Nutrition Intervention for Diabetes
(CHEFS-DM Trial)
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.12345Why 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.12467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive medically tailored food support and nutrition education for diabetes management
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extension
Intervention arm participants receive standard POH services to assess sustained health benefits
What Are the Treatments Tested in This Trial?
Interventions
- Food support
- Nutritional Counseling and education
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
Project Open Hand
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Project Open Hand
Collaborator