Clinical trial NCT04959487: Changing Health Through Food Support for Diabetes
Official title: Food is Medicine: Randomized Trial of Medically-Tailored Food Support for Diabetes Health
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Food Insecurity
Keywords: Food security
Diabetes Mellitus
Food assistance
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Project Open Hand
First posted: 2021-07-13
Enrollment: 281
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants (n=440\*) will be randomized to the intervention (n=220\*) or control (n=220\*) arms, stratified by county (San Francisco vs. Alameda County) and poor diabetes control (A1c \< 9%, vs. ≥ 9%). The intervention consists of providing diabetes-tailored food support and nutritional education (two sessions of individual counseling and four session of in-group diabetes-tailored nutrition education sessions) over six months to patients with type 2 diabetes.

\*Update: Due to COVID-era challenges, NIH approved changes to the study in January 2024 including a reduced sample size (at least n=246) and reduced measures and procedures to ease participant burden (see updated Protocol/SAP Version 2, Section 7, for details).
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: CHEFS-DM is a six-month intervention providing a diabetes-tailored diet meeting approximately 75% of daily energy requirements and designed based on American Diabetes Association (ADA) guidelines, together with diabetes nutritional education provided by registered dietitians. In this pragmatic RCT, investigators propose to rigorously evaluate the intervention among 440\* low-income adults with Type 2 Diabetes Mellitus (T2DM) recruited from networks of safety net clinics in San Francisco and Alameda counties, California.

Participants will be randomized 1:1 to the intervention (n=220\*) versus control (n=220\*), using a parallel design. The study aims are as follows:

Aim 1: To determine the impact of CHEFS-DM on glycemic control and other cardiometabolic outcomes.

Aim 2: To determine the impact of CHEFS-DM on intermediate outcomes that may mediate any impact of CHEFS-DM on T2DM health.

Participant will be followed for 6 months (control arm) and 12 months (intervention arm) with structured interviews, anthropometric assessments, 24-hour dietary recalls, blood pressure measurements, blood draws, and semi structured interviews. Follow-up will be broken up into two phases. From baseline to six months, researchers will implement the CHEFS-DM intervention and follow both intervention and control arm participants (n=440\*). After the end of the six-month follow-up, the intervention arm will transition to receiving standard POH services comprising 33% to 67% of daily energy requirements depending on health status, and will be followed for an additional six months, in order to assess the extent to which any health benefits are sustained at 12 months (n=220\*). Hence, the control arm will be followed for six months and participate in two sets of assessments (baseline and at six months), and the intervention arm will be followed for 12 months and participate in three sets of assessments (baseline, six months, and twelve months).

\*Update: Due to COVID-era challenges, NIH approved changes to the study in January 2024 including a reduced sample size (at least n=246) and reduced measures and procedures to ease participant burden (see updated SAP Version 2, Section 7, for details).

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.

Primary outcomes:
measure: Change in Hemoglobin A1c from baseline to six months by study arm
timeFrame: Baseline and six months
measure: Change in food insecurity severity from baseline to six months by study arm
timeFrame: Baseline and six months
Secondary outcomes:
measure: Change in the proportion of participants with low and very low food security
timeFrame: Baseline and six months
measure: Change in proportion of participants with glucose control by study arm.
timeFrame: Baseline and six months
measure: Change in systolic and diastolic blood pressure from baseline to six months
timeFrame: Baseline and 6 months
measure: Change in medication adherence from baseline to six months by study arm
timeFrame: Baseline and six months
measure: Acute health care utilization from baseline to six month by study arm
timeFrame: Baseline and six months
measure: Hospital admissions from baseline to six months by study arm
timeFrame: Baseline to six months
measure: Missed outpatient visits from baseline to six months by study arm
timeFrame: Baseline to six months
measure: Change in health-related quality of life scores from baseline to six months by study arm
timeFrame: Baseline and six months
measure: Change in body mass index (BMI) from baseline to six months by study arm
timeFrame: Baseline and six months
measure: Change in healthy eating index score 2015 (HEI-2015) from baseline to six months by study arm.
timeFrame: Baseline and six months
measure: Change in depressive symptoms from baseline to six months by study arm
timeFrame: Baseline and six months
measure: Change in diabetes distress scale from baseline to six months by study arm
timeFrame: Baseline and six months
measure: Change in diabetes self-efficacy from baseline to six months by study arm
timeFrame: Baseline and six months
Other outcomes:
measure: Durability of HbA1c values from six months to twelve months in the intervention arm.
timeFrame: Six and twelve months
measure: Durability in scores of food security from six to twelve months in the intervention arm.
timeFrame: Six and twelve months
Locations:
city: San Francisco
country: United States
facility: Project Open Hand
state: California
Study officials:
affiliation: University of California, San Francisco
name: Kartika Palar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Berkowitz SA, Terranova J, Randall L, Cranston K, Waters DB, Hsu J. Association Between Receipt of a Medically Tailored Meal Program and Health Care Use. JAMA Intern Med. 2019 Jun 1;179(6):786-793. doi: 10.1001/jamainternmed.2019.0198.
citation: Seligman HK, Jacobs EA, Lopez A, Tschann J, Fernandez A. Food insecurity and glycemic control among low-income patients with type 2 diabetes. Diabetes Care. 2012 Feb;35(2):233-8. doi: 10.2337/dc11-1627. Epub 2011 Dec 30.
citation: Seligman HK, Jacobs EA, Lopez A, Sarkar U, Tschann J, Fernandez A. Food insecurity and hypoglycemia among safety net patients with diabetes. Arch Intern Med. 2011 Jul 11;171(13):1204-6. doi: 10.1001/archinternmed.2011.287. No abstract available.
citation: Marpadga S, Fernandez A, Leung J, Tang A, Seligman H, Murphy EJ. Challenges and Successes with Food Resource Referrals for Food-Insecure Patients with Diabetes. Perm J. 2019;23:18-097. doi: 10.7812/TPP/18-097.