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Clinical Trial NCT07488767 for Prediabetes, Diabetes Mellitus, Food Insecurity is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Food Sequencing in Food Insecurity 70 Dietary
Clinical Trial NCT07488767 is an interventional study for Prediabetes, Diabetes Mellitus, Food Insecurity and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2026 and continue until the study accrues 70 participants. Led by Weill Medical College of Cornell University, this study is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 23 March 2026.
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 carboh...
Show MoreOfficial 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.
Conditions
PrediabetesDiabetes MellitusFood InsecurityOther Study IDs
- 25-10029434
NCT ID Number
Start Date (Actual)
2026-03
Last Update Posted
2026-03-23
Completion Date (Estimated)
2027-12
Enrollment (Estimated)
70
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorStandard Care Counseling In this arm, participants who are enrolled in the food insecurity produce delivery program will receive standard care counseling. | 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 |
ExperimentalFood 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. | 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). 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 |
Primary Outcome Measures
Secondary 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 |
| 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
-Nonpregnant adults ages of 18 to 75 with prediabetes or diabetes mellitus who screen positive for food insecurity and provide informed consent.
-Participants with gestational diabetes or pre-existing diabetes in pregnancy.
Weill Medical College of Cornell UniversityStudy Central Contact
Contact: Ampadi Karan, 646-962-2426, [email protected]
1 Study Locations in 1 Countries
New York
Weill Cornell Medicine-Endocrinology, New York, New York, 10021, United States
Ampadi Karan, Contact, 646-962-2426, [email protected]
Gwendolyne Jack, MD, Principal Investigator