Food InsecurityNCT06869993
Giving Healthy Meal Kits and Cooking Lessons to Rural Families With Food Insecurity.
A study testing Meal Kit plus Mobile Culinary Medicine Education in people with Food Insecurity and Food Insecurity Among Children, run by MaineHealth at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Food Insecurity, Food Insecurity Among Children, Social Emotional Wellness
- What is being tested?
- Meal Kit plus Mobile Culinary Medicine Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2025to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- Is receiving healthy meal kits delivered to homes feasible and acceptable to rural Maine families?
- 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?
- 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.
Read more
Participants will:
- Recieve and prepare a dietitian-designed meal kit with 10 meals per week for 4 weeks.
- Receive free culinary medicine education via an app that they will continue to have access to after the study ends.
- 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
- Being tested
- Meal Kit plus Mobile Culinary Medicine Education
- 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
- Medical subject headings
- Caregiver Burden, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal Kit plus Mobile Culinary Medicine EducationDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Meal Kit plus Mobile Culinary Medicine Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline and 5 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Baseline and 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start14 Apr 2025
- Primary completion8 Jul 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food InsecurityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- MaineHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Ciszak, MaineHealth
- Investigators
- Merelise Ametti, PhD, MPH, Principal investigator, MaineHealthLauren Ciszak, MD, Principal investigator, MaineHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869993
- Sponsor's protocol ID
- Food and Families
- Other IDs
- 2268160-1
- Status last verified
- Feb 2026
- First submitted
- 2 Mar 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For patient protection IPD will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06869993
- Acronym / sponsor ID
- Food and Families
- Conditions
- Food Insecurity, Food Insecurity Among Children, Social Emotional Wellness, Caregiver Stress, Caregiver Distress, Caregiver Mental Health
- Keywords
- Food is Medicine, Family Stress, Child stress, Food Insecurity, Childhood Food Insecurity, Child Mental Health, Nutrition, family
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- MaineHealthUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 8 Jul 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is receiving healthy meal kits delivered to homes feasible and acceptable to rural Maine families?
- 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?
- 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:
- Recieve and prepare a dietitian-designed meal kit with 10 meals per week for 4 weeks.
- Receive free culinary medicine education via an app that they will continue to have access to after the study ends.
- Complete a 1-1.5 hour virtual visit at the beginning of and end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Dietary Supplement: Meal Kit plus Mobile Culinary Medicine EducationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal Kit plus Mobile Culinary Medicine EducationThis 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. | Dietary supplement | Participants |
Primary outcome
USDA Household Food Security Survey
Time frame: Baseline and 5 weeks
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
Rapid Prime Diet Quality Screener
Time frame: Baseline and 5 weeks
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).
Confusion, Hubbub, and Order Scale
Time frame: Baseline and 5 weeks
A 15-item, caregiver-report questionnaire that assesses the level of environmental confusion in the home
24-Hour Food Recall
Time frame: Baseline and 5 weeks
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.
Cooking and Food Provisioning Action Scale
Time frame: Baseline and 5 weeks
A 28-question validated questionnaire assessing food agency in three separate categories (self-efficacy, structure, and attitude).
Parenting Stress Index - Short Form
Time frame: Baseline and 5 weeks
A 36-item caregiver report assesses three domains of stress (parental distress, dysfunctional parent-child interactions, and difficult child).
Perceived Stress Scale
Time frame: Baseline and 5 weeks
A 10-item, self-report measure that assesses the degree to which different situations are appraised as stressful, unpredictable, and uncontrollable.
Alabama Parenting Questionnaire - Short Form
Time frame: Baseline and 5 weeks
A 9-item, caregiver-report measure of parenting practices that assesses domains of positive parenting, poor monitoring/supervision, and inconsistent discipline
Family Environment Scale - Fourth Edition
Time frame: Baseline and 5 weeks
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.
Child Behavior Checklist
Time frame: Baseline and 5 weeks
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.
3 secondary outcomes
Adult Self-Report
Time frame: Baseline and 5 weeks
PROMIS Fatigue Profile
Time frame: Baseline and 5 weeks
Positive and Negative Affect Schedule
Time frame: Baseline and 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No. For patient protection IPD will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merelise Ametti, PhD, MPH principal investigator
MaineHealth
Lauren Ciszak, MD principal investigator
MaineHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal Kit plus Mobile Culinary Medicine Education in people with Food Insecurity and Food Insecurity Among Children, run by MaineHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
USDA Household Food Security Survey (time frame: Baseline and 5 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.