Changing Health Through Food Support for Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

281 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-23

Study Completion Date

2025-06-12

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Type 2 Diabetes Food Insecurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Single (Investigator) The investigator(s) reviewing the analyses of the data will be masked to whether participants were in the intervention or control arm.

Study Groups

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Standard of care

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).

Group Type NO_INTERVENTION

No interventions assigned to this group

Food support and nutrition education

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.

Group Type EXPERIMENTAL

Food support

Intervention Type OTHER

1\. Diabetes-tailored food support. Project Open Hand will provide intervention participants six months of supplemental food support meeting on average 75% of their daily energy requirements. Food support will consist of a mix of meals tailored for T2DM, and T2DM-healthy groceries, consistent with American Diabetes Association (ADA) guidelines for diabetes healthy diets under the responsibility of a registered dietitian.

Nutritional Counseling and education

Intervention Type OTHER

2\. Nutritional counseling and education: The registered dietitian will provide individual nutritional counseling two times (at baseline and month 5-6) during the intervention. In addition, group-based DM nutrition education will be conducted over four 1-hour-long sessions. The nutrition education will be conducted by a POH dietitian, and the curriculum will be consistent with published diabetes self- management education principles, utilizing effective strategies in lower wealth, lower literacy populations.

Interventions

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Food support

1\. Diabetes-tailored food support. Project Open Hand will provide intervention participants six months of supplemental food support meeting on average 75% of their daily energy requirements. Food support will consist of a mix of meals tailored for T2DM, and T2DM-healthy groceries, consistent with American Diabetes Association (ADA) guidelines for diabetes healthy diets under the responsibility of a registered dietitian.

Intervention Type OTHER

Nutritional Counseling and education

2\. Nutritional counseling and education: The registered dietitian will provide individual nutritional counseling two times (at baseline and month 5-6) during the intervention. In addition, group-based DM nutrition education will be conducted over four 1-hour-long sessions. The nutrition education will be conducted by a POH dietitian, and the curriculum will be consistent with published diabetes self- management education principles, utilizing effective strategies in lower wealth, lower literacy populations.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No