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

281 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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.

Is nutrition intervention for diabetes safe for humans?

Nutrition interventions, including personalized nutrition education and medical nutrition therapy, are generally safe for humans and can improve dietary behaviors and clinical parameters in people with diabetes. These interventions are supported by registered dietitians and focus on balanced diets, which can help manage blood sugar levels and reduce the risk of other health issues. ^{1 2 3 4 5}

How does the Nutrition Intervention for Diabetes treatment differ from other diabetes treatments?

This treatment is unique because it combines food support, nutritional counseling, and education to improve diabetes management, focusing on personalized dietary advice and education to enhance patients' understanding and control of their condition, unlike standard treatments that may primarily focus on medication. ^{5 6 7 8 9}

What data supports the effectiveness of the treatment Food support, Nutritional Counseling and education for diabetes?

Research shows that nutrition education and counseling can improve knowledge and attitudes about diet in people with diabetes, leading to better self-management and health outcomes. Studies have found that different methods of nutrition education, like diet guides, can effectively help patients plan meals and maintain improved dietary habits over time. ^{9 10 11 12 13}

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 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]

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]

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]

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]

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]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

The diabetes nutrition education study randomized controlled trial: A comparative effectiveness study of approaches to nutrition in diabetes self-management education. [2022]

2. Jamaica pubmed.ncbi.nlm.nih.gov

Nutritional Knowledge, Attitude and Practice among Patients with Type 2 Diabetes in North Central Health Authority in Trinidad and Tobago. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Diet self-management and readiness to change in underserved adults with type 2 diabetes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Outcomes monitoring of health, behavior, and quality of life after nutrition intervention in adults with type 2 diabetes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Educating patients with diabetes: comparison of nutrient-based and exchange group methods. [2015]

6. Italy pubmed.ncbi.nlm.nih.gov

Prioritizing diabetes nutrition recommendations based on evidence. [2015]

7. Korea (South) 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Diabetes Self-Management Education and Medical Nutrition Therapy: A Multisite Study Documenting the Efficacy of Registered Dietitian Nutritionist Interventions in the Management of Glycemic Control and Diabetic Dyslipidemia through Retrospective Chart Review. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Practical Strategies to Help Reduce Added Sugars Consumption to Support Glycemic and Weight Management Goals. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Diabetes: support for those at risk of malnutrition in the community. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Effect of nutritional counseling on the blood glucose and nutritional knowledge of diabetic subjects. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Nutrition interventions for intensive therapy in the Diabetes Control and Complications Trial. The DCCT Research Group. [2019]

13. Spain pubmed.ncbi.nlm.nih.gov

[Medical nutritional therapy and therapeutic patient education in diabetes]. [2011]