Clinical trial NCT06415370: Food and Friends: Healthy Meals Delivered to You
Official title: Examining the Relationship Between Home-Delivered Healthy Meals to Seniors and Social Connectedness: A Mixed Methods Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Issue
Food Insecurity
Keywords: Food Insecurity
Mental Health
Seniors
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Humana Foundation
First posted: 2024-05-16
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Adult Food Security Score
timeFrame: Baseline up to week 12
measure: Median Change of Adult Food Security Score
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Fruit Eaten Per Day
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Fruit Eaten Per Day
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Vegetables Eaten Per Day
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Vegetables Eaten Per Day
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Water Consumed Per Day
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Water Consumed Per Day
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Soda Consumed Per Day
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Soda Consumed Per Day
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Usage of 1% Milk, Skim Milk, and/or Low-fat Yogurt Per Day
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Usage of 1% Milk, Skim Milk, and/or Low-fat Yogurt Per Day
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Fruit Per Day
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Fruit Per Day
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Vegetable Per Day
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Consumption of Greater Than 1 Kind of Vegetable Per Day (Baseline to Week 6)
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Healthy Food Option Consideration
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Healthy Food Option Consideration
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Usage of "Nutrition Facts" Label
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Usage of "Nutrition Facts" Label
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Consideration of Food Label (Salt/Sodium)
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Consideration of Food Label (Salt/Sodium)
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Consideration of Food Label (Sugar)
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Consideration of Food Label (Sugar)
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Consideration of Food Label (Fat)
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Consideration of Food Label (Fat)
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Whole Grain Consumption
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Whole Grain Consumption
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Meal Preparation
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Meal Preparation
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Strength Training
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Strength Training
timeFrame: Baseline up to week 12
measure: Mean Change in Food Frequency Assessment- Physical Activity
timeFrame: Baseline up to week 12
measure: Median Change in Food Frequency Assessment- Physical Activity
timeFrame: Baseline up to week 12
measure: Mean Change of PRAPARE Score
timeFrame: Baseline up to week 12
measure: Median Change of PRAPARE Score
timeFrame: Baseline up to week 12
measure: Mean Change in Patient Health Questionaire-8
timeFrame: Baseline up to week 12
measure: Median Change in Patient Health Questionaire-8
timeFrame: Baseline up to week 12
measure: Mean Change in sum of University of California- Los Angeles Loneliness Scale Short form
timeFrame: Baseline up to week 12
measure: Median Change in sum of University of California- Los Angeles Loneliness Scale Short form
timeFrame: Baseline up to week 12
measure: Number of successful HDHM Deliveries made to participants in control group
timeFrame: Baseline up to week 12
measure: Number of successful HDHM Deliveries and Social Interactions made to participants in intervention group
timeFrame: Baseline up to week 12
measure: Number of HDHM meals consumed by participants weekly
timeFrame: Baseline up to week 12
measure: Duration of Student Companion Calls
timeFrame: Baseline up to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Lindsey Haynes-Maslow, PhD, MHA
role: PRINCIPAL_INVESTIGATOR
References: