: Produce prescription; Behavioral: Nutrition Coaching

Interventions

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).

Produce prescription + nutrition coaching

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.

Medically tailored meal kits + nutrition coaching

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.

Medically tailored meal kits + nutrition coaching; Produce prescription + nutrition coaching

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• recent diagnosis of T1DM (\<6 months)

Sponsors & Collaborators

• Katelyn Fox: lead

Study Sites (1)

Hasbro Children's Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: May 15, 2026
• Study Start (Estimated): May 30, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 06/26/2026
• Access Criteria: Researchers through the openICPSR repository.

Locations

US (1)