Food Insecurity, Social Determinants of Health

NCT06784310 | Completed

• 1 other identifier: 96706
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

Food is Medicine for the whole will test an intervention which provides medically tailored meals, or grocery voucher cards, or a combination of these food and nutrition resources to a caregiver and children living in the household. The study will examine how providing healthy tailored food and nutrition services can improve health outcomes, such as blood pressure and cholesterol levels.

Conditions

Food Insecurity; Type 2 Diabetes Mellitus (T2DM); Hypertension

Keywords

Food as medicine

Outcome Measures

Primary Outcomes (14)

• Change in body mass index (BMI) percentile - child

  BMI percentile is automatically calculated in the Electronic Health Record (EHR) from height and weight using age- and gender-specific CDC growth charts

  Baseline, post intervention (week 12), and month 6

• Change in body mass index percentile - adult

  BMI percentile is automatically calculated in the Electronic Health Record from height and weight

  Baseline, post intervention (week 12), and month 6

• Change in systolic blood pressure - child

  blood pressure measurements will be taken from the electronic health record

  Baseline, post intervention (week 12), and month 6

• Change in diastolic blood pressure - child

  blood pressure measurements will be taken from the electronic health record

  Baseline, post intervention (week 12), and month 6

• Change in systolic blood pressure - adult

  blood pressure measurements will be taken from the electronic health record

  Baseline, post intervention (week 12), and month 6

• Change in diastolic blood pressure - adult

  blood pressure measurements will be taken from the electronic health record

  Baseline, post intervention (week 12), and month 6

• Change in Hemoglobin A1c - child

  A1c measures are collected at the clinic or affiliated lab and entered into the patient's EHR

  Baseline, post intervention (week 12), and month 6

• Change in Hemoglobin A1c - adult

  A1c measures are collected at the clinic or affiliated lab and entered into the patient's EHR

  Baseline, post intervention (week 12), and month 6

• Change in total cholesterol - child

  data will be pulled from the EHR

  Baseline, post intervention (week 12), and month 6

• Change in total cholesterol - adult

  data will be pulled from the EHR

  Baseline, post intervention (week 12), and month 6

• Change in high-density lipoprotein (HDL) - child

  data will be pulled from the EHR

  Baseline, post intervention (week 12), and month 6

• Change in high-density lipoprotein (HDL) - adult

  data will be pulled from the EHR

  Baseline, post intervention (week 12), and month 6

• Change in low-density lipoprotein (LDL) - child

  data will be pulled from the EHR

  Baseline, post intervention (week 12), and month 6

• Change in low-density lipoprotein (LDL) - adult

  data will be pulled from the EHR

  Baseline, post intervention (week 12), and month 6

Secondary Outcomes (4)

• Change in Dietary Intake

  Baseline, post intervention (week 12), and month 6

• Change in Family Stress

  Baseline, post intervention (week 12), and month 6

• Change in Nutrition Security

  Baseline, post intervention (week 12), and month 6

• Change in Food Security

  Baseline, post intervention (week 12), and month 6

Study Arms (4)

MTM (medically tailored meals)

ACTIVE COMPARATOR

Fully prepared meals are delivered on a weekly basis, and tailored to specific health needs

Behavioral: Medically Tailored Meals; Behavioral: Nutritional Counseling

GP (grocery prescription)

ACTIVE COMPARATOR

cards are issued to each participant per month to be spent on eligible healthy food items

Behavioral: Grocery Prescription; Behavioral: Nutritional Counseling

MTM + GP (medically tailored meals and grocery prescription)

ACTIVE COMPARATOR

delivered weekly MTM meals and the GP monthly grocery funds

Behavioral: Medically Tailored Meals and Grocery Prescription; Behavioral: Nutritional Counseling

Nutrition Counseling

PLACEBO COMPARATOR

30 minutes per week of nutrition counseling and assistance. This group will receive the Grocery Prescription package after the last set of study measures are completed

Behavioral: Nutritional Counseling

Interventions

Medically Tailored Meals BEHAVIORAL

Dare to Care will provide meals each week for 12 weeks tailored for comorbidities. Meals will be provided to both the adult and the child(ren). Meals have been developed with a Registered Dietitian and have been approved through Food Is Medicine Coalition (FMIC). Meals are delivered via Door Dash each week.

MTM (medically tailored meals)

Grocery Prescription BEHAVIORAL

Instacart Fresh Funds (for those that need delivery) or Kroger Grocery Rx cards will be issued to each participant per month to be spent on eligible healthy food items (lean protein, lean dairy, fruits, vegetables, eggs, and nuts). For each participating child in the household, they will receive additional funds/per child loaded on their grocery Rx card

GP (grocery prescription)

Medically Tailored Meals and Grocery Prescription BEHAVIORAL

will receive both tailored MTM meals per week for adult and child(ren) and the GP monthly grocery funds

MTM + GP (medically tailored meals and grocery prescription)

Nutritional Counseling BEHAVIORAL

30 minutes per week of nutrition counseling and assistance.

GP (grocery prescription); MTM (medically tailored meals); MTM + GP (medically tailored meals and grocery prescription); Nutrition Counseling

Eligibility Criteria

• Age: 6 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Have at least one child ages 6-17, inclusive, living in the household with the adult at least 50% of the time
• Diagnosis of stage 3 or 4 Hypertension in last 12 months, or diagnosis of T2DM in the last 12 months
• 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
• Considering bariatric surgery in the next year or prior bariatric surgery
• Lack of safe, stable residence and ability to store meals
• Lack of telephone which can receive text messages
• Pregnancy/breastfeeding or intended pregnancy in the next year
• History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured \> 5 years ago or in remission
• Advanced kidney disease (estimated creatinine clearance \< 30 mL/min)
• Known drug or alcohol misuse in the past 2 years
• Known psychosis or major psychiatric illness that prevents participation with study activities
• Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar.

Sponsors & Collaborators

• Alison Gustafson: lead

Study Sites (1)

UofL Health

Louisville, Kentucky, 40211, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Alison Gustafson, PhD, MPH, RD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: A randomized trial with a 2x2 design and a delayed control comparison group.

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 20, 2025
• Study Start: April 1, 2025
• Primary Completion: March 5, 2026
• Study Completion: March 5, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)