NCT06380218招募中不适用
Evaluation of Nutritional Prevention Program for Women's Cardiovascular Health on Quality of Life (SAFE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
研究概览
简要总结
The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women at risk of cardiovascular disease after 10 group coaching sessions in nutrition and physical activity.
详细描述
The objective is to evaluate the effect of a nutritional prevention program associated with the consumption of "Primevère margarine" on the quality of life of women aged 40 to 65 with cardiovascular risk 3 months after 10 group coaching sessions.
The nutritional prevention program includes tools and 10 collective workshops to change the life behaviours (eating habits and physical activity) by assessing :
- Food balance and diversity
- Eating behaviour and representations
- Level of knowledge in nutrition
- Level of physical activity and physical inactivity
- Physical abilities: strength, balance, flexibility, cardio respiratory endurance, recovery capacity
- Behavioural barriers and educational levers to improve women's cardiovascular health
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •BMI > 25kg/m² and/or with a waist circumference > 88 cm
- •Regularly consuming butter and/or "standard" margarine rich in saturated fatty acids
排除标准
- •Regularly consuming "healthy" margarine enriched with omega 3 (Primevere, St Hubert ω3 ...) or with phytosterols (Pro-active)
- •Consuming omega-3 rich food supplements within 3 months of inclusion
- •Treated with lipid-lowering agents (statins), antidiabetic or antihypertensive drugs for less than 3 months
- •Suffering of eating disorders
- •Presenting a medical contraindication to the practice of physical activity
- •Having previously participated in a similar prevention program
- •Suffering from serious chronic diseases (cancer, serious cardiovascular history, etc.)
结局指标
主要结局
Change from baseline on quality of life of women with cardiovascular risk at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"
时间窗: At 3 months after the coaching session
Quality of Life Questionnaire Short Form-36 validated by World Health Organization (WHO)
次要结局
- Change from baseline on life behaviours at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on well-being at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on food and physical activity knowledge at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on motivation to change behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on stress management at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on physical behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on recovery capacity at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on static balance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on flexibility at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on handgrip strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on lower limb strengh at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on lipids metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on waist circumference at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on endurance at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on BMI at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on glucose metabolism at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on body composition at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on systolic and diastolic blood pressure at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
- Change from baseline on cardiovascular risk at 3 months after a nutritional prevention program(At 3 months after the coaching session)
- Satisfaction of Primevere products(On the last coaching session - 10 weeks)
- Change from baseline on food behaviors at 3 months after a nutritional prevention program associated with the consumption of "Primevère margarine"(At 3 months after the coaching session)
研究者
Jean-Michel Lecerf
Principal Invesigator
Institut Pasteur de Lille
研究点 (2)
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