Growing Healthy Hearts (GHH)
2026年7月2日 更新者：Susan Veldheer、Milton S. Hershey Medical Center
Growing Healthy Hearts: A Randomized Controlled Trial of a Multicomponent Gardening Intervention for Adults With Cardiovascular Disease Risk and Their Families.
This proposal includes a prospective, parallel group, two-arm RCT with 264 adult-child dyads (adult age 18+, child ages 5-17 years) to examine the effectiveness of the Growing Healthy Hearts (GHH) intervention versus a wait list control on cardiovascular and behavioral health outcomes at 3-, 6- and 12-months follow-up (Aim 1).
This proposal will also examine the effect of GHH on home fruit and vegetable (FV) availability, frequency of home-prepared meals that include FV, and child behaviors (FV intake and PA) at 3-, 6- and 12-month follow-up (Aim 2) and intervention implementation (Aim 3)
研究概览
研究类型
介入性
注册 (估计的)
264
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。
学习联系方式
- 姓名：Susan Veldheer, DEd, RD
- 电话号码：717-531-5625
- 邮箱：sveldheer@psu.edu
研究联系人备份
- 姓名：Kayla Rutt, DrPH
- 电话号码：717-858-6204
- 邮箱：krutt1@pennstatehealth.psu.edu
学习地点
-
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Pennsylvania
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Hershey、Pennsylvania、美国、17033
- Penn State College of Medicine
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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
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Adults aged 18 or older who are interested in gardening but have no plans to garden in the coming season.
- Participants will also be required to: 1) have at least one child (aged 5-17) living in the household with them
- Have access to space for a garden (either at home or in a community garden space where they could plant any combination of in-ground, raised beds, and/or container gardens
- Have a smartphone capable of downloading an app and syncing with a Fitbit
- Access to the internet
- Have or are willing to create a Facebook account
- Report ≤90 minutes of moderate or vigorous physical activity /week
- Report <5 servings of fruit and vegetables per day
- Have any one additional self-reported CVD risk factor (e.g., BMI ≥25, family history of premature CVD, high blood pressure, high cholesterol, diabetes, current or past tobacco use)
Exclusion Criteria:
- Adults who are pregnant
- Have medical conditions that significantly limit an individual's ability to participate in gardening (e.g., knee or back pain, heart attack/stroke in the past year, recent or pending surgeries
- Uncontrolled allergies, other serious physical disabilities, uncontrolled asthma)
- Medical conditions that may limit participants from increasing FV intake (e.g., kidney failure or dialysis)
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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无干预：候补名单控制
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|
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实验性的：GHH Intervention
|
This intervention examines the effectiveness of the Growing Healthy Hearts (GHH) intervention versus a wait list control on cardiovascular and behavioral health outcomes at 3-, 6- and 12-months follow-up.
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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 |
|---|---|---|
|
Dietary Intake: Fruit and vegetable (FV) intake
大体时间：Baseline
|
Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points.
Diet data will be analyzed using the Nutrition Data System for Research (NDSR)
|
Baseline
|
|
Dietary Intake: Fruit and vegetable (FV) intake
大体时间：3 month
|
Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points.
Data will be analyzed using the Nutrition Data System for Research (NDSR)
|
3 month
|
|
Dietary Intake: Fruit and vegetable (FV) intake
大体时间：6 month
|
Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points.
Data will be analyzed using the Nutrition Data System for Research (NDSR)
|
6 month
|
|
Dietary Intake: Fruit and vegetable (FV) intake
大体时间：1 year follow up
|
Trained interviewers at the Penn State Diet Assessment Center, will collect 24-hour dietary recalls (one weekday and one weekend day) by phone within one week of each scheduled study visit at 4 time points.
Data will be analyzed using the Nutrition Data System for Research (NDSR)
|
1 year follow up
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Physical Activity - Fitbit activity volume via step count
大体时间：Baseline
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
Baseline
|
|
Physical Activity - Fitbit activity volume via step count
大体时间：3 month
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
3 month
|
|
Physical Activity - Fitbit activity volume via step count
大体时间：6 month
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
6 month
|
|
Physical Activity - Fitbit activity volume via step count
大体时间：1 year follow up
|
This data will be collected via wrist worn Fitbit Inspire 3 devices
|
1 year follow up
|
|
Biomarkers - total cholesterol
大体时间：Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers - total cholesterol
大体时间：3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers - total cholesterol
大体时间：6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers - total cholesterol
大体时间：1 year follow up
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
1 year follow up
|
|
Biomarkers - HDL
大体时间：Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers - HDL
大体时间：3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers - HDL
大体时间：6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers - HDL
大体时间：1 year follow up
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
1 year follow up
|
|
Biomarkers -LDL
大体时间：Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -LDL
大体时间：3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -LDL
大体时间：6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -LDL
大体时间：1 year follow up
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
1 year follow up
|
|
Biomarkers -HbA1c
大体时间：Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -HbA1c
大体时间：3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -HbA1c
大体时间：6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -HbA1c
大体时间：1 year follow up
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
1 year follow up
|
|
Biomarkers -triglycerides
大体时间：Baseline
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
Baseline
|
|
Biomarkers -triglycerides
大体时间：3 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
3 month
|
|
Biomarkers -triglycerides
大体时间：6 month
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
6 month
|
|
Biomarkers -triglycerides
大体时间：1 year follow up
|
These at-home, blood collection devices will be used to collect results for markers of cardiometabolic disease
|
1 year follow up
|
|
Blood Pressure
大体时间：Baseline
|
The blood pressure cuffs will be used to monitor participants' cardiovascular health.
