ChiCTR-IOR-17012512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
- Dietary Pattern
研究概览
简要总结
The study aims to examine the effects and mechanisms of a theory-based educational program on physical activity and dietary pattern, and cardiovascular health among overweight Chinese post-menopausal women in Hong Kong. We hypothesize that:
- To compare with the control group receiving conventional didactic education, our theory-based educational program shows significant improvements on knowledge of CV health, self-efficacy in diet and exercise, and PA and dietary pattern at 3-month, 6-month and 12-month after entering the study;
- the effects of the theory-based educational intervention on PA and dietary pattern are mediated through knowledge of CV health, and self-efficacy in diet and exercise;
- positive changes in PA and dietary pattern can result in improvements on CV health outcomes (fasting blood glucose, lipid profile, CRP, adiponectin, and IGF-1, body weight, body fat mass percentage, WC, Framingham CVD risk score), sleep quality, and vasomotor symptoms.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
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 months];
- •Being overweight or obese (Body Mass Index > 22.9 kg/m2) or with central obesity (Waist Circumference > 80cm)
- •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
Didactic education
2
Theory-based education
结局指标
主要结局
Dietary Pattern
时间窗: Baseline, 3, 6 and 12 months after the study entry
Physical Activity Pattern
时间窗: Baseline, 3, 6 and 12 months after the study entry
次要结局
- Cardiovascular knowledge(Baseline and 3 months after the study entry)
- Self-efficacy in diet(Baseline, 3, 6 and 12 months after the study entry)
- Self-efficacy in physical activity(Baseline, 3, 6 and 12 months after the study entry)
- Blood pressure(Baseline, 3, 6 and 12 months after the study entry)
- Waist circumference(Baseline, 3, 6 and 12 months after the study entry)
- Body weight and body fat mass percentage(Baseline, 3, 6 and 12 months after the study entry)
- Cardiovascular blood outcomes(Baseline and 12 months after the study entry)
- Sleep quality(Baseline, 3, 6 and 12 months after the study entry)
- Vasomotor symptoms(Baseline, 3, 6 and 12 months after the study entry)
- General Health Literacy(Baseline)
研究者
研究点 (1)
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