Clinical trial NCT06869993: Giving Healthy Meal Kits and Cooking Lessons to Rural Families with Food Insecurity.
Official title: Food and Families: a Pilot Study of the Acceptability, Feasibility, and Mental Health Effects of a Meal Kit Intervention in Rural, Low-Income Families
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Keywords: Food is Medicine
Family Stress
Child stress
Food Insecurity
Childhood Food Insecurity
Child Mental Health
Nutrition
family
Family Functioning
Mental Health
Caregiver Stress
Child Caregiver
Healthy Food
Nutrition Security
Nutrition Insecurity
Lead sponsor: MaineHealth
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: USDA Household Food Security Survey
timeFrame: Baseline and 5 weeks
measure: Rapid Prime Diet Quality Screener
timeFrame: Baseline and 5 weeks
measure: Confusion, Hubbub, and Order Scale
timeFrame: Baseline and 5 weeks
measure: 24-Hour Food Recall
timeFrame: Baseline and 5 weeks
measure: Cooking and Food Provisioning Action Scale
timeFrame: Baseline and 5 weeks
measure: Parenting Stress Index - Short Form
timeFrame: Baseline and 5 weeks
measure: Perceived Stress Scale
timeFrame: Baseline and 5 weeks
measure: Alabama Parenting Questionnaire - Short Form
timeFrame: Baseline and 5 weeks
measure: Family Environment Scale - Fourth Edition
timeFrame: Baseline and 5 weeks
measure: Child Behavior Checklist
timeFrame: Baseline and 5 weeks
Secondary outcomes:
measure: Adult Self-Report
timeFrame: Baseline and 5 weeks
measure: PROMIS Fatigue Profile
timeFrame: Baseline and 5 weeks
measure: Positive and Negative Affect Schedule
timeFrame: Baseline and 5 weeks
Other outcomes:
measure: Demographic Survey
timeFrame: Baseline
Locations:
city: Portland
country: United States
facility: MaineHealth
state: Maine
Study officials:
affiliation: MaineHealth
name: Merelise Ametti, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: MaineHealth
name: Lauren Ciszak, MD
role: PRINCIPAL_INVESTIGATOR
References: