Growing Healthy Hearts: A Pilot Randomized Control Trial to Test Gardening as an Intervention to Improve Dietary Intake of Fruits and Vegetables and Cardiovascular Disease Risk
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Plasma Carotenoids
研究概览
简要总结
The purpose of this study is to test the effect of group-based nutrition advice plus gardening (intervention) versus group-based nutrition advice alone on dietary intake of fruits and vegetables, physical activity, and lifetime risk for cardiovascular disease (CVD).
详细描述
Study participants will be randomly assigned to attend group sessions related to gardening with nutrition advice or nutrition advice alone. The main goal of the intervention will be to encourage participants to increase their intake of fruits and vegetables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Are at least 20 years old
- •Have transportation and are willing to travel to the Hershey Community Garden
- •Have any two health conditions or risk factors for CVD. These include, but are not limited to:
- •Any history of cardiovascular disease
- •Any family history of premature cardiovascular disease
- •Any history of stroke
- •High cholesterol
- •High blood pressure
- •Overweight/obesity (BMI >=25)
- •Current or past Tobacco use
排除标准
- •Currently tends a vegetable garden
- •Moving out of the area in the next 4 months
- •Non-English speaking
- •Pregnant women
- •Participation in a past gardening study
- •Medical conditions or medications that limit ability to freely increase dietary intake of fruits and vegetables (e.g., kidney failure, dialysis)
- •A medical condition that precludes safe pursuit of gardening, i.e., recent heart conditions (e.g., heart failure, stroke, heart attack), recent or pending surgery, severe orthopedic conditions, pending hip/knee replacement, paralysis, dementia, blindness, unstable angina or uncontrolled arrhythmias, or uncontrolled asthma or allergies.
- •History of difficulty obtaining blood samples or fear of needles
结局指标
主要结局
Plasma Carotenoids
时间窗: 4 months
The primary outcome is between group differences in total plasma carotenoids from baseline to 16 weeks. Plasma carotenoids are a reliable bio-marker of dietary intake of F\&V.
Self-reported dietary intake
时间窗: 4 months
Investigators will also test the between group differences in self-reported servings of fruits and vegetables as assessed by 24-hour recalls.
次要结局
- Physical activity(4 months)
- Cardiovascular disease risk score(4 months)
研究者
Susan Veldheer
Assistant Professor, Department of Family and Community Medicine
Milton S. Hershey Medical Center