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

NCT06869993 | Completed

• 2 other identifiers: Food and Families2268160-1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Is receiving healthy meal kits delivered to homes feasible and acceptable to rural Maine families?
2. 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. 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.
4. 4.Recieve and prepare a dietitian-designed meal kit with 10 meals per week for 4 weeks.
5. 5.Receive free culinary medicine education via an app that they will continue to have access to after the study ends.
6. 6.Complete a 1-1.5 hour virtual visit at the beginning of and end of the study.

Conditions

Food Insecurity; Caregiver Stress; Food Insecurity Among Children; Social Emotional Wellness; 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

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (3)

• Adult Self-Report

  Baseline and 5 weeks

• PROMIS Fatigue Profile

  Baseline and 5 weeks

• Positive and Negative Affect Schedule

  Baseline and 5 weeks

Other Outcomes (1)

• Demographic Survey

  Baseline

Study Arms (1)

Participants

EXPERIMENTAL

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

Interventions

Meal Kit plus Mobile Culinary Medicine Education 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.

Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MaineHealth: lead

Study Sites (1)

MaineHealth

Portland, Maine, 04102, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Merelise Ametti, PhD, MPH

  MaineHealth

  PRINCIPAL INVESTIGATOR

• Lauren Ciszak, MD

  MaineHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral Fellow

Study Record Dates

• First Submitted: March 2, 2025
• First Posted: March 11, 2025
• Study Start: April 14, 2025
• Primary Completion: July 8, 2025
• Study Completion: July 31, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)