Food Insecurity, Social Determinants of Health

Alison Gustafson

Status: Active, not recruiting

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06784310

96706

Details and patient eligibility

About

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.

Full 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).

Enrollment: 85 patients

Sex: All

Ages: 6 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 4 patient groups, including a placebo group

MTM (medically tailored meals)

Active Comparator group

Description:

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

Treatment:

Behavioral: Medically Tailored Meals

Behavioral: Nutritional Counseling

GP (grocery prescription)

Active Comparator group

Description:

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

Treatment:

Behavioral: Grocery Prescription

Behavioral: Nutritional Counseling

MTM + GP (medically tailored meals and grocery prescription)

Active Comparator group

Description:

delivered weekly MTM meals and the GP monthly grocery funds

Treatment:

Behavioral: Medically Tailored Meals and Grocery Prescription

Behavioral: Nutritional Counseling

Nutrition Counseling

Placebo Comparator group

Description:

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

Treatment:

Behavioral: Nutritional Counseling