NCT05180435进行中（未招募）不适用
Family Meals as a Strategy for the Primary Prevention of Cardiovascular Disease in Children
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change from baseline in diet quality.
研究概览
简要总结
The primary purpose of this study is to examine the efficacy of family meal frequency as an intervention target in addressing the primary prevention of CVD.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents who have a male or female child aged 6-12 years-old with a BMI-for-sex and age <95th percentile
- •Parent age is ≥18 years-old
- •Parent reports at least 2 of the following CVD risk factors: smoking, high cholesterol, high blood pressure, physical inactivity, overweight/obesity, diabetes
- •Parent is able to read, speak and understand English
排除标准
- •Parents who live with their child <5 days per week
- •Parents who do not have access to the internet and/or are unable to attend intervention sessions
- •Parents who report a medical condition that impacts growth or requires a specific eating plan for themselves or their child.
研究组 & 干预措施
Family Meals
Experimental
Have at least 5 dinners per week.
干预措施: Family Meals (Behavioral)
Standard
Active Comparator
Consume the recommended amounts of fruits and vegetables.
干预措施: Standard (Behavioral)
结局指标
主要结局
Change from baseline in diet quality.
时间窗: Baseline and Months 2, 6, 8 and 10
The Healthy Eating Index is a score ranging from 0-100 with higher scores indicating greater adherence to the Dietary Guidelines.
次要结局
- Change from baseline in body mass index z-scores (zBMI)(Baseline and Months 2, 6, 8 and 10)
- Change from baseline in blood pressure(Baseline and Month 6)
- Change from baseline in carotid-to-femoral pulse wave velocity (PVW)(Baseline and Month 6)
- Change from baseline in fasting insulin(Baseline and Month 6)
- Change in baseline in flow-mediated dilation (FMD)(Baseline and Month 6)
- Change from baseline in fasting glucose(Baseline and Month 6)
- Change from baseline in pulse wave analysis.(Baseline and Month 6)
- Change from baseline in lipid levels(Baseline and Month 6)
研究者
研究点 (2)
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