NCT04959487Completed
Changing Health Through Food Support for Diabetes
Food is Medicine: Randomized Trial of Medically-Tailored Food Support for Diabetes Health
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
This is a pragmatic randomized controlled trial (RCT) of Changing Health through Food Support for Diabetes (CHEFS-DM). This pragmatic RCT will leverage Project Open Hand's (POH) real-world programs to test the impact of a six month medically tailored food support and nutrition intervention ("CHEFS-DM") on glycemic control and other cardiometabolic outcomes, investigate the paths through which CHEFS-DM may durably improve health, and assess the economic value of the intervention to society.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 281 (actual)
- First submitted
- 25 Jun 2021
- Start date
- 23 Aug 2021
- Primary completion date
- 5 Feb 2025
- Lead sponsor
- University of California, San Francisco
- Diseases
- Type 2 diabetes
- NCT number
- NCT04959487
What you commit to
- Study type: Interventional
- Participants enrolled: 281
- From 23 Aug 2021 to the primary completion date, 5 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Type-1 diabetes mellitus
- 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.
Lab values
- Individuals with disorders known to affect the accuracy of the HbA1c measure (e.g., end stage renal disease and individuals with known hemoglobinopathies).
Other
- 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.
- 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.
- Individual does not eat any or all of POH's meat meal options and will not eat the vegetarian POH meal option.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Project Open Hand Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.