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| ID | Type | Description | Link |
|---|---|---|---|
| 2268160-1 | Other Grant/Funding Number | MaineHealth |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merelise Ametti, PhD, MPH | MaineHealth | Principal Investigator |
| Lauren Ciszak, MD | MaineHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MaineHealth | Portland | Maine | 04102 | United States |
For patient protection IPD will not be shared.
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|
| 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 |
| 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 |
| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D010549 | Personal Satisfaction |
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