Food Sequencing in Food Insecurity

NCT07488767 | Enrolling By Invitation

• 1 other identifier: 25-10029434
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prediabetes; Diabetes Mellitus; Food Insecurity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Change in Dietary Quality Assessed by Healthy Eating Index (HEI)

  Baseline and Week 24

• Change in Dietary Quality Assessed by Alternate Health Eating Index (AHEI)

  Baseline and Week 24.

• Change in HbA1c

  Baseline and Week 24.

• Change in body weight

  Baseline and Week 24.

• Change in FIB4 score

  Baseline and Week 24.

Study Arms (2)

Standard Care Counseling

ACTIVE COMPARATOR

In this arm, participants who are enrolled in the food insecurity produce delivery program will receive standard care counseling.

Behavioral: Standard of Care Counseling

Food Order/Meal Sequencing

EXPERIMENTAL

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: Food Order/Meal Sequencing; Behavioral: Standard of Care Counseling

Interventions

Standard of Care Counseling BEHAVIORAL

Standard of care counseling is standard dietary counseling based on the 10 tips for a healthy lifestyle created by choosemyplate.gov

Food Order/Meal Sequencing; Standard Care Counseling

Food Order/Meal Sequencing BEHAVIORAL

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).

Food Order/Meal Sequencing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine-Endocrinology

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Prediabetic State; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gwendolyne Jack, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: May 13, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)