Changing Health Through Food Support for Diabetes (CHEFS-DM)
Type 2 Diabetes, Food Insecurity
About this trial
This is an interventional treatment trial for Type 2 Diabetes focused on measuring Food security, Diabetes Mellitus, Food assistance
Eligibility Criteria
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.
Sites / Locations
- Project Open HandRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Standard of care
Food support and nutrition education
Control participants will receive standard of care as offered by clinical partners to all T2DM patients, including referral to nutritional counseling, T2DM support groups, and participation in local diabetes self-management programs. Control participants are also often provided referral information for locally available food support services in the region that provide diabetes-appropriate foods. At the end of follow up, the control arm will receive similar services from POH to what the intervention arm received during the intervention, regardless POH eligibility criteria (6 months of DM-tailored food support to meet 67% of their daily requirements, video recording of the 4 CHEFS-DM education classes, and access to a POH dietitian at their request).
The intervention entails two components: 1) food support that consists of weekly medically tailored meals and healthy groceries that on average covers 75% of daily energy requirements from baseline to six months and 2) diabetes-tailored nutritional education that consists of two individual counseling sessions with a Registered dietitian and four group education sessions.