Clinical Trials Directory

Trials / Completed

CompletedNCT06415370

Food and Friends: Healthy Meals Delivered to You

Examining the Relationship Between Home-Delivered Healthy Meals to Seniors and Social Connectedness: A Mixed Methods Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
University of North Carolina, Chapel Hill · Academic / Other
Sex
All
Age
65 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHome Delivered Healthy MealsIn-person delivery of HDHM at least one time weekly for 12 weeks.
BEHAVIORALIn-person "friendly visits""Friendly visits" last approximately 5-10 minutes and include brief "wellness check" questions such as, "How are you doing today?" "Did you try \[HDHM recipe\] yesterday- how did it taste? Any suggestions for future flavors?" "What are some of the things you plan to do in the next few days?" "Is there anything else you want to share with me?"
BEHAVIORALStudent Companion callsStudent Companions call participants at least one time weekly to provide telephone reassurance- i.e., checking on the participant's well-being. These calls may also include referrals to appropriate resources such as NCCARE 360 (statewide network that connects individuals with complex health and social needs, to community resources and service)

Timeline

Start date
2024-08-14
Primary completion
2024-11-15
Completion
2024-11-15
First posted
2024-05-16
Last updated
2025-02-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06415370. Inclusion in this directory is not an endorsement.