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Feed the household; Dedicated driver for Healthy Eating (FAME-F Trial)

N/A
Recruiting
Led By Seth A Berkowitz, MD MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

FAME-F Trial Summary

This trial aims to determine the best way to deliver medically tailored meals to people, depending on their individual or household needs. #foodsecurity

Who is the study for?
This trial is for individuals who can control their diet, won't move away soon, and can consent to participate in English or Spanish. It's not for those without a stable place to live and store meals, no phone access, or major psychiatric conditions that hinder participation.Check my eligibility
What is being tested?
The study is testing whether medically tailored meals should be given to just one person or the whole family and how they should be delivered—by a dedicated driver or through commercial shipping—to guide future food-as-medicine studies.See study design
What are the potential side effects?
Since this trial involves healthy eating interventions rather than medications, traditional side effects are not applicable. However, changes in diet may affect digestion and energy levels.

FAME-F Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
De Jong Gierveld Total Loneliness Score
Healthy Eating Index Total Score
Secondary outcome measures
De Jong Gierveld Emotional Loneliness Score
De Jong Gierveld Social Loneliness Score
Depressive Symptoms
+5 more

FAME-F Trial Design

4Treatment groups
Active Control
Group I: Feed the household; Dedicated driverActive Control2 Interventions
Medically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household; Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings
Group II: Feed the individual; Dedicated driverActive Control2 Interventions
Medically tailored meals will be provided for the enrolled individual; Medically tailored meals will be delivered each week by a driver who is an employee of Community Servings
Group III: Feed the individual; Commercial shipperActive Control2 Interventions
Medically tailored meals will be provided for the enrolled individual; Meals will be delivered by a commercial shipping organization
Group IV: Feed the household; Commercial shipperActive Control2 Interventions
Medically tailored meals will be provided for the enrolled individual, with additional meals provided as needed for others living the same household; Meals will be delivered by a commercial shipping organization

Find a Location

Who is running the clinical trial?

Community ServingsUNKNOWN
3 Previous Clinical Trials
406 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,942 Total Patients Enrolled
American Heart AssociationOTHER
326 Previous Clinical Trials
4,933,526 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies for participation in this experiment?

"Clinicaltrials.gov indicates that this clinical trial is not presently enrolling participants, as the last update was made on November 29th of 2023. Fortunately, there are more than one hundred other studies actively seeking patients at this time."

Answered by AI

What are the objectives of this medical investigation?

"The primary evaluation metric of this 12-week trial is the De Jong Gierveld Total Loneliness Score. Secondary measures include Healthy Eating Index Subscores, Dietary Screener Questionnaire Scores, and Household Food Security Survey Module scores; each being reflective of various facets of nutritional wellbeing."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Food as Medicine for Families
2024. "Food as Medicine for Families". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06160973.
All > High Point > Greensboro
~67 spots leftby Jul 2025
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