Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Produce prescription, Medically tailored meal kits, Nutrition Coaching.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes (T1D), Food Insecurity. Basic parameters: 5 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes
Overview
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.
Interventions
- 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). - 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
Primary outcome measures
- Feasibility [Time frame: baseline, pre-intervention and immediately after the intervention]
- Acceptability [Time frame: immediately after the intervention]
Secondary outcome measures (3)
- Change in Diet quality [Time frame: baseline, pre-intervention and immediately after the intervention]
- Change in Glucose Stability [Time frame: baseline, pre-intervention and immediately after the intervention]
- Change in Food Security [Time frame: baseline, pre-intervention and immediately after the intervention]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Hasbro Children's Hospital — Providence
Identifiers
NCT: NCT07590817 · 25FIMPG1492233