ACTIVE_NOT_RECRUITING

Food Insecurity, Social Determinants of Health

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Conditions

Food InsecurityType 2 Diabetes Mellitus (T2DM)HypertensionFood as medicine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-01
Study Completion:2026-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06784310

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 64 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Have at least one child ages 6-17, inclusive, living in the household with the adult at least 50% of the time
  2. * Diagnosis of stage 3 or 4 Hypertension in last 12 months, or diagnosis of T2DM in the last 12 months
  3. * Experiencing food insecurity as indicated by 2-item Hunger Vital Sign
  4. * English speaking
  5. * No plans to move from the area for at least 1 year
  6. * Willing and able to accept text messages
  7. * Free living to the extent that participant has control over dietary intake
  8. * Willing and able to provide written informed consent and participate in all study activities.
  1. * Participant in diabetes, nutrition, or weight research intervention in last 12 months
  2. * Considering bariatric surgery in the next year or prior bariatric surgery
  3. * Lack of safe, stable residence and ability to store meals
  4. * Lack of telephone which can receive text messages
  5. * Pregnancy/breastfeeding or intended pregnancy in the next year
  6. * History of malignancy, other than non-melanoma skin cancer, unless surgically or medically cured \> 5 years ago or in remission
  7. * Advanced kidney disease (estimated creatinine clearance \< 30 mL/min)
  8. * Known drug or alcohol misuse in the past 2 years
  9. * Known psychosis or major psychiatric illness that prevents participation with study activities
  10. * Intermittent use of medications (e.g., oral or intravenous glucocorticoids) that are likely to affect blood sugar.

Contacts and Locations

Principal Investigator

Alison Gustafson, PhD, MPH, RD
PRINCIPAL_INVESTIGATOR
University of Kentucky

Study Locations (Sites)

UofL Health
Louisville, Kentucky, 40211
United States

Collaborators and Investigators

Sponsor: Alison Gustafson

  • Alison Gustafson, PhD, MPH, RD, PRINCIPAL_INVESTIGATOR, University of Kentucky

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2026-06-30

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

  • Food as medicine

Additional Relevant MeSH Terms

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