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Healthy meals as medicine: new study tests food support for diabetes

NCT ID NCT04959487

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether providing six months of diabetes-tailored meals and nutrition counseling can improve blood sugar control and reduce food insecurity in adults with type 2 diabetes. 281 participants received either the food support plus counseling or usual care. The main goals were to see changes in HbA1c (a measure of blood sugar) and food security scores.

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 food support and nutritional counseling
What this could lead to
If it works, this could show that providing healthy food and nutrition advice is an effective way to help manage type 2 diabetes and reduce food insecurity.
What could go wrong
This is a completed trial, but results may not apply to everyone. The intervention is short-term (6 months), and long-term benefits or cost savings are not yet proven.

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

281 people

The number who actually took part.

Started

Aug 2021

Finished

Jun 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: * Confirmed diagnosis of T2DM confirmed by medical or laboratory records. For T2DM, any of the following criteria will be considered (from the American Diabetes Association): * glycated hemoglobin (HbA1c) ≥6.5%, or * fasting plasma glucose of ≥126, or * a 2-hour plasma glucose level of 200 or higher during a 75 g oral glucose tolerance test, or * a random plasma glucose of 200 or higher in patients with symptoms of hyperglycemia * Age ≥18 years. * Screening positive for food insecurity (at least one positive answer) in the previous 6 months assessed using the 6-item version of the US Household Food Security Survey Module (US Department of Agriculture), or has household income \<200% of the federal poverty level. * English or Spanish language fluency. * Adequate cognitive and hearing capacity to consent and complete study measures. * Reside in Alameda County or San Francisco County. Exclusion Criteria: * Type-1 diabetes mellitus * Individuals with disorders known to affect the accuracy of the HbA1c measure (e.g., end stage renal disease and individuals with known hemoglobinopathies). * Inability to attend the educational workshops. * Inability to schedule baseline assessments and/or blood draw after repeated requests. * Pregnant individuals, or individuals planning to get pregnant within 6 months, or are lactating, or are postpartum less than 6 months. * Current POH clients, past POH clients who stopped services less than 6 months prior, or past or present participants in other POH medically tailored meals studies. * Does not have access to food storage, including a refrigerator and freezer to safely keep food. * Does not have access to facilities to reheat and prepare meals using Project Open Hand food. * Anticipates moving out of study area of Alameda and San Francisco Counties in the next 6 months. * Receives more than 1 meal per day from a free food support resource or agency. * Allergic to or will not eat eggs, soy, wheat, nuts, seeds or seed oils, or other foods commonly included among ingredients in POH meals. * Allergic to dairy products, or unable to tolerate any dairy products including milk, yogurt and cheese. * Individual does not eat any or all of POH's meat meal options and will not eat the vegetarian POH meal option.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Project Open Hand

    San Francisco, California, 94109, United States

More trials for these conditions

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