Lowering the Impact of Food Insecurity in African American Adults With Type 2 Diabetes Mellitus (LIFT-DM)

Summary

The objective of this protocol is to answer the questions: 1) Within food supplementation options, are mailed stock boxes superior to food vouchers in terms of achieving glycemic control? 2) Is the combination of mailed stock boxes and food vouchers superior to either food supplementation option alone? 3) Does providing diabetes education in combination with food supplementation lead to improved clinical outcomes compared to education alone? To address this gap in the literature, we propose a randomized controlled trial to test the separate and combined efficacy of monthly food vouchers to farmers market and monthly mailed food stock boxes layered upon diabetes education in improving glycemic control in low income, food insecure, AAs with Type 2 Diabetes (T2DM) using a 2x2 factorial design.

Conditions

• Type 2 Diabetes

Interventions

BEHAVIORAL

Diabetes Education Plus Monthly Food Vouchers

Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home.

BEHAVIORAL

Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes

Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home.

BEHAVIORAL

Diabetes Education Only

Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.

BEHAVIORAL

Diabetes Education Plus Monthly Stock Boxes

Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home.

Sponsors & Collaborators

• State University of New York at Buffalo

  lead OTHER

Principal Investigators

• Leonard E Egede, MD · State University of New York at Buffalo

• Rebekah J Walker, PhD · State University of New York at Buffalo

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Model

FACTORIAL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-15

Primary Completion

2026-06-30

Completion

2027-06-30

Countries

• United States

Study Locations