Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
66 participants
INTERVENTIONAL
2024-08-14
2024-11-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Food as Medicine for Families
NCT06160973
Sequential Multiple Assignment Randomized Trial to Reduce Food Insecurity
NCT07031739
Time Restricted Eating for Metabolic and Psychological Optimization
NCT05997316
Food Insecurity, Social Determinants of Health
NCT06784310
Nutrition Outreach and Understanding: Research In Serving Hearts Through Healthy Eating And Tailored Support
NCT06460272
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
HDHM and Social Interaction (Intervention)
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.
Home Delivered Healthy Meals
In-person delivery of HDHM at least one time weekly for 12 weeks.
In-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?"
Student Companion calls
Student 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)
HDHM Only (Control)
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.
Home Delivered Healthy Meals
In-person delivery of HDHM at least one time weekly for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Home Delivered Healthy Meals
In-person delivery of HDHM at least one time weekly for 12 weeks.
In-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?"
Student Companion calls
Student 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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Presence of illness or allergies that would preclude consuming HDHM
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Humana Foundation
UNKNOWN
University of North Carolina, Chapel Hill
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Lindsey Haynes-Maslow, PhD, MHA
Role: PRINCIPAL_INVESTIGATOR
University of North Carolina, Chapel Hill
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
24-0190
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.