Food and Friends: Healthy Meals Delivered to You

University of North Carolina (UNC)

Status: Completed

Conditions: Mental Health Issue; Food Insecurity

Treatments: Behavioral: In-person "friendly visits"; Behavioral: Student Companion calls; Behavioral: Home Delivered Healthy Meals

Study type: Interventional

Funder types: Other

Identifiers

NCT06415370

24-0190

Details and patient eligibility

About

The goal of this clinical trial is to learn if home delivered healthy meals (HDHM) with or without (intervention vs. control) social interaction can impact mental health and food security in adults aged 65 and older who live alone and have trouble accessing food.

The main questions it aims to answer are:

Does HDHM with or without social interaction change the quality of participant food intake? Does HDHM with or without social interaction change the loneliness that participants may experience? Does HDHM with or without social interaction change the depression that participants may experience?

Researchers will compare a group that receives HDHM only to a group that receives HDHM and social interaction to see if there is a difference between the two groups in their experienced loneliness and depression, and the quality of food that they eat.

Participants will receive 12 weeks' worth of HDHM delivered to their home. Half of the participants will receive weekly phone calls from volunteer student "companions) Participants will also be asked to complete questionnaires over the phone at three timepoints (baseline, 6 weeks, and 12 weeks) during the study. Some participants may also be asked to give their opinions on the program via a telephone conversation.

Full description

This study is a randomized control trial (RCT) to measure the impact of a combined social interaction and culturally tailored home delivered healthy meals (HDHM) intervention on participants' mental health and food insecurity compared to those in the control group receiving HDHM alone. In addition, the study aims to test the feasibility of including structured, consistent social interactions as part of HDHM.

This study will include a sample size of 60 participants. Participants in the study will be randomized to a HDHM only group (control), or HDHM with social interactions group (intervention). All participants will receive HDHM (a frozen meal product based on the Mediterranean Diet adapted for United States Southeastern taste preferences) for 12 weeks.

The study team will collect data from participants at baseline, 6 weeks, and 12 weeks via a telephone-administered survey.

A subgroup of 10 participants (5 from the intervention, 5 from the control group) will participate in informant interviews to assess feasibility.

Enrollment: 66 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 65 and older
• Live alone
• Screen positive for food insecurity or have a medical professional concerned about their food security
• Diagnosed with at least 1 diet-related chronic illness
• Be a Medicaid/Medicare dual beneficiary
• Speak English
• Have a microwave

Exclusion criteria

• Diagnosis of dementia/Alzheimer's
• Presence of illness or allergies that would preclude consuming HDHM

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

66 participants in 2 patient groups

HDHM and Social Interaction (Intervention)

Experimental group

Description:

Home delivered healthy meals are delivered in-person, including a "friendly visit" with the participant if the participant desires. Student companions will also contact participants at least one time weekly for telephone reassurance and to provide resource referrals.

Treatment:

Behavioral: Student Companion calls

Behavioral: Home Delivered Healthy Meals

Behavioral: In-person "friendly visits"

HDHM Only (Control)

Experimental group

Description:

Home delivered healthy meals are delivered directly to the participant or dropped off at the participant's home in a cooler at their front door if they are not available. Any interaction will be limited.

Treatment:

Behavioral: Home Delivered Healthy Meals