Food Sequencing in Food Insecurity

N/ANot Yet RecruitingNCT07488767

Weill Medical College of Cornell University70 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prediabetes Diabetes Mellitus Food Insecurity

Interventions

Food Order/Meal SequencingBEHAVIORAL

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 CounselingBEHAVIORAL

Standard of care counseling is standard dietary counseling based on the 10 tips for a healthy lifestyle created by choosemyplate.gov

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Weill Cornell Medicine-Endocrinology

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, Week 24

Secondary Outcomes

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.

Time frame: 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.