Nutrition Education in Cardiac Rehabilitation

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Nutrition Education in Cardiac Rehabilitation Patients; a 3-arm Randomized Controlled Trial

Conditions
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Cardiometabolic Syndrome

Intervention / Treatment
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* Behavioral: Nutrition knowledge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: Clinically Unstable (symptoms and medication)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Usual care<br>Where patients access to two exercise classes per week and all facilities as part of their cardiac rehabilitation. In addition to this, 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. | Behavioral: Nutrition knowledge<br>* Nutrition knowledge either 'Usual care plus new education programme' or 'Usual care plus biggest loser'<br>|
| Experimental: Usual care plus biggest loser<br>Where patients access to two exercise classes per week and all facilities as part of their cardiac rehabilitation. In addition to this, 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. | Behavioral: Nutrition knowledge<br>* Nutrition knowledge either 'Usual care plus new education programme' or 'Usual care plus biggest loser'<br>|
| Experimental: Usual care plus new education programme<br>Where patients access to two exercise classes per week and all facilities as part of their cardiac rehabilitation. In addition to this, patients in this group too part in a new education programme (anecdotally referred to as Healthy Heart Happy You) in which 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. | Behavioral: Nutrition knowledge<br>* Nutrition knowledge either 'Usual care plus new education programme' or 'Usual care plus biggest loser'<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressure - measured using a digital blood pressure monitor | Baseline | 
| Blood pressure | Systolic and diastolic blood pressure - measured using a digital blood pressure monitor | 6-weeks | 
| Blood pressure | Systolic and diastolic blood pressure - measured using a digital blood pressure monitor | 12-weeks | 
| Waist to hip ratio | Ratio of waist to hip circumference - measured using anthropocentric tape | Baseline | 
| Waist to hip ratio | Ratio of waist to hip circumference - measured using anthropocentric tape | 6-weeks | 
| Waist to hip ratio | Ratio of waist to hip circumference - measured using anthropocentric tape | 12-weeks | 
| Blood glucose | Capillary blood glucose - mmol/L | Baseline | 
| Blood glucose | Capillary blood glucose - mmol/L | 6-weeks | 
| Blood glucose | Capillary blood glucose - mmol/L | 12-weeks | 
| Blood triglycerides | Capillary blood triglycerides - mmol/L | Baseline | 
| Blood triglycerides | Capillary blood triglycerides - mmol/L | 6-weeks | 
| Blood triglycerides | Capillary blood triglycerides - mmol/L | 12-weeks | 
| Blood cholesterol | Capillary blood cholesterol - mmol/L | Baseline | 
| Blood cholesterol | Capillary blood cholesterol - mmol/L | 6-weeks | 
| Blood cholesterol | Capillary blood cholesterol - mmol/L | 12-weeks | 
| Body mass | Body mass (kg) | Baseline | 
| Body mass | Body mass (kg) | 6-weeks | 
| Body mass | Body mass (kg) | 12-weeks | 
| Body mass index | Body mass index kg/m2 | Baseline | 
| Body mass index | Body mass index kg/m2 | 6-weeks | 
| Body mass index | Body mass index kg/m2 | 12-weeks | 
| Waist circumference | Waist circumference (cm) | Baseline | 
| Waist circumference | Waist circumference (cm) | 6-weeks | 
| Waist circumference | Waist circumference (cm) | 12-weeks | 
| Mediterranean Diet score | 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. | Baseline | 
| Mediterranean Diet score | 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. | 6-weeks | 
| Mediterranean Diet score | 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. | 12-weeks | 
| Total energy | Total daily energy (kcal) taken from a 4-day diet diary | Baseline | 
| Total energy | Total daily energy (kcal) taken from a 4-day diet diary | 6-weeks | 
| Total energy | Total daily energy (kcal) taken from a 4-day diet diary | 12-weeks | 
| Calcium intake | Calcium intake per day (mg/day) taken from a 4-day diet diary | Baseline | 
| Calcium intake | Calcium intake per day (mg/day) taken from a 4-day diet diary | 6-weeks | 
| Calcium intake | Calcium intake per day (mg/day) taken from a 4-day diet diary | 12-weeks | 
| Vitamin B12 intake | Vitamin B12 (ug) intake per day taken from a 4-day diet diary | Baseline | 
| Vitamin B12 intake | Vitamin B12 (ug) intake per day taken from a 4-day diet diary | 6-weeks | 
| Vitamin B12 intake | Vitamin B12 (ug) intake per day taken from a 4-day diet diary | 12-weeks | 
| Vitamin B6 intake | Vitamin B6 (mg) intake per day taken from a 4-day diet diary | Baseline | 
| Vitamin B6 intake | Vitamin B6 (mg) intake per day taken from a 4-day diet diary | 6-weeks | 
| Vitamin B6 intake | Vitamin B6 (mg) intake per day taken from a 4-day diet diary | 12-weeks | 
| Folate intake | Folate (ug) intake per day taken from a 4-day diet diary | Baseline | 
| Folate intake | Folate (ug) intake per day taken from a 4-day diet diary | 6-weeks | 
