Food & Friends: Healthy Meals Delivered to You

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06415370
Study type	Interventional
Source	University of North Carolina, Chapel Hill
Contact	Lindsey Haynes-Maslow, PhD, MHA
Phone	910-612-3299
Email	lhaynes6@email.unc.edu
Status	Not yet recruiting
Phase	N/A
Start date	May 2024
Completion date	September 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05777044` - The Effect of Hatha Yoga on Mental Health	N/A
Recruiting	`NCT05064293` - Assisted Identification and Navigation of Early Mental Health Symptoms in Children	N/A
Not yet recruiting	`NCT05886595` - Being Young : My Mental Health
Active, not recruiting	`NCT05903638` - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility	N/A
Not yet recruiting	`NCT04030858` - The INFINITE Study: A Prospective Investigation of a Nutrient-dense Diet in Early Addiction Recovery	N/A
Recruiting	`NCT04926675` - Development of a Money Advice Intervention Within IAPT	N/A
Recruiting	`NCT06105970` - Chinese Community Sample of Hierarchical Model of Psychopathology
Recruiting	`NCT06038721` - Unified Protocol: Community Connections	N/A
Not yet recruiting	`NCT04978194` - Effects of an Intervention on University Students' Mental Health and Learning During COVID-19	N/A
Completed	`NCT05056428` - Effects of Mindfulness Training on Emotional Care Strategies	N/A
Recruiting	`NCT06144905` - Norwegian Microbiota Study in Anorexia Nervosa
Completed	`NCT06080685` - Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents	N/A
Not yet recruiting	`NCT06187701` - Co-Active Therapeutic Theatre (Co-ATT) for Dual-Diagnosis Patients	N/A
Not yet recruiting	`NCT06430853` - Psychobiological Interventions in Pregnancy	N/A
Not yet recruiting	`NCT06266936` - Smart Life Smart Living Intercontinental - Medical Students' Cohort
Not yet recruiting	`NCT06006936` - Testing an Evidence-Based Self-Help Program for Infertility-Related Distress in Women	N/A
Not yet recruiting	`NCT05979649` - An Internet-Based Intervention With Peer Support for the Mental Health of Youths	N/A
Recruiting	`NCT05492305` - Glucagon-like Peptide 1 (GLP1) Receptor Agonists and Mental Health
Not yet recruiting	`NCT05316948` - Mental Health and Sexuality in Adolescents and Young Adults
Completed	`NCT05598697` - Economic Evaluation of the MEWE Intervention	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Food and Friends: Healthy Meals Delivered to You

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms