Food and Families: A Pilot Study of the Acceptability, Feasibility, and Mental Health Effects of a Meal Kit Intervention in Rural, Low-Income Families
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MaineHealth
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- USDA Household Food Security Survey
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Meal Kit plus Mobile Culinary Medicine Education (Dietary Supplement)
结局指标
主要结局
USDA Household Food Security Survey
时间窗: 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
时间窗: 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
时间窗: Baseline and 5 weeks
A 15-item, caregiver-report questionnaire that assesses the level of environmental confusion in the home
24-Hour Food Recall
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- Adult Self-Report(Baseline and 5 weeks)
- PROMIS Fatigue Profile(Baseline and 5 weeks)
- Positive and Negative Affect Schedule(Baseline and 5 weeks)