Giving Healthy Meal Kits and Cooking Lessons to Rural Families with Food Insecurity.

NCT ID: NCT06869993

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-31
• Study Completion Date: 2025-12-31

Brief 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.

Conditions

Food Insecurity; Food Insecurity Among Children; Social Emotional Wellness; Caregiver Stress; Caregiver Distress; Caregiver Mental Health; Family Function; Family Functioning; Nutrition; Child Mental Health

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Participants

Participants will receive 4 weeks of health meal kits delivered to their homes in addition culinary medicine education via an app. They will also participate in weekly as well as pre-and post-intervention assessments.

Group Type: EXPERIMENTAL

Meal Kit plus Mobile Culinary Medicine Education

Intervention Type: DIETARY_SUPPLEMENT

This intervention will involve four phases: (1) a baseline assessment; (2) a 7-day monitoring phase, (3) a 30-day intervention phase in which all households receive weekly meal kits delivered to their home in addition to mobile culinary medicine education; and (4) a follow-up assessment.

Interventions

Meal Kit plus Mobile Culinary Medicine Education

This intervention will involve four phases: (1) a baseline assessment; (2) a 7-day monitoring phase, (3) a 30-day intervention phase in which all households receive weekly meal kits delivered to their home in addition to mobile culinary medicine education; and (4) a follow-up assessment.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MaineHealth

OTHER

Sponsor Role: lead

Responsible Party

Lauren Ciszak

Postdoctoral Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Merelise Ametti, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Lauren Ciszak, MD

Role: PRINCIPAL_INVESTIGATOR

MaineHealth

Locations

MaineHealth

Portland, Maine, United States

Countries

United States

Central Contacts

Lauren Ciszak, MD

Role: CONTACT

foodandfamilies@mainehealth.org

866-804-2499

Merelise Ametti, PhD, MPH

Role: CONTACT

foodandfamilies@mainehealth.org

207-396-8100

Facility Contacts

Lauren Ciszak, MD

Role: primary

foodandfamilies@mainehealth.org

866-804-2499

Other Identifiers

2268160-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Food and Families

Identifier Type: -

Identifier Source: org_study_id