Nutrition Intervention for Diabetes

(CHEFS-DM Trial)

Overseen By Elizabeth Murphy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Type-1 diabetes, Renal disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a six-month program of medically tailored meals and nutrition education can help people with type 2 diabetes improve blood sugar control and overall health. Participants in the experimental group will receive weekly meals and groceries that meet most of their daily energy needs, along with personalized and group nutrition sessions. The trial seeks individuals with type 2 diabetes who have recently experienced food insecurity and live in Alameda or San Francisco County. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance diabetes care and support for those facing food insecurity.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this nutrition intervention is safe for diabetes patients?

Research has shown that meals designed for medical needs and nutrition education are generally safe and well-tolerated. Studies have found that these meals can help manage type 2 diabetes without major side effects by providing healthy, balanced meals tailored to individual dietary needs.

Regarding nutrition counseling and education, research indicates it effectively improves health for people with diabetes. This involves guidance from dietitians and group education sessions. These methods have not been linked to any major negative effects, making them safe options for managing diabetes.

Overall, both parts of the treatment have demonstrated good safety records, with no serious side effects reported in previous research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the nutrition intervention for diabetes because it offers a comprehensive approach combining tailored food support and personalized nutritional education. Unlike standard treatments that primarily focus on medication and general dietary advice, this approach provides weekly medically tailored meals and healthy groceries covering about 75% of daily energy needs. Additionally, it incorporates personalized counseling sessions with a registered dietitian and group education, which can empower patients with type 2 diabetes to manage their condition more effectively. This holistic strategy not only addresses nutritional needs but also aims to equip patients with knowledge and support, potentially leading to better long-term health outcomes.

What evidence suggests that this trial's treatments could be effective for diabetes?

Studies have shown that specially prepared meals can greatly improve health for people with type 2 diabetes. One study found that these meals reduced the number of people struggling to afford food from 53% to 17% in just three months. Another study showed that these meals are linked to better health and might help lower healthcare costs. In this trial, participants in the "Food support and nutrition education" arm will receive weekly medically tailored meals and diabetes-specific nutritional education. Learning about nutrition and receiving advice from dietitians have also proven effective. Research indicates that advice from dietitians and group classes helps people with diabetes control their blood sugar and improve their overall health. Both specially prepared meals and nutrition education offer promising ways to manage diabetes. ^{1 2 4 6 7}

Who Is on the Research Team?

Kartika Palar, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults over 18 living in Alameda or San Francisco County with Type 2 Diabetes, who are food insecure or have low income. They must speak English or Spanish and be able to attend educational workshops. People can't join if they're pregnant, lactating, planning to move soon, already receiving multiple free meals daily, lack meal prep facilities, have certain health conditions affecting the study's measures or eat a diet incompatible with the provided meals.

Inclusion Criteria

Reside in Alameda County or San Francisco County

I can understand and respond to study requirements.

I have experienced food insecurity or my income is below 200% of the federal poverty level in the last 6 months.

Exclusion Criteria

I don't have the means to heat and prepare meals.

You are currently receiving services from POH, or you have received services from POH in the past 6 months, or you have participated in other POH medically tailored meals studies.

Anticipates moving out of study area of Alameda and San Francisco Counties in the next 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored food support and nutrition education for diabetes management

6 months

Weekly food support and educational sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (baseline, 6 months, 12 months)

Extension

Intervention arm participants receive standard POH services to assess sustained health benefits

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Food support
• Nutritional Counseling and education

Trial Overview The CHEFS-DM program is being tested for its effectiveness on improving blood sugar control and other heart-related health outcomes in people with Type 2 Diabetes through medically tailored food support and nutrition education over six months. The study will also evaluate how this intervention could lead to lasting health benefits and its economic impact.

How Is the Trial Designed?

Group I: Food support and nutrition education Experimental Treatment 2 Interventions

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 II: Standard of care Active Control 1 Intervention

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).

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Project Open Hand

Collaborator

Trials

4

Recruited

740+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Project Open Hand

Collaborator

Trials

5

Recruited

820+

Published Research Related to This Trial

The activity-based personalized nutrition education (APNE) program significantly improved fasting blood glucose, postprandial blood glucose, and glycated hemoglobin levels in middle-aged and older patients with type 2 diabetes after 3 months, while the control group showed no such improvements.

