Effects of Nutrition Education in Cardiac Rehabilitation Patients; a 3-arm Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
Coronary heart disease is one of the United Kingdom's biggest killers. In the UK alone 175,000 myocardial infarctions are recorded annually. To lower the financial burden on the National Health Service, cardiac rehabilitation facilitates a systematic and multidisciplinary approach to secondary prevention aimed to improve functional capacity and health-related quality of life, lower rehospitalisation rates and reduce all-cause and cardiovascular mortality with exercise training being the cornerstones. The effectiveness of
Cardiac rehabilitation programmes in delivering effective secondary prevention has long been established. Improvements are recorded in cardiovascular endurance, muscular strength and endurance, balance, co-ordination, and quality of life. However, many patients see little or no change in body mass and body mass index, an independent risk factor for coronary heart disease. Interestingly, the inclusion of nutrition education is rarely reported within specific Cardiac rehabilitation settings, therefore evidence of best practice remains elusive and warrants further investigation.
The aim of this trial is to compare:
- Usual care - Where patients access to two exercise classes per week and all facilities normally available as part of their cardiac rehabilitation programme. Patients in this group will undergo this approach for 12-weeks.
- Usual care + Biggest loser - In addition to Usual care, patients in this group took part in the 'Biggest loser' program in which the patients attended weekly sessions outside of their usual exercise class times. Each session follows a specific theme based on British Heart Foundation healthy eating guidelines. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks.
- Usual care + New Education programme. In addition to Usual care, the same weekly topics as the biggest loser are covered yet with bespoke information regarding portion sizes and recipes provided each week and patients given a challenge each week in relation to the topic being covered e.g. include more vegetables. Participants will undergo this approach for 6-weeks and then switch to usual care for 6-weeks.
Patients will be tested at baseline, 6-weeks and 12-weeks.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to give informed consent
- •Engaged in phase IV cardiac rehabilitation program
- •Patient has read and understood the Patient Information Sheet
- •Clinically stable (symptoms and medication)
排除标准
- •Clinically Unstable (symptoms and medication)
结局指标
主要结局
Blood pressure
时间窗: 12-weeks
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Calcium intake
时间窗: 12-weeks
Calcium intake per day (mg/day) taken from a 4-day diet diary
Waist to hip ratio
时间窗: 12-weeks
Ratio of waist to hip circumference - measured using anthropocentric tape
Body mass index
时间窗: 12-weeks
Body mass index kg/m2
Waist circumference
时间窗: 12-weeks
Waist circumference (cm)
Total energy
时间窗: 12-weeks
Total daily energy (kcal) taken from a 4-day diet diary
Vitamin B6 intake
时间窗: 12-weeks
Vitamin B6 (mg) intake per day taken from a 4-day diet diary
Mediterranean Diet score
时间窗: 12-weeks
Mediterranean score obtained from the Mediterranean Diet Assessment tool. A lower score means higher risk from cardiovascular disease. The scale has a score range from 0-14.
Vitamin B12 intake
时间窗: 12-weeks
Vitamin B12 (ug) intake per day taken from a 4-day diet diary
Vitamin A intake
时间窗: 12-weeks
Vitamin A (ug) intake per day taken from a 4-day diet diary
Blood glucose
时间窗: 12-weeks
Capillary blood glucose - mmol/L
Blood triglycerides
时间窗: 12-weeks
Capillary blood triglycerides - mmol/L
Blood cholesterol
时间窗: 12-weeks
Capillary blood cholesterol - mmol/L
Body mass
时间窗: 12-weeks
Body mass (kg)
Vitamin C intake
时间窗: 12-weeks
Vitamin C (mg) intake per day taken from a 4-day diet diary
Folate intake
时间窗: 12-weeks
Folate (ug) intake per day taken from a 4-day diet diary
Fibre intake
时间窗: 12-weeks
Fibre (g) intake per day taken from a 4-day diet diary
Saturated fat intake
时间窗: 12-weeks
Saturated fat (g) intake per day taken from a 4-day diet diary
Vitamin D intake
时间窗: 12-weeks
Vitamin D (ug) intake per day taken from a 4-day diet diary
Sodium intake
时间窗: 12-weeks
Sodium (mg) intake per day taken from a 4-day diet diary
Monounsaturated fat intake
时间窗: 12-weeks
Monounsaturated fat (g) intake per day taken from a 4-day diet diary
Vitamin E intake
时间窗: 12-weeks
Vitamin E (mg) intake per day taken from a 4-day diet diary
Thiamine intake
时间窗: 12-weeks
Thiamine (mg) intake per day taken from a 4-day diet diary
Riboflavin intake
时间窗: 12-weeks
Riboflavin (mg) intake per day taken from a 4-day diet diary
Selenium intake
时间窗: 12-weeks
Selenium (ug) intake per day taken from a 4-day diet diary
Zinc intake
时间窗: 12-weeks
Zinc (mg) intake per day taken from a 4-day diet diary
Carbohydrate intake
时间窗: 12-weeks
Carbohydrate (g) intake per day taken from a 4-day diet diary
Fat intake
时间窗: 12-weeks
Fat (g) intake per day taken from a 4-day diet diary
Sugar intake
时间窗: 12-weeks
Sugar (g) intake per day taken from a 4-day diet diary
Starch intake
时间窗: 12-weeks
Starch (g) intake per day taken from a 4-day diet diary
Protein intake
时间窗: 12-weeks
Protein (g) intake per day taken from a 4-day diet diary
Polyunsaturated fat intake
时间窗: 12-weeks
Polyunsaturated fat (g) intake per day taken from a 4-day diet diary
次要结局
未报告次要终点
研究者
Jonathan Sinclair
Professor
University of Central Lancashire