Food Sequencing in Food Insecurity

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT07488767
Status
Not Yet Recruiting

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Conditions

  • Diabetes Mellitus
  • Food Insecurity
  • Prediabetes

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard Care Counseling
    In this arm, participants who are enrolled in the food insecurity produce delivery program will receive standard care counseling.
  • Experimental: Food 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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Weill Cornell Medicine-EndocrinologyNew YorkNew York10021
Ampadi Karan
[email protected]
646-962-2426
Gwendolyne Jack, MD (PRINCIPAL_INVESTIGATOR)

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By research site
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