---
type: source
title: "Medically Tailored Meals Pilot RCT: Null HbA1c Result Despite Intensive Intervention (Maryland 2024)"
author: "Journal of General Internal Medicine (multiple authors)"
url: https://link.springer.com/article/10.1007/s11606-024-09248-x
date: 2024-12-01
domain: health
secondary_domains: []
format: journal-article
status: null-result
priority: high
tags: [medically-tailored-meals, mtm, rct, hba1c, null-result, diabetes, food-as-medicine, pilot-trial]
processed_by: vida
processed_date: 2026-03-18
extraction_model: "anthropic/claude-sonnet-4.5"
extraction_notes: "LLM returned 1 claims, 1 rejected by validator"
---

## Content

Pilot randomized trial of medically tailored meals for low-income adults with type 2 diabetes, published in Journal of General Internal Medicine (2024).

**Study design:**
- 74 adults enrolled, 77% completing data collection
- Demographics: mean age 48 years, 40% male, 77% Black, mean HbA1c 10.3% (severely uncontrolled)
- Intervention: home delivery of 12 medically tailored, frozen meals + a fresh produce bag weekly for 3 months, PLUS individual calls with a registered dietitian monthly for 6 months
- Control: usual care
- Primary outcome: HbA1c at 6 months
- Funding: Robert Wood Johnson Foundation

**Results:**
- Treatment group HbA1c change: -0.7%
- Control group HbA1c change: -0.6%
- Between-group difference: NOT statistically significant
- NOTE: Control group reported more favorable changes in diabetes medications (suggesting control group had more active medication management)

**Why both groups improved:**
- The 6-month period coincided with study enrollment and regular contact with research staff — the study itself may have been therapeutic for both groups (Hawthorne effect)
- Both groups received more attention and healthcare engagement than usual
- The control group's medication adjustments may explain why their HbA1c improved similarly without the food intervention

**Context:**
- This is a PILOT study (underpowered by design for definitive conclusions)
- Baseline HbA1c 10.3% means regression-to-mean is likely for any intervention
- The study provides justification for a larger powered RCT

## Agent Notes

**Why this matters:** This is the most clinically intensive food-as-medicine intervention tested in a controlled design: pre-prepared medically tailored meals PLUS dietitian counseling PLUS produce delivery. If anything works, this should. The null result is not a verdict — it's a pilot — but it complicates the "better interventions fix the problem" hypothesis. Even the most intensive MTM model tested in a controlled setting doesn't reliably improve glycemic control in a 6-month window.

**What surprised me:** The control group showing comparable HbA1c improvement (and MORE medication optimization) suggests that study participation itself — not food delivery — may be driving both groups' improvement. This is the Hawthorne effect at work: any intensive contact program improves outcomes, regardless of the specific content. This is the same issue that plagues behavioral interventions generally.

**What I expected but didn't find:** A positive HbA1c result for the MTM group. I expected that if you deliver pre-prepared meals directly to people's homes (eliminating the food preparation barrier), you'd finally see glycemic improvement. The null result suggests the barrier isn't meal preparation — it may be something else (motivation, medication adherence, social context, stress).

**KB connections:**
- This is the most important new piece of evidence in Session 2
- Directly extends the JAMA Doyle RCT null result to a different, more intensive intervention type
- Challenges the "intervention intensity rescues FIM" hypothesis
- The medication comparison finding (control group more medication-optimized) suggests an important confounder: medical management may be more impactful than food delivery for glycemic control

**Extraction hints:**
- Extractable claim: "Medically tailored meals PLUS dietitian counseling produced null HbA1c improvement in a pilot RCT (Maryland 2024), with the control group showing comparable glycemic improvement through enhanced medication management — suggesting medical management may be more glycemically impactful than food delivery alone"
- The Hawthorne effect observation is important: study participation improves outcomes regardless of intervention; comparing to true usual care (no study contact) would likely show a benefit
- Flag the pilot nature: underpowered, not definitive, but directionally important

**Context:** Robert Wood Johnson Foundation-funded. Published in JGIM (General Internal Medicine), not a food/nutrition journal — reflects the clinical medicine community's engagement with the FIM evidence question. The demographics (77% Black, high-poverty, mean HbA1c 10.3%) are the target population for whom food-as-medicine is most often advocated. If it doesn't work here, the hypothesis has a problem.

## Curator Notes

PRIMARY CONNECTION: Food-as-medicine clinical evidence — the most intensive intervention type (MTM + dietitian) also shows null HbA1c result
WHY ARCHIVED: Critical new evidence that the simulation-vs-RCT gap persists even for the "best" FIM intervention — changes the confidence level for food-as-medicine clinical outcome claims
EXTRACTION HINT: Pair with the JAMA Doyle RCT null result. Two controlled trials, two intervention types (food pharmacy vs. MTM), same null HbA1c finding. This is a pattern, not a single study artifact.


## Key Facts
- Maryland pilot RCT enrolled 74 adults with type 2 diabetes, 77% completed data collection
- Study demographics: mean age 48 years, 40% male, 77% Black, mean baseline HbA1c 10.3%
- Intervention: 12 medically tailored frozen meals + fresh produce bag weekly for 3 months, plus monthly dietitian calls for 6 months
- Treatment group HbA1c change: -0.7%, Control group: -0.6% (not statistically significant)
- Control group reported more favorable diabetes medication changes than treatment group
- Study funded by Robert Wood Johnson Foundation
- Published in Journal of General Internal Medicine 2024
