An interventional study of Meal Kit plus Mobile Culinary Medicine Education in Food Insecurity, Food Insecurity Among Children and Social Emotional Wellness, sponsored by MaineHealth. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-19.
Sponsored by MaineHealth · Not applicable, Interventional, and Supportive care
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:
Participants will:
500 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.
This study's enrollment of 40 is below the median of 71 across 402 interventional studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →MaineHealth is the lead sponsor of 36 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
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.
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
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 5 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline and 5 weeks
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.
Time frame: Baseline
Plan to share: No — For patient protection IPD will not be shared.
No publications or documents are linked to this record.
Ran from Apr 2025 to primary completion in Jul 2025, 2 months.
Of 282 non-industry interventional studies with no phase under Caregiver Burden, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 31. This study's 2 months is below that.
Counting every sponsor, half of 291 studies reached it within 16 months; a quarter within 7 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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