CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 281 enrolled
Drug / intervention
Food support +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04959487
NCT04959487N/ACompleted
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Food is Medicine: Randomized Trial of Medically-Tailored Food Support for Diabetes Health

University of California, San Francisco·interventional·Posted Jul 13, 2021·Updated Feb 24, 2026

In Brief

A clinical study evaluating Food support and Nutritional Counseling and education for Type 2 Diabetes and Food Insecurity. Completed, enrolled 281 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes, Food Insecurity
CountriesUnited States
CollaboratorsNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Project Open Hand

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJul 13, 2021
Enrollment StartAug 23, 2021
Primary CompletionFeb 5, 2025
Study CompletionJun 12, 2025
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.0 years ago

Interventions

Food supportother

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 educationother

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.