Home Plate: A Trial to Improve Home Food Preparation Practices Among Parents of Toddlers
2019年4月22日 更新者：Children's Hospital of Philadelphia
Home Plate: A Randomized Controlled Trial of a Community-Engaged Intervention to Improve Home Food Preparation Practices and Health During Early Childhood
This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children.
研究概览
详细说明
Barriers to healthy eating and active living are at the heart of the obesity epidemic. This study focuses on a key factor underlying healthy eating: home food preparation. This study aims to test the effectiveness of a community-based, peer-mentored intervention to improve home food preparation practices in families with young children. The investigators will partner with community-based organizations serving families with children ages 1 to 3 years in West Philadelphia aiming specifically to:
Test the intervention's effect on diet and physical health.
Hypothesis 1: The intervention group will have improved home food preparation practices and a healthier diet compared to the control group.
Test the intervention's effect on family health.
Hypothesis 2: The intervention group will report improved parenting skills and more hopeful patterns of thinking.
- Identify factors present at baseline and during engagement with the intervention that distinguish intervention participants who have improved diet, physical health, and family health from those who do not.
研究类型
介入性
注册 (实际的)
115
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- The Children's Hospital of Philadelphia
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria: mentees
- English-speaking
- Able to give informed consent.
- Legal guardian and caregiver of at least one child, age 1-3 years
Inclusion Criteria: children
- 1-3 year old children of mentee primary caregivers enrolled in the study
- If a mentee caregiver has more than one child, then all their eligible children (ages 1-3 years) will be enrolled in the study.
Inclusion Criteria: peer mentors
Eligible peer mentors should meet the inclusion criteria set forth above for mentees. (Children of peer mentors will not be eligible for this study.)
In addition,
- The study team will decide which participants will be invited to be peer mentors, based on attributes including interest, leadership ability, and home food preparation skills.
Exclusion Criteria
- Caregivers and children not meeting the inclusion criteria above.
- Caregivers who are pregnant at the time of enrollment.
- Caregivers or children with a medical condition that significantly affects their diet or eating habits. (The study team will ask during the time of recruitment if subjects or their children have a medical condition that significantly affects diet or eating habits.)
- Subjects who, in the opinion of the Investigator, may be unable to participate in the study schedules or procedures.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention
Behavioral: Home Plate intervention
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Home Plate is a community-based, peer mentored intervention aimed at improving home food preparation practices in families with young children.
Through 6 classes, this intervention explores topics related to regularly preparing healthy foods at home.
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实验性的：Delayed Entry Control
This Arm will receive the Home Plate intervention 3 months after the Intervention Arm completes the intervention.
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Home Plate is a community-based, peer mentored intervention aimed at improving home food preparation practices in families with young children.
Through 6 classes, this intervention explores topics related to regularly preparing healthy foods at home.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dietary Energy Density (Child Participants)
大体时间：19-30 weeks from baseline
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Child participants' 24-hour dietary recalls will be collected by trained study staff from adult caregivers.
24-hour dietary recalls will be collected on a minimum of 2 and a maximum of 3 separate days.
The results will then be used to calculate the energy density of the child's diet.
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19-30 weeks from baseline
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Home Food Preparation Practices
大体时间：19-30 weeks from baseline
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Adult participants will complete surveys to assess the foods they usually prepare at home, as well as the time, energy, and confidence they have to prepare meals for their household.
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19-30 weeks from baseline
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Home Food Environment
大体时间：19-30 weeks from baseline
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Adult participants will complete surveys to assess the foods currently available in their homes, how they feel about managing food-related tasks, and the interactions they have with their child(ren) regarding food and eating.
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19-30 weeks from baseline
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Household Routines
大体时间：19-30 weeks from baseline
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Adult participants will complete surveys to assess their household routines related to activities such as sleep, physical activity, and screen time.
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19-30 weeks from baseline
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Emotional and Family Health
大体时间：19-30 weeks from baseline
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Adult participants will complete surveys to assess the their emotional health and the health of their families.
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19-30 weeks from baseline
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Body mass index
大体时间：19-30 weeks from baseline
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Heights and weights will be measured by trained study staff and will be used to calculate body mass index (BMI) of adult and child participants.
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19-30 weeks from baseline
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Dietary Energy Density (Adult Participants)
大体时间：19-30 weeks from baseline
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24-hour dietary recalls will be collected by trained study staff from adult study participants.
24-hour dietary recalls will be collected on a minimum of 2 and a maximum of 3 separate days.
The results will then be used to calculate dietary energy density.
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19-30 weeks from baseline
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Diet Quality
大体时间：19-30 weeks from baseline
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In addition to dietary energy density, 24-hour dietary recall data will be used to calculate both child and adult study participants' intake of fruits, vegetables, whole grains, and added sugars.
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19-30 weeks from baseline
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年6月1日
初级完成 (实际的)
2017年7月1日
研究完成 (实际的)
2017年7月13日
研究注册日期
首次提交
2015年5月28日
首先提交符合 QC 标准的
2015年5月29日
首次发布 (估计)
2015年6月1日
研究记录更新
最后更新发布 (实际的)
2019年4月24日
上次提交的符合 QC 标准的更新
2019年4月22日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Home Plate的临床试验
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Gesellschaft fur Medizinische Innovation - Hamatologie...Amgen完全的
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Universidade Federal de PernambucoConselho Nacional de Desenvolvimento Científico e Tecnológico未知
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Centre Hospitalier Universitaire de Saint EtienneAssociation pour le Développement de la Recherche sur l'Appareil Locomoteur dans la Loire完全的
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University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完全的
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University Health Network, TorontoSunnybrook Health Sciences Centre; University of Toronto主动，不招人
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University of North Carolina, Chapel HillNational Institute of Nursing Research (NINR)完全的
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Universitair Ziekenhuis BrusselUniversity Ghent; Universiteit Antwerpen; Artevelde University of Applied Sciences; Odisee University...尚未招聘
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Public Health Foundation Enterprises, Inc.National Institute of Allergy and Infectious Diseases (NIAID); University of California, San... 和其他合作者完全的