Giving Healthy Meal Kits and Cooking Lessons to Rural Families With Food Insecurity. (NCT06869993) | Clinical Trial Compass
CompletedNot Applicable
Giving Healthy Meal Kits and Cooking Lessons to Rural Families With Food Insecurity.
United States40 participantsStarted 2025-04-14
Plain-language summary
The goal of this clinical trial is to learn if providing healthy meal kits to food insecure families can help lessen the social and emotional impacts of food insecurity on kids and their caregivers in rural Maine. The main questions it aims to answer are:
1. Is receiving healthy meal kits delivered to homes feasible and acceptable to rural Maine families?
2. Does receiving meal kits (along with an app to help learn how to cook the food) improve food insecurity and diet quality in rural Maine families?
3. Does receiving meal kits (along with an app to help learn how to cook the food) improve family function in rural Maine families? We will look at caregivers' stress, family conflict, household chaos, and child emotional-behavioral symptoms.
Participants will:
1. Recieve and prepare a dietitian-designed meal kit with 10 meals per week for 4 weeks.
2. Receive free culinary medicine education via an app that they will continue to have access to after the study ends.
3. Complete a 1-1.5 hour virtual visit at the beginning of and end of the study.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older.
* Legal caregiver for a child between the ages of 6-12 with whom they live at least 75% of the time.
* Reside in rural county in Maine as designated by the Health Resources and Services Administration.
* Endorse food insufficiency within the past month on their screening questionnaire.
* Able to speak and read in English.
* Stable address with the ability to receive packages
Exclusion Criteria:
* Inadequate access (\<5 days/week) to a kitchen with refrigeration and heating elements to prepare meals.
* Food-restrictive diet (i.e., veganism, gluten-free, dialysis-dependent, severe heart failure).
* A household member with any anaphylactic food allergy.
* No access to a smartphone with texting capabilities.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.