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NCT06784310Completed

Food Insecurity, Social Determinants of Health

Feeding the Family: Nutrition Security Intervention to Improve Physical and Mental Health Among Low-resource Families

Source: ClinicalTrials.gov · Last updated 16 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
56 (actual)
First submitted
14 Jan 2025
Start date
1 Apr 2025
Primary completion date
5 Mar 2026
Lead sponsor
Alison Gustafson
NCT number
NCT06784310

What you commit to

  • Study type: Interventional
  • Participants enrolled: 56
  • From 1 Apr 2025 to the primary completion date, 5 Mar 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Considering bariatric surgery in the next year or prior bariatric surgery
  • Known drug or alcohol misuse in the past 2 years
  • Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar.

Other illness

  • Participant in diabetes, nutrition, or weight research intervention in last 12 months
  • Known psychosis or major psychiatric illness that prevents participation with study activities

Lab values

  • Advanced kidney disease (estimated creatinine clearance \< 30 mL/min)

Age

  • History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured \> 5 years ago or in remission

Other

  • 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

Who the study is looking for

  • 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.

Age in the registry: 6 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UofL Health
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.