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Enrolling by Invitation

NCT Number: NCT07488767

Food Sequencing in 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.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Food Insecurity Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine-Endocrinology

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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

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 frame: Baseline, 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.

Secondary outcomes

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

    Time frame: Baseline and Week 24

    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.

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

    Time frame: Baseline and Week 24.

    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.

  3. Change in HbA1c

    Time frame: Baseline and Week 24.

    HbA1c is measured based on the DCCT/NGSP standard.

  4. Change in body weight

    Time frame: Baseline and Week 24.

    Body weight is measured in kilograms.

  5. Change in FIB4 score

    Time frame: Baseline and Week 24.

    FIB4 score is interpreted as <1.30 (low risk), 1.30-2.67 (intermediate), and 2.67 (high risk for advanced fibrosis).

  6. Change in Total Cholesterol

    Time frame: Baseline and Week 24.

    Cholesterol is measured in mg/dL

  7. Change in low-density lipoprotein cholesterol (LDL)

    Time frame: Baseline and Week 24

    LDL is measured in mg/dL

  8. Change in high-density lipoprotein cholesterol (HDL)

    Time frame: Baseline and Week 24

    HDL is measured in mg/dL

  9. Change in triglycerides

    Time frame: Baseline and Week 24

    Triglycerides are measured in mg/dL

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 23, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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