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.
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
recent diagnosis of T1DM (<6 months)
Parallel
Produce prescription
BehavioralProduce 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
BehavioralMedically Tailored Meals: Families will receive 3 semi-prepared medically tailored meal kits and recipes per week x 6 weeks.
Nutrition Coaching
BehavioralNutrition 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.
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.
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.
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.
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.
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
Engagement
Redemption rate and adherence rate.
Percent adherence to the study protocol
adherence to the nutrition coaching protocol
Cost
cost per participant
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Katelyn Fox
Lead sponsor
The Miriam Hospital
Sponsor institution
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