Nutrition Education in Cardiac Rehabilitation

Cardiometabolic Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05198024
• Other study ID #: Nutrition Education
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: January 1, 2020

Study information

• Verified date: November 2023
• Source: University of Central Lancashire
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: January 1, 2020
• Est. primary completion date: September 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiometabolic Syndrome
• Metabolic Syndrome

Intervention

Behavioral:
• Nutrition knowledge
Nutrition knowledge either 'Usual care plus new education programme' or 'Usual care plus biggest loser'

Locations

Country	Name	City