Clinical trial NCT06784310: Food Insecurity, Social Determinants of Health
Official title: Feeding the Family: Nutrition Security Intervention to Improve Physical and Mental Health Among Low-resource Families
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Food Insecurity
Type 2 Diabetes Mellitus (T2DM)
Hypertension
Keywords: Food as medicine
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 280
Sex: ALL
Minimum age (years): 6
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized trial with a 2x2 design and a delayed control comparison group.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: The proposal addresses the key goals of Humana Foundation related to, "Effective and equitable interventions to increase access to healthy diets promoting physical \& mental health benefits". The interdisciplinary team comprised of clinicians, researchers in public health, nutrition, mental health, and community partners will evaluate the effectiveness of a whole family nutrition security intervention to provide evidence supporting key policies on reimbursement of health-related social needs (HRSN) as a medically covered benefit. The study team will use a user-centered approach to examine how to engage the whole family in the short-term, while creating a sustainable model for clinic and community partnerships to use in the long-term. This proposal aims to answer the question "How can a food as medicine choice model with tailored dose improve health outcomes across the family?". To answer this question, investigators are proposing a pragmatic randomized control trial (pRCT) using a 2X2 factorial design among Medicaid families, adults with children ages 5-18, with an adult diagnosed with either hypertension or Type 2 Diabetes (T2DM), child has a BMI categorized as obese or overweight, and report being food insecure. The pRCT will take place in Louisville, Kentucky with University of Louisville Health as the clinic provider, in an urban setting with a high percentage of adults reporting race/ethnicity as Black or African American. The community partners are Dare to Care Food Bank as the medically tailored meal (MTM) provider, and Kroger Health/Soda Health as the grocery prescription provider (GP).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in body mass index (BMI) percentile - child
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in body mass index percentile - adult
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in systolic blood pressure - child
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in diastolic blood pressure - child
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in systolic blood pressure - adult
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in diastolic blood pressure - adult
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in Hemoglobin A1c - child
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in Hemoglobin A1c - adult
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in total cholesterol - child
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in total cholesterol - adult
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in high-density lipoprotein (HDL) - child
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in high-density lipoprotein (HDL) - adult
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in low-density lipoprotein (LDL) - child
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in low-density lipoprotein (LDL) - adult
timeFrame: Baseline, post intervention (week 12), and month 6
Secondary outcomes:
measure: Change in Dietary Intake
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in Family Stress
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in Nutrition Security
timeFrame: Baseline, post intervention (week 12), and month 6
measure: Change in Food Security
timeFrame: Baseline, post intervention (week 12), and month 6
Other outcomes:
Locations:
city: Louisville
country: United States
facility: UofL Health
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Alison Gustafson, PhD, MPH, RD
role: PRINCIPAL_INVESTIGATOR
References: