Changing Health Through Food Support for Diabetes

Completed · Not applicable

Conditions studied: Type 2 Diabetes, Food Insecurity

In brief

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.

Key facts

Study ID

NCT04959487

Run by

University of California, San Francisco

People needed

281

Starts

2021-08-23

Expected to finish

2025-06-12

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Project Open Hand — San Francisco, California, United States

Full record on ClinicalTrials.gov

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