Food Sequencing in Food Insecurity

Food Sequencing in Food Insecurity: The Impact of Food Order/Meal Sequence Counseling Added to Standard Care and a Produce Delivery Program in People With Diabetes/Prediabetes Who Experience Food Insecurity.

The purpose of this study is study the impact of meal sequencing when added to standard care in individuals with diabetes mellitus/prediabetes who receive produce boxes as part of a food insecurity program.

Meal sequencing is a way of eating where proteins and vegetables are consumed before carbohydrates. Eating proteins and vegetables first has shown to cause lower post meal glucose levels compared to eating carbohydrates first in a meal.

The investigators believe participants with prediabetes or diabetes mellitus experiencing food insecurity enrolled in a produce delivery program and receive meal sequencing counseling will have improvement in glucose levels and dietary quality compared to those who are enrolled in the produce delivery program and receive standard nutritional counseling.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus; Food Insecurity; Prediabetes
• Intervention / Treatment: Behavioral: Standard of Care Counseling; Behavioral: Food Order/Meal Sequencing

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ampadi Karan; Phone Number: 646-962-2426; Email: amk2028@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Weill Cornell Medicine-Endocrinology
      • Contact: Ampadi Karan; Phone Number: 646-962-2426; Email: amk2028@med.cornell.edu
      • Principal Investigator: Gwendolyne Jack, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

-Nonpregnant adults ages of 18 to 75 with prediabetes or diabetes mellitus who screen positive for food insecurity and provide informed consent.

Exclusion Criteria:

-Participants with gestational diabetes or pre-existing diabetes in pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Care Counseling; In this arm, participants who are enrolled in the food insecurity produce delivery program will receive standard care counseling.	Behavioral: Standard of Care Counseling; Standard of care counseling is standard dietary counseling based on the 10 tips for a healthy lifestyle created by choosemyplate.gov
Experimental: Food Order/Meal Sequencing; In this arm, participants who are enrolled in the food insecurity produce delivery program will receive food order/meal sequencing counseling alongside standard care counseling.	Behavioral: Standard of Care Counseling; Standard of care counseling is standard dietary counseling based on the 10 tips for a healthy lifestyle created by choosemyplate.gov; Behavioral: Food Order/Meal Sequencing; Food order/meal sequencing is a behavioral intervention where one consumes protein-rich food and non-starchy vegetables followed by carbohydrates resulting in lower postprandial glycemic excursions compared to those who consume the same foods in the reverse order (carbohydrates first).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the effect of meal sequencing on Time in Range (TIR) using continuous glucose monitoring (CGM) between baseline and week 24.	Time in range is measured as the percentage of time a participant spends within the target blood glucose range of 70-180mg/dL for participants with diabetes mellitus and 63-140 mg/dL for participants with pre-diabetes. Change in time in range between baseline and week 24 blood glucose range will be assessed.	Baseline, Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dietary Quality Assessed by Healthy Eating Index (HEI)	Diet quality will be assessed using the Healthy Eating Index (HEI) which will be computed from the Automated Self-Administered Dietary Assessment (ASA24) outputs. The HEI is a measure of diet quality that is used to evaluate how well a diet aligns with key recommendations and dietary patterns published in the Dietary Guidelines for Americans (Dietary Guidelines). The overall HEI score consists of 13 parts that reflect the different food groups and key recommendations in the Dietary Guidelines for Americans. These different parts are scored. Higher scores indicate better dietary quality. A score of 100, which is the highest score, reflects a diet that aligns with the Dietary guidelines for Americans, >80 indicates a good diet, 51-80 indicates a diet that needs improvement, <51 implies a poor diet. The lowest possible score is 0.	Baseline and Week 24
Change in Dietary Quality Assessed by Alternate Health Eating Index (AHEI)	Diet quality will be assessed using Alternate Healthy Eating Index which will be computed from the Automated Self-Administered Dietary Assessment (ASA24) outputs. Scores range from 0 to 110. Higher scores on the AHEI indicate eating patterns that reduce chronic disease risk. It evaluates 11 components and each component is scored from 0-10.	Baseline and Week 24.
Change in HbA1c	HbA1c is measured based on the DCCT/NGSP standard.	Baseline and Week 24.
Change in body weight	Body weight is measured in kilograms.	Baseline and Week 24.
Change in FIB4 score	FIB4 score is interpreted as <1.30 (low risk), 1.30-2.67 (intermediate), and 2.67 (high risk for advanced fibrosis).	Baseline and Week 24.
Change in Total Cholesterol	Cholesterol is measured in mg/dL	Baseline and Week 24.
Change in low-density lipoprotein cholesterol (LDL)	LDL is measured in mg/dL	Baseline and Week 24
Change in high-density lipoprotein cholesterol (HDL)	HDL is measured in mg/dL	Baseline and Week 24
Change in triglycerides	Triglycerides are measured in mg/dL	Baseline and Week 24

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Gwendolyne Jack, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 23, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 25-10029434

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No