| Folate intake | Folate (ug) intake per day taken from a 4-day diet diary | 12-weeks | 
| Vitamin A intake | Vitamin A (ug) intake per day taken from a 4-day diet diary | Baseline | 
| Vitamin A intake | Vitamin A (ug) intake per day taken from a 4-day diet diary | 6-weeks | 
| Vitamin A intake | Vitamin A (ug) intake per day taken from a 4-day diet diary | 12-weeks | 
| Vitamin C intake | Vitamin C (mg) intake per day taken from a 4-day diet diary | Baseline | 
| Vitamin C intake | Vitamin C (mg) intake per day taken from a 4-day diet diary | 6-weeks | 
| Vitamin C intake | Vitamin C (mg) intake per day taken from a 4-day diet diary | 12-weeks | 
| Vitamin D intake | Vitamin D (ug) intake per day taken from a 4-day diet diary | Baseline | 
| Vitamin D intake | Vitamin D (ug) intake per day taken from a 4-day diet diary | 6-weeks | 
| Vitamin D intake | Vitamin D (ug) intake per day taken from a 4-day diet diary | 12-weeks | 
| Vitamin E intake | Vitamin E (mg) intake per day taken from a 4-day diet diary | Baseline | 
| Vitamin E intake | Vitamin E (mg) intake per day taken from a 4-day diet diary | 6-weeks | 
| Vitamin E intake | Vitamin E (mg) intake per day taken from a 4-day diet diary | 12-weeks | 
| Thiamine intake | Thiamine (mg) intake per day taken from a 4-day diet diary | Baseline | 
| Thiamine intake | Thiamine (mg) intake per day taken from a 4-day diet diary | 6-weeks | 
| Thiamine intake | Thiamine (mg) intake per day taken from a 4-day diet diary | 12-weeks | 
| Riboflavin intake | Riboflavin (mg) intake per day taken from a 4-day diet diary | Baseline | 
| Riboflavin intake | Riboflavin (mg) intake per day taken from a 4-day diet diary | 6-weeks | 
| Riboflavin intake | Riboflavin (mg) intake per day taken from a 4-day diet diary | 12-weeks | 
| Selenium intake | Selenium (ug) intake per day taken from a 4-day diet diary | Baseline | 
| Selenium intake | Selenium (ug) intake per day taken from a 4-day diet diary | 6-weeks | 
| Selenium intake | Selenium (ug) intake per day taken from a 4-day diet diary | 12-weeks | 
| Zinc intake | Zinc (mg) intake per day taken from a 4-day diet diary | Baseline | 
| Zinc intake | Zinc (mg) intake per day taken from a 4-day diet diary | 6-weeks | 
| Zinc intake | Zinc (mg) intake per day taken from a 4-day diet diary | 12-weeks | 
| Sodium intake | Sodium (mg) intake per day taken from a 4-day diet diary | Baseline | 
| Sodium intake | Sodium (mg) intake per day taken from a 4-day diet diary | 6-weeks | 
| Sodium intake | Sodium (mg) intake per day taken from a 4-day diet diary | 12-weeks | 
| Carbohydrate intake | Carbohydrate (g) intake per day taken from a 4-day diet diary | Baseline | 
| Carbohydrate intake | Carbohydrate (g) intake per day taken from a 4-day diet diary | 6-weeks | 
| Carbohydrate intake | Carbohydrate (g) intake per day taken from a 4-day diet diary | 12-weeks | 
| Fat intake | Fat (g) intake per day taken from a 4-day diet diary | Baseline | 
| Fat intake | Fat (g) intake per day taken from a 4-day diet diary | 6-weeks | 
| Fat intake | Fat (g) intake per day taken from a 4-day diet diary | 12-weeks | 
| Sugar intake | Sugar (g) intake per day taken from a 4-day diet diary | Baseline | 
| Sugar intake | Sugar (g) intake per day taken from a 4-day diet diary | 6-weeks | 
| Sugar intake | Sugar (g) intake per day taken from a 4-day diet diary | 12-weeks | 
| Fibre intake | Fibre (g) intake per day taken from a 4-day diet diary | Baseline | 
| Fibre intake | Fibre (g) intake per day taken from a 4-day diet diary | 6-weeks | 
| Fibre intake | Fibre (g) intake per day taken from a 4-day diet diary | 12-weeks | 
| Starch intake | Starch (g) intake per day taken from a 4-day diet diary | Baseline | 
| Starch intake | Starch (g) intake per day taken from a 4-day diet diary | 6-weeks | 
| Starch intake | Starch (g) intake per day taken from a 4-day diet diary | 12-weeks | 
| Protein intake | Protein (g) intake per day taken from a 4-day diet diary | Baseline | 
| Protein intake | Protein (g) intake per day taken from a 4-day diet diary | 6-weeks | 
| Protein intake | Protein (g) intake per day taken from a 4-day diet diary | 12-weeks | 
| Saturated fat intake | Saturated fat (g) intake per day taken from a 4-day diet diary | Baseline | 
| Saturated fat intake | Saturated fat (g) intake per day taken from a 4-day diet diary | 6-weeks | 
| Saturated fat intake | Saturated fat (g) intake per day taken from a 4-day diet diary | 12-weeks | 
| Monounsaturated fat intake | Monounsaturated fat (g) intake per day taken from a 4-day diet diary | Baseline | 
| Monounsaturated fat intake | Monounsaturated fat (g) intake per day taken from a 4-day diet diary | 6-weeks | 
| Monounsaturated fat intake | Monounsaturated fat (g) intake per day taken from a 4-day diet diary | 12-weeks | 
| Polyunsaturated fat intake | Polyunsaturated fat (g) intake per day taken from a 4-day diet diary | Baseline | 
| Polyunsaturated fat intake | Polyunsaturated fat (g) intake per day taken from a 4-day diet diary | 6-weeks | 
| Polyunsaturated fat intake | Polyunsaturated fat (g) intake per day taken from a 4-day diet diary | 12-weeks |