Designing Medically Tailored Meal Interventions: The Food as Medicine for Families (FAME-F) Factorial Randomized Clinical Trial

BACKGROUND: Medically tailored meals (MTM) have unanswered implementation questions. Providing MTM for a specific individual, rather than the entire household, could underdose if food is shared, but household MTM is more costly. Delivery with commercial shippers rather than dedicated drivers may broaden accessibility but could worsen mental health. We sought to test these possibilities. METHODS: 2×2 factorial randomized comparative effectiveness trial (February 2024-May 2025) of adults with control over dietary intake in New England. All participants received 10 MTM per week for 12 weeks, prepared under the supervision of a registered dietitian. Participants were randomly assigned along 2 dimensions: dose (feed the family versus feed the individual) and delivery (dedicated driver versus commercial shipper). The primary dose dimension outcome was the Healthy Eating Index 2020 diet quality score (range, 0-100; higher scores indicating greater adherence to dietary guidelines). The primary delivery dimension outcome was the de Jong Gierveld loneliness scale (range, 0-11; greater scores indicating more loneliness). Intention-to-treat linear regression analyses assessed outcomes at 12 weeks and allowed for interactions between dimensions. RESULTS: Ninety-three participants (mean [SD] age: 57.6 [12.9] years; 67% female; 48.9% non-Hispanic White) were randomized: 46 to feed the family, 47 to feed the individual, to 43 dedicated driver, and 50 to a commercial shipper. For the dose dimension, no significant differences were detected in Healthy Eating Index score (feed the individual: 61.4; feed the family: 62.5, difference: 1.1 [95% CI, -22.6 to 24.9]). For the delivery dimension, no significant differences were detected in loneliness scores (dedicated driver: 7.1, commercial shipper: 6.8; difference, 0.4 [95% CI, -1.5 to 2.2]). CONCLUSIONS: Providing MTM to the entire household does not necessarily improve the focal individual's diet quality, relative to feeding that individual alone. MTM programs could choose which delivery strategy to adopt based on considerations other than participant mental health. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT06160973.