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

Food and Families: A Pilot Study of the Acceptability, Feasibility, and Mental Health Effects of a Meal Kit Intervention in Rural, Low-Income Families

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.

Study Overview

• Status: Completed
• Conditions: Food Insecurity; Family Functioning; Nutrition; Family Function; Caregiver Stress; Food Insecurity Among Children; Child Mental Health; Caregiver Distress; Social Emotional Wellness; Caregiver Mental Health
• Intervention / Treatment: Dietary supplement: Meal Kit plus Mobile Culinary Medicine Education

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maine
    • Portland, Maine, United States, 04102
      • MaineHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
USDA Household Food Security Survey	An 18-item questionnaire designed to assess a household's level of food insecurity during the past year, including questions related to both worry and insufficiency in relation to both adults and children living in the household	Baseline and 5 weeks
Rapid Prime Diet Quality Screener	A 13-item diet screener that assesses the frequency with which various categories of food were consumed over the past month (e.g., processed meats, vegetables, soft drinks).	Baseline and 5 weeks
Confusion, Hubbub, and Order Scale	A 15-item, caregiver-report questionnaire that assesses the level of environmental confusion in the home	Baseline and 5 weeks
24-Hour Food Recall	A structured assessment intended to capture detailed information about all foods, beverages, and dietary supplements consumed by the participant in the past 24 hours. The assessment queries about the time of day, portion size, and preparation methods of each food item.	Baseline and 5 weeks
Cooking and Food Provisioning Action Scale	A 28-question validated questionnaire assessing food agency in three separate categories (self-efficacy, structure, and attitude).	Baseline and 5 weeks
Parenting Stress Index - Short Form	A 36-item caregiver report assesses three domains of stress (parental distress, dysfunctional parent-child interactions, and difficult child).	Baseline and 5 weeks
Perceived Stress Scale	A 10-item, self-report measure that assesses the degree to which different situations are appraised as stressful, unpredictable, and uncontrollable.	Baseline and 5 weeks
Alabama Parenting Questionnaire - Short Form	A 9-item, caregiver-report measure of parenting practices that assesses domains of positive parenting, poor monitoring/supervision, and inconsistent discipline	Baseline and 5 weeks
Family Environment Scale - Fourth Edition	A self-report assessment designed to assess different aspects of family functioning via 90 true or false questions. In order to reduce participant burden, only items from the Cohesion, Conflict, Organization and Control subscale will be administered.	Baseline and 5 weeks
Child Behavior Checklist	The Child Behavior Checklist (CBCL) is a caregiver-report measure that consist of 120 problem items rated on a three-point scale (0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true) that yield empirically derived subscales related to different psychological symptoms and competence in several areas of functioning. Subscales are consistent across age, gender, informant, and culture and have test-retest reliabilities between 0.74 and 0.95 and Cronbach alphas between 0.79 and 0.97. The Brief Problem Monitor is a 19-item caregiver-report measure with parallel items and scales to the CBCL designed for assessing change over time.	Baseline and 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adult Self-Report	A self-report inventory on which caregivers rated the extent to which they have experienced 126 psychological problems during the past six months on a three-point scale 1 = somewhat or sometimes true, 2 = very true or often true). Items form empirically validated subscales that are normed by age, gender, and culture.	Baseline and 5 weeks
PROMIS Fatigue Profile	16-item, self-report measure that assesses fatigue intensity and its effects on social functioning, cognition, and motivation.	Baseline and 5 weeks
Positive and Negative Affect Schedule	A 20-item self-report measure that assesses the extent to which participants have various moods during a specified timeframe (i.e., 30 days) which yields independent positive and negative affect subscales.	Baseline and 5 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Survey	A 14-item questionnaire designed specifically for the current study was used to obtain basic information about the caregiver (e.g., age, gender identity, race, ethnicity, occupation, and level of education) as well as the composition and economic circumstances of the household.	Baseline

Collaborators and Investigators

• Sponsor: MaineHealth
• Investigators: Principal Investigator: Merelise Ametti, PhD, MPH, MaineHealth; Principal Investigator: Lauren Ciszak, MD, MaineHealth

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2025
• Primary Completion (Actual): July 8, 2025
• Study Completion (Actual): July 31, 2025

Study Registration Dates

• First Submitted: March 2, 2025
• First Submitted That Met QC Criteria: March 5, 2025
• First Posted (Actual): March 11, 2025

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; family; Caregiver Stress; Nutrition; Child Mental Health; Food Insecurity; Nutrition Security; Family Functioning; Healthy Food; Food is Medicine; Family Stress; Child stress; Childhood Food Insecurity; Child Caregiver; Nutrition Insecurity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Behavior; Personal Satisfaction; Caregiver Burden; Psychological Well-Being
• Other Study ID Numbers: Food and Families; 2268160-1 (Other Grant/Funding Number: MaineHealth)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: For patient protection IPD will not be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No