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Meals on prescription: study tests food as diabetes medicine

NCT ID NCT04264572

Disease control Sponsor: Thomas Jefferson University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether providing medically tailored meals and nutrition counseling via telehealth can improve blood sugar control in adults with poorly controlled type 2 diabetes. 600 participants were randomly assigned to receive meals, meals plus counseling, or usual care. The main goal was to see if these interventions lowered hemoglobin A1C levels over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
medically tailored meals and telehealth nutrition counseling
What this could lead to
If successful, this approach could become a standard, reimbursed part of diabetes care, helping patients better manage their blood sugar through diet.
What could go wrong
This is a completed pragmatic trial, so results are available. However, the intervention may not work for everyone, and long-term benefits beyond the study period are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

600 people

The number who actually took part.

Started

Jan 2020

Finished

May 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Have type 2 diabetes mellitus (DM) 2. Are 18 years or older of age 3. English speaking 4. Are a patient in the ED or inpatient at TJUH or Methodist Hospital 5. Have a HbA1c \>8% as assessed during enrollment screening 6. Have a PCP or Endocrine provider 7. Have access to a device (e.g., smartphone, tablet, computer with WiFi) that can support video visits 8. Have access to an email account (either own or family member) 9. Are able to keep food fresh for a week after delivery (e.g., not homeless) and reheat food using a microwave or oven 10. Live in the MANNA service area Exclusion Criteria: 1. Have type 1 DM (to reduce confounding related to underlying differences in pathophysiology and primary treatment approaches (lifestyle change vs medication regimens) between type 1 and type 2 DM) 2. Pregnant, planning to be pregnant, or currently breastfeeding, as these patients have unique nutritional requirements outside the MNT curriculum 3. Does not eat by mouth (i.e. receives tube feeds or total parenteral nutrition \[TPN\]) 4. History of severe gastroparesis 5. Has a life expectancy of less than one year, per clinician 6. Inability to provide informed consent 7. Psychiatric co-morbidity that would preclude study participation 8. Major communication barriers such as visual or hearing impairment that would compromise the ability to participate in a video visit 9. Lives in or is being discharged to a facility (incarcerated, IP rehab, nursing home) 10. Currently receiving MTM from MANNA or another provider 11. Have life threatening food allergies 12. Currently participating in DM-I or PREVENT study 13. Has 3 or more ED visits for alcohol or other substance use in past month

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

Contacts and locations

Locations

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.