Participants in the APNE group not only adhered more closely to a balanced diet but also made healthier food choices, such as reducing high-fat food intake and increasing consumption of fruits and vegetables, demonstrating the program's effectiveness in changing dietary behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Activity-Based Personalized Nutrition Education on Dietary Behaviors and Blood Parameters in Middle-Aged and Older Type 2 Diabetes Korean Outpatients. Yang, SH., Chung, HK., Lee, SM.[2020]

The article outlines dietary treatment strategies for diabetes, emphasizing nutritional recommendations for prevention and management tailored to different types of diabetes as per the American Diabetes Association guidelines.

It highlights the importance of Therapeutic Education for individuals with diabetes and their families, focusing on educational objectives and strategies to improve adherence to dietary treatments, as recommended by the European Association for the Study of Diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Medical nutritional therapy and therapeutic patient education in diabetes]. Jansà, M., Murillo, S., Vidal, M.[2011]

The nutrient-based diet guide method was found to be as easy to use as the food-group exchange lists method for menu planning in individuals with noninsulin-dependent diabetes, with 97 out of 105 participants completing the workshops and 83 attending the 6-month follow-up.

Participants using the diet guide method showed significantly greater improvements in nutrition knowledge retention compared to those using the exchange lists method, with a 24% increase in knowledge at 3 months versus 15% for the exchange group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Educating patients with diabetes: comparison of nutrient-based and exchange group methods. Kendall, PA., Jansen, GR.[2015]

A study involving 43 nonketosis-prone diabetic patients showed that a simplified 1-hour nutritional counseling program significantly improved their nutritional knowledge.

Following the counseling, patients with previously inadequate diabetes control also demonstrated significant improvements in their diabetes management, highlighting the effectiveness of targeted nutritional education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of nutritional counseling on the blood glucose and nutritional knowledge of diabetic subjects. Chandalia, HB., Bagrodia, J.[2019]

Strong evidence indicates that the total amount of carbohydrates consumed is more crucial for managing diabetes than the specific type of carbohydrate, highlighting the importance of portion control and meal planning.

Nutrition therapy is effective in achieving treatment goals for blood sugar, lipids, and blood pressure in individuals with type 2 diabetes, and ongoing monitoring is essential to evaluate the effectiveness of lifestyle changes and medication adjustments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prioritizing diabetes nutrition recommendations based on evidence. Franz, MJ.[2015]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9839527/

Medically Tailored Meals for Food Insecurity and Type 2 ... Results from FAME-D will help inform clinical management of food insecurity when it co-occurs with T2DM. Further, results may be useful as healthcare payors are ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39672984/

Impact of Medically Tailored Meals on Clinical Outcomes ... Food insecurity decreased significantly from baseline to 3 months in the intervention (53 to 17%) compared to control (48 to 44%; p < 0.05), ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714422003652

Protocol for the Food as Medicine for Diabetes (FAME-D) trial The primary outcome is HbA1c at 6 months. Secondary outcomes include HbA1c at 12 months to assess whether the intervention effect (if any) is sustained, along ...

4. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.01307

Estimated Impact Of Medically Tailored Meals On ... This study investigated the one-year and five-year effects of implementing MTMs in US states on hospitalizations, health care expenditures, and net costs.

5. bmcnutr.biomedcentral.com bmcnutr.biomedcentral.com/articles/10.1186/s40795-024-00955-6

Health outcomes reported by healthcare providers and clients ... We found evidence that participation in MANNA's MTM program was associated with favorable health outcomes for clients with serious illness and nutritional risk.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12120087/

Impact of Medically Tailored Meals on Clinical Outcomes ... The control group received usual care. Outcomes were change from baseline to 6 months in A1c (primary), body mass index (BMI), blood pressure, ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT04828785

NCT04828785 | Food As MedicinE for Diabetes This study is an explanatory-focused randomized trial to assess a community-based medically tailored meals intervention (n=200). It will be conducted among ...