ChiCTR1800014885尚未招募Unknown
A theory-based educational program to improve the cardiovascular health among Hong Kong Chinese post-menopausal women
General Research Fund, Hong Kong1 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2018年1月1日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Physical activity
研究概览
简要总结
- To examine the effects of the educational intervention on knowledge of CV health, self-efficacy and exercise, and physical activity and dietary pattern;
- To examine if the effects of the intervention on physical activity and dietary pattern are mediated through knowledge of CV health, and self-efficacy in diet and exercise;
- To examine if a positive change in physical activity and dietary pattern can result in improvements on CV health outcomes (body weight, body fat mass percentage, WC, CVD risk, fasting blood glucose, lipid profile, high sensitivity CRP, adiponectin, and IGF-1), sleep quality and vasomotor symptoms among overweight Chinese post-menopausal women in Hong Kong.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- The research assistant responsible for data collection will be blinded for group allocations of participants.
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- Female
入选标准
- •Chinese post-menopausal women aged ≤65 years [post-menopause is defined as experience of amenorrhea not attributing to other causes for at least 12 months13];
- •Being overweight or obese (BMI > 22.9 kg/m2) or with central obesity (WC > 80cm)41;
- •Able to give informed consent;
- •Attain at least 6 years of formal education.
排除标准
- •Being diagnosed with any cardiovascular disease;
- •Concurrently participating in another clinical trial, lifestyle/dietary intervention, or weight control program;
- •Concurrently using hormonal replacement therapy;
- •Known history of psychiatric disorders.
研究组 & 干预措施
1
Theory-based education
2
Usual education
结局指标
主要结局
Physical activity
时间窗: Baseline, 3-month, 6-month, 12-month
Dietary patter
时间窗: Baseline, 3-month, 6-month, 12-month
次要结局
- Cardiovascular health knowledge(Baseline, 3-month)
- Diet self-efficacy(Baseline, 3-month, 6-month, 12-month)
- Exercise self-efficacy(Baseline, 3-month, 6-month, 12-month)
- CVD risk profile(Baseline, 12-month)
- Sleep quality(Baseline, 3-month, 6-month, 12-month)
- Vasomotor symptoms(Baseline, 3-month, 6-month, 12-month)
研究者
研究点 (1)
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