PrediabetesNCT07488767
Food Sequencing in Food Insecurity
A study testing Food Order/Meal Sequencing in people with Prediabetes and Diabetes Mellitus, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Prediabetes, Diabetes Mellitus, Food Insecurity
- What is being tested?
- Food Order/Meal Sequencing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Nonpregnant adults ages of 18 to 75 with prediabetes or diabetes mellitus who screen positive for food insecurity and provide informed consent.
Who cannot join
- -Participants with gestational diabetes or pre-existing diabetes in pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Weill Cornell Medicine-Endocrinology
New York, New York, 10021
About this study
Official 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.
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
- Being tested
- Food Order/Meal Sequencing, Standard of Care Counseling
- Medical subject headings
- Prediabetic State, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Food Order/Meal SequencingBehavioural
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 CounselingBehavioural
Standard of care counseling is standard dietary counseling based on the 10 tips for a healthy lifestyle created by choosemyplate.gov
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Counseling | Active comparator | In this arm, participants who are enrolled in the food insecurity produce delivery program will receive standard care counseling. Receives: 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. Receives: Behavioral: Food Order/Meal Sequencing; Behavioral: Standard of Care Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 24
Secondary outcomes (9)
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.
Measured: 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.
Measured: Baseline and Week 24.
Change in HbA1c
HbA1c is measured based on the DCCT/NGSP standard.
Measured: Baseline and Week 24.
Change in body weight
Body weight is measured in kilograms.
Measured: 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).
Measured: Baseline and Week 24.
Change in Total Cholesterol
Cholesterol is measured in mg/dL
Measured: Baseline and Week 24.
Change in low-density lipoprotein cholesterol (LDL)
LDL is measured in mg/dL
Measured: Baseline and Week 24
Change in high-density lipoprotein cholesterol (HDL)
HDL is measured in mg/dL
Measured: Baseline and Week 24
Change in triglycerides
Triglycerides are measured in mg/dL
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start13 May 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gwendolyne Jack, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488767
- Sponsor's protocol ID
- 25-10029434
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2026
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07488767
- Acronym / sponsor ID
- 25-10029434
- Conditions
- Prediabetes, Diabetes Mellitus, Food Insecurity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 13 May 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care Counseling | Active comparator | Behavioral: Standard of Care CounselingIn this arm, participants who are enrolled in the food insecurity produce delivery program will receive standard care counseling. |
| Food Order/Meal Sequencing | Experimental | Behavioral: Food Order/Meal Sequencing, Behavioral: Standard of Care CounselingIn this arm, participants who are enrolled in the food insecurity produce delivery program will receive food order/meal sequencing counseling alongside standard care counseling. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Nonpregnant adults ages of 18 to 75 with prediabetes or diabetes mellitus who screen positive for food insecurity and provide informed consent.
Key exclusion criteria (1 listed)
- -Participants with gestational diabetes or pre-existing diabetes in pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Food Order/Meal SequencingFood 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). | Behavioural | Food Order/Meal Sequencing |
| Standard of Care CounselingStandard of care counseling is standard dietary counseling based on the 10 tips for a healthy lifestyle created by choosemyplate.gov | Behavioural | Food Order/Meal Sequencing, Standard Care Counseling |
Primary outcome
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.
9 secondary outcomes
Change in Dietary Quality Assessed by Healthy Eating Index (HEI)
Time frame: Baseline and Week 24
Change in Dietary Quality Assessed by Alternate Health Eating Index (AHEI)
Time frame: Baseline and Week 24.
Change in HbA1c
Time frame: Baseline and Week 24.
Change in body weight
Time frame: Baseline and Week 24.
Change in FIB4 score
Time frame: Baseline and Week 24.
Change in Total Cholesterol
Time frame: Baseline and Week 24.
Change in low-density lipoprotein cholesterol (LDL)
Time frame: Baseline and Week 24
Change in high-density lipoprotein cholesterol (HDL)
Time frame: Baseline and Week 24
Change in triglycerides
Time frame: Baseline and Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Prediabetes
Not yet recruiting
Different Aerobic-to-Resistance Training Ratios in Adults Aged 50 Years and Older With Prediabetes
Prediabetes
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Recruiting
Hypothalamic GLP-1 Response in Healthy Weight and Obesity
Obesity, Normal Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gwendolyne Jack, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Food Order/Meal Sequencing in people with Prediabetes and Diabetes Mellitus, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.