Food Sequencing in Food Insecurity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Food Order/Meal Sequencing, Standard of Care Counseling.
- Who it may be relevant to
- Registry conditions: Prediabetes, Diabetes Mellitus, Food Insecurity. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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.
Overview
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.
Interventions
- Behavioral 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). - Behavioral 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
- 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]
Secondary outcome measures (9)
- 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]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Weill Cornell Medicine-Endocrinology — New York
Identifiers
NCT: NCT07488767 · 25-10029434