These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.
|
Baseline
|
|
Blood Pressure
大体时间：3 month
|
The blood pressure cuffs will be used to monitor participants' cardiovascular health.
These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.
|
3 month
|
|
Blood Pressure
大体时间：6 month
|
The blood pressure cuffs will be used to monitor participants' cardiovascular health.
These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.
|
6 month
|
|
Blood Pressure
大体时间：1 year follow up
|
The blood pressure cuffs will be used to monitor participants' cardiovascular health.
These devices will be used to collect blood pressure data at baseline, midpoint, and follow-up assessments.
|
1 year follow up
|
|
Measure Height
大体时间：Baseline
|
Height measurement tools will be used to assess changes in participant height for BMI calculation.
|
Baseline
|
|
Measure Weight
大体时间：Baseline
|
Scales will be used to measure participants' weight and monitor changes in weight status.
Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions.
This will be collected on adults and children
|
Baseline
|
|
Measure Weight
大体时间：3 month
|
Scales will be used to measure participants' weight and monitor changes in weight status.
Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions.
This will be collected on adults and children
|
3 month
|
|
Measure Weight
大体时间：6 month
|
Scales will be used to measure participants' weight and monitor changes in weight status.
Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions.
This will be collected on adults and children
|
6 month
|
|
Measure Weight
大体时间：1 year follow up
|
Scales will be used to measure participants' weight and monitor changes in weight status.
Accurate weight measurements are essential for Aim 1 to assess the participants' risk for obesity and other cardiovascular conditions.
This will be collected on adults and children
|
1 year follow up
|
|
Household Food Security
大体时间：Baseline
|
18-item United States Household Food Security Survey Module will assess home food security for adults and children.
Scale yields scores from 0-18 with lower scores indicating higher food security.
|
Baseline
|
|
Household Food Security
大体时间：3 month
|
18-item United States Household Food Security Survey Module will assess home food security for adults and children.
Scale yields scores from 0-18 with lower scores indicating higher food security.
|
3 month
|
|
Household Food Security
大体时间：6 month
|
18-item United States Household Food Security Survey Module will assess home food security for adults and children.
Scale yields scores from 0-18 with lower scores indicating higher food security.
|
6 month
|
|
Household Food Security
大体时间：1 year follow up
|
18-item United States Household Food Security Survey Module will assess home food security for adults and children.
Scale yields scores from 0-18 with lower scores indicating higher food security.
|
1 year follow up
|
|
General Nutrition Knowledge
大体时间：Baseline
|
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
|
Baseline
|
|
General Nutrition Knowledge
大体时间：3 month
|
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome).
|
3 month
|
|
General Nutrition Knowledge
大体时间：6 month
|
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
|
6 month
|
|
General Nutrition Knowledge
大体时间：1 year follow up
|
General Nutrition Knowledge Questionnaire will assess knowledge of general healthy eating information (score range 0-35, where higher score means a better outcome)
|
1 year follow up
|
|
Home Meal Preparation
大体时间：Baseline
|
The National Health and Nutrition Examination Survey (NHANES) Home meal preparation questionnaire will assess the number of evening meals prepared per week (range 0-7 with higher number equating to more evening meals prepared).
|
Baseline
|
|
Home Meal Preparation
大体时间：3 month
|
The National Health and Nutrition Examination Survey (NHANES) Home meal preparation questionnaire will assess the number of evening meals prepared per week (range 0-7 with higher number equating to more evening meals prepared).
|
3 month
|
|
Home Meal Preparation
大体时间：6 month
|
The National Health and Nutrition Examination Survey (NHANES) Home meal preparation questionnaire will assess the number of evening meals prepared per week (range 0-7 with higher number equating to more evening meals prepared).
|
6 month
|
|
Home Meal Preparation
大体时间：1 year follow up
|
The National Health and Nutrition Examination Survey (NHANES) Home meal preparation questionnaire will assess the number of evening meals prepared per week (range 0-7 with higher number equating to more evening meals prepared).
|
1 year follow up
|
|
Cooking skills
大体时间：Baseline
|
The Cooking and Food Skills Questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
|
Baseline
|
|
Cooking skills
大体时间：3 month
|
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
|
3 month
|
|
Cooking skills
大体时间：6 month
|
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
|
6 month
|
|
Cooking skills
大体时间：1 year follow up
|
The Cooking and Food Skills questionnaire yields a total score with a range from 33-231 with higher scores indicating better skills.
|
1 year follow up
|
|
Social support
大体时间：Baseline
|
The Social Support for Diet and Exercise Behavior survey measures social support from friends and family with higher scores indicating more social support for these behaviors (score range 0-115).
|
Baseline
|
|
Social support
大体时间：3 month
|
The Social Support for Diet and Exercise Behavior survey measures social support from friends and family with higher scores indicating more social support for these behaviors (score range 0-115).
|
3 month
|
|
Social support
大体时间：6 month
|
The Social Support for Diet and Exercise Behavior survey measures social support from friends and family with higher scores indicating more social support for these behaviors (score range 0-115).
|
6 month
|
|
Social support
大体时间：1 year follow up
|
The Social Support for Diet and Exercise Behavior survey measures social support from friends and family with higher scores indicating more social support for these behaviors (score range 0-115).
|
1 year follow up
|
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 (估计的)
2026年10月1日
初级完成 (估计的)
2030年10月1日
研究完成 (估计的)
2031年3月1日
研究注册日期
首次提交
2026年6月29日
首先提交符合 QC 标准的
2026年6月29日
首次发布 (实际的)
2026年7月6日
研究记录更新
最后更新发布 (实际的)
2026年7月7日
上次提交的符合 QC 标准的更新
2026年7月2日
最后验证
2026年7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.