Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415370
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-10
Brief Title:
Food and Friends Healthy Meals Delivered to You
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Examining the Relationship Between Home-Delivered Healthy Meals to Seniors and Social Connectedness A Mixed Methods Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None