Growing Healthy Hearts: A Randomized Controlled Trial of a Multicomponent Gardening Intervention for Adults With Cardiovascular Disease Risk and Their Families.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Dietary Intake: Fruit and vegetable (FV) intake
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •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)
排除标准
- •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)
研究组 & 干预措施
Waitlist Control
GHH Intervention
干预措施: GHH Intervention (Behavioral)
结局指标
主要结局
Dietary Intake: Fruit and vegetable (FV) intake
时间窗: 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)
Dietary Intake: Fruit and vegetable (FV) intake
时间窗: 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)
Dietary Intake: Fruit and vegetable (FV) intake
时间窗: 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)
Dietary Intake: Fruit and vegetable (FV) intake
时间窗: 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)
次要结局
- Physical Activity - Fitbit activity volume via step count(1 year follow up)
- Physical Activity - Fitbit activity volume via step count(6 month)
- Physical Activity - Fitbit activity volume via step count(Baseline)
- Physical Activity - Fitbit activity volume via step count(3 month)
- Biomarkers - total cholesterol(Baseline)
- Biomarkers - total cholesterol(3 month)
- Biomarkers - total cholesterol(6 month)
- Biomarkers - total cholesterol(1 year follow up)
- Biomarkers - HDL(Baseline)
- Biomarkers - HDL(3 month)
- Biomarkers - HDL(6 month)
- Biomarkers - HDL(1 year follow up)
- Biomarkers -LDL(Baseline)
- Biomarkers -LDL(3 month)
- Biomarkers -LDL(6 month)
- Biomarkers -LDL(1 year follow up)
- Biomarkers -HbA1c(Baseline)
- Biomarkers -HbA1c(3 month)
- Biomarkers -HbA1c(6 month)
- Biomarkers -HbA1c(1 year follow up)
- Biomarkers -triglycerides(Baseline)
- Biomarkers -triglycerides(3 month)
- Biomarkers -triglycerides(6 month)
- Biomarkers -triglycerides(1 year follow up)
- Blood Pressure(Baseline)
- Blood Pressure(3 month)
- Blood Pressure(6 month)
- Blood Pressure(1 year follow up)
- Measure Height(Baseline)
- Measure Weight(Baseline)
- Measure Weight(3 month)
- Measure Weight(6 month)
- Measure Weight(1 year follow up)
- Nutrition Knowledge(Baseline)
- Nutrition Knowledge(3 month)
- Nutrition Knowledge(6 month)
- Nutrition Knowledge(1 year follow up)
- Household Food Security(Baseline)
- Household Food Security(3 month)
- Household Food Security(6 month)
- Household Food Security(1 year follow up)
- Home Meal Preparation(Baseline)
- Home Meal Preparation(3 month)
- Home Meal Preparation(6 month)
- Home Meal Preparation(1 year follow up)
- Cooking skills(Baseline)
- Cooking skills(3 month)
- Cooking skills(6 month)
- Cooking skills(1 year follow up)
- Social support(Baseline)
- Social support(3 month)
- Social support(6 month)
- Social support(1 year follow up)
- General Nutrition Knowledge(Baseline)
- General Nutrition Knowledge(3 month)
- General Nutrition Knowledge(6 month)
- General Nutrition Knowledge(1 year follow up)
研究者
Susan Veldheer
Associate Professor Department of Family and Community Medicine
Milton S. Hershey Medical Center