Healthy Kids & Families: Overcoming Social, Environmental and Family Barriers to Childhood Obesity Prevention
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
研究概览
详细说明
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention. Barriers include social, environmental, and family issues.
This intervention will be compared to a control condition consisting of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
The intervention uses multiple delivery modalities to maintain novelty and prevent attrition/burden. These include home visits, telephone contacts, print (literacy sensitive newsletters), social media (Facebook), and community events. Parents and children will complete scheduled assessments at baseline, 6-, 12-, 18- and 24-month follow-up.
The Specific Aims are:
Aim 1: To determine the effectiveness of the intervention compared to the control condition on child physical activity, healthy eating, BMI and utilization of built environment resources.
Aim 2: To determine the effectiveness of the intervention compared to the control condition on parent physical activity, healthy eating, BMI.
Aim 3: To examine the potential scalability of the intervention guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) model.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
Massachusetts
-
Worcester、Massachusetts、美国、01655
- UMass Medical School
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Eligible individuals for the research study are parents/guardians and their K-6th grade children attending one of 9 schools in the greater Worcester area. Parents and their children are recruited as parent-child dyads.
Exclusion Criteria:
- Has an inability or unwillingness to give informed consent or assent
- Is a prisoner
Exclusion (child only)
- The child has been told by a doctor that they cannot walk or eat fruits and vegetables.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：非随机化
- 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 |
|---|---|
|
实验性的：Healthy Lifestyles
The study will test the impact of a community health worker (CHW)-delivered intervention aimed at helping families overcome barriers to childhood obesity prevention.
Barriers include social, environmental, and family issues.
|
A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.
|
|
有源比较器：Positive Parenting
The control condition consists of a community health worker (CHW)-delivered intervention aimed at helping families improve positive parenting skills.
|
A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.
|
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 |
|---|---|---|
|
child BMI z-score
大体时间：2 years
|
Weight and height is measured using standard methodology, with children wearing light clothing and no shoes.
Weight is measured to the nearest 0.5 lb on a digital scale.
Height is measured to the nearest tenth of a centimeter using a stadiometer.
BMI is calculated: weight (kg)/height squared (meters) for age and gender using United States Centers for Disease Control and Prevention BMI charts growth charts.
|
2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Child Dietary Behaviors: Overall
大体时间：2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
|
2 years
|
|
Child Dietary Behaviors for snacks
大体时间：2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration:Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
|
2 years
|
|
Child Dietary Behaviors for Beverages
大体时间：2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
|
2 years
|
|
Parent Dietary Behaviors: Overall
大体时间：2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
|
2 years
|
|
Parent Dietary Behaviors for Snacks
大体时间：2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Snack items from the Beverage and Snack Questionnaire2 (BSQ2) (https://sharedresources.fredhutch.org/documents/beverage-and-snack-questionnaire-2)
|
2 years
|
|
Parent Dietary Behaviors for Beverages
大体时间：2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Beverage Intake Questionnaire (Hedrick et al)
|
2 years
|
|
Child Physical Activity and Sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
大体时间：2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
|
2 years
|
|
Child Physical Activity and Sedentariness: C-PAQ and PAQ-C
大体时间：2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
|
2 years
|
|
Child Physical Activity and Sedentariness: ActiGraph GT1M
大体时间：2 years
|
Child physical activity and sedentariness are measured by the child wearing the ActiGraph Model GT1M for 7 days averaged.
This measure provides data on intensity and duration of activities.
|
2 years
|
|
Parent physical activity and sedentariness: Massachusetts Parent Child Longitudinal Cohort Survey
大体时间：2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration:Selected items from the Massachusetts Parent Child Longitudinal Cohort Survey (Taveras et al., MA-CORD Study Group)
|
2 years
|
|
Parent physical activity and sedentariness: C-PAQ and PAQ-C
大体时间：2 years
|
This Outcome Measure is assessed through the following measure, modified for verbal administration: Selected items from the Physical Activity C-PAQ (Kemper et al) plus PAQ-C (Kowalski et al) activity questions
|
2 years
|
|
Parent physical activity and sedentariness: ActiGraph GT1M
大体时间：2 years
|
Parent physical activity and sedentariness are measured by the parent wearing the ActiGraph Model GT1M for 7 days averaged.
This measure provides data on intensity and duration of activities
|
2 years
|
|
Parent BMI
大体时间：2 years
|
BMI is calculated with weight and height measurements using standard methodology.
Weight is measured to the nearest 0.5 lb on a digital scale.
Height is measured to the nearest centimeter using a stadiometer.
BMI is calculated: weight (kg)/height squared (meters) for gender using United States Centers for Disease Control and Prevention BMI charts.
|
2 years
|
|
Child utilization of built environment resources
大体时间：2 years
|
Child utilization of built environment resources is assessed by the children wearing a portable GPS unit (~size of a matchbox) when wearing an accelerometer.
The GPS unit records the geographic coordinates of the child's activities.
Measures of frequency and duration of activities by neighborhood space (e.g., parks) can be ascertained.
|
2 years
|
合作者和调查者
调查人员
- 首席研究员：Milagros C Rosal, PhD、UMass Medical School
- 首席研究员：Wenjun Li, PhD、UMass Medical School
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.