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OpenTrials
Completed

NCT Number: NCT06033664

Grocery Prescription Program for Medicaid Adults With Hypertension or Type 2 Diabetes

The purpose of this study is to evaluate the effectiveness of a grocery prescription program in adults diagnosed with either Type 2 Diabetes Mellitus or Hypertension. Participants will enroll in Instacart Fresh Funds program. Once enrolled each week participants will select foods that are eligible in the Fresh Funds Program to be delivered to their home for 12 weeks. Participants will also participate in a survey at the beginning of the study and at the end of the study.

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Key information

Conditions

Type 2 Diabetes Mellitus Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypertension Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40506, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Type 2 Diabetes Mellitus, hemoglobin A1c = 7.0% and = 12.0% in last 12 months, or diagnosis of hypertension
  • Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
  • English speaking
  • No plans to move from the area for at least 1 year
  • Willing and able to accept text messages
  • Free living to the extent that participant has control over dietary intake
  • Willing and able to provide written informed consent and participate in all study activities.

Exclusion criteria

  • Participant in diabetes, nutrition, or weight research intervention in last 12 months
  • Another member of the household is already enrolled in this study
  • Considering bariatric surgery in the next year or prior bariatric surgery
  • Lack of safe, stable residence and ability to store meals

Treatment and study plan

Fresh Funds

Behavioral

Participants will enroll in Instacart Fresh Funds program. Once enrolled participants will select foods that are eligible in the Fresh Funds to be delivered to their home each week for 12 weeks.

Other names: Grocery Prescription Program; Food As Medicine

Primary outcomes

  1. Number of participants with a percentage change in Hemoglobin A1C (HbgA1C)

    Time frame: baseline and post intervention, approximately 12 weeks

    HbgA1C will be obtained baseline and post intervention by the healthcare provider from the medical chart.

Secondary outcomes

  1. Change in blood pressure

    Time frame: baseline and post intervention, approximately 12 weeks

    Both systolic and diastolic blood pressure will be obtained baseline and post intervention by the healthcare provider from the medical chart.

  2. Change in food insecurity

    Time frame: baseline and post intervention, approximately 12 weeks

    The USDA 6 item food insecurity screener will be used. The scale ranges from 0 to 6 with a higher score indicating greater food insecurity.

Sponsors and collaborators

Lead sponsor

Alison Gustafson

Other

Collaborators

  • Instacart Health
  • Kentucky Association of Health Plans

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 13, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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