Healthy meals as medicine: new study tests food support for diabetes
NCT ID NCT04959487
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
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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
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281 people
The number who actually took part.
- Started
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Aug 2021
- Finished
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Jun 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Project Open Hand
San Francisco, California, 94109, United States
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