NCT06033664

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

6 months

First QC Date

September 5, 2023

Last Update Submit

May 9, 2024

Conditions

Type 2 Diabetes MellitusHypertension

Keywords

Food InsecurityFood as MedicineMedicaid Adults

Outcome Measures

Primary Outcomes (1)

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

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

    baseline and post intervention, approximately 12 weeks

Secondary Outcomes (2)

  • Change in blood pressure

    baseline and post intervention, approximately 12 weeks

  • Change in food insecurity

    baseline and post intervention, approximately 12 weeks

Study Arms (1)

Grocery Prescription Program

EXPERIMENTAL

Participants will receive the Fresh Funds through Instacart

Behavioral: Fresh Funds

Interventions

Fresh FundsBEHAVIORAL

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.

Also known as: Grocery Prescription Program; Food As Medicine
Grocery Prescription Program

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (1)

  • Mayfield C, Lauckner C, Bush J, Cosson E, Batey L, Gustafson A. Development of a statewide network hub for screening, referral, and enrollment into food as medicine programs across Kentucky. Front Public Health. 2025 Jan 7;12:1502858. doi: 10.3389/fpubh.2024.1502858. eCollection 2024.

    PMID: 39845669DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypertension

Interventions

FoodDosage Forms

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and BeveragesPharmaceutical PreparationsTechnology, PharmaceuticalInvestigative Techniques

Study Officials

  • Alison Gustafson, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

November 6, 2023

Primary Completion

May 8, 2024

Study Completion

May 8, 2024

Last Updated

May 10, 2024

Record last verified: 2024-05

Locations

US(1)