Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-06 @ 7:11 AM
Study NCT ID:
NCT07488767
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Sequencing in Food Insecurity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-17', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the effect of meal sequencing on Time in Range (TIR) using continuous glucose monitoring (CGM) between baseline and week 24.', 'timeFrame': 'Baseline, Week 24', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in Dietary Quality Assessed by Healthy Eating Index (HEI)', 'timeFrame': 'Baseline and Week 24', 'description': 'Diet quality will be assessed using the Healthy Eating Index (HEI) which will be computed from the Automated Self-Administered Dietary Assessment (ASA24) outputs.\n\nThe 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).\n\nThe 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.'}, {'measure': 'Change in Dietary Quality Assessed by Alternate Health Eating Index (AHEI)', 'timeFrame': 'Baseline and Week 24.', 'description': 'Diet quality will be assessed using Alternate Healthy Eating Index which will be computed from the Automated Self-Administered Dietary Assessment (ASA24) outputs.\n\nScores 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.'}, {'measure': 'Change in HbA1c', 'timeFrame': 'Baseline and Week 24.', 'description': 'HbA1c is measured based on the DCCT/NGSP standard.'}, {'measure': 'Change in body weight', 'timeFrame': 'Baseline and Week 24.', 'description': 'Body weight is measured in kilograms.'}, {'measure': 'Change in FIB4 score', 'timeFrame': 'Baseline and Week 24.', 'description': 'FIB4 score is interpreted as \\<1.30 (low risk), 1.30-2.67 (intermediate), and 2.67 (high risk for advanced fibrosis).'}, {'measure': 'Change in Total Cholesterol', 'timeFrame': 'Baseline and Week 24.', 'description': 'Cholesterol is measured in mg/dL'}, {'measure': 'Change in low-density lipoprotein cholesterol (LDL)', 'timeFrame': 'Baseline and Week 24', 'description': 'LDL is measured in mg/dL'}, {'measure': 'Change in high-density lipoprotein cholesterol (HDL)', 'timeFrame': 'Baseline and Week 24', 'description': 'HDL is measured in mg/dL'}, {'measure': 'Change in triglycerides', 'timeFrame': 'Baseline and Week 24', 'description': 'Triglycerides are measured in mg/dL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prediabetes', 'Diabetes Mellitus', 'Food Insecurity']}, 'descriptionModule': {'briefSummary': '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.\n\nMeal 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Nonpregnant adults ages of 18 to 75 with prediabetes or diabetes mellitus who screen positive for food insecurity and provide informed consent.\n\nExclusion Criteria:\n\n-Participants with gestational diabetes or pre-existing diabetes in pregnancy.'}, 'identificationModule': {'nctId': 'NCT07488767', 'briefTitle': 'Food Sequencing in Food Insecurity', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '25-10029434'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Care Counseling', 'description': 'In this arm, participants who are enrolled in the food insecurity produce delivery program will receive standard care counseling.', 'interventionNames': ['Behavioral: Standard of Care Counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Food Order/Meal Sequencing', 'description': '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.', 'interventionNames': ['Behavioral: Food Order/Meal Sequencing', 'Behavioral: Standard of Care Counseling']}], 'interventions': [{'name': 'Food Order/Meal Sequencing', 'type': 'BEHAVIORAL', 'description': '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).', 'armGroupLabels': ['Food Order/Meal Sequencing']}, {'name': 'Standard of Care Counseling', 'type': 'BEHAVIORAL', 'description': 'Standard of care counseling is standard dietary counseling based on the 10 tips for a healthy lifestyle created by choosemyplate.gov', 'armGroupLabels': ['Food Order/Meal Sequencing', 'Standard Care Counseling']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Ampadi Karan', 'role': 'CONTACT', 'email': 'amk2028@med.cornell.edu', 'phone': '646-962-2426'}, {'name': 'Gwendolyne Jack, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Weill Cornell Medicine-Endocrinology', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Ampadi Karan', 'role': 'CONTACT', 'email': 'amk2028@med.cornell.edu', 'phone': '646-962-2426'}], 'overallOfficials': [{'name': 'Gwendolyne Jack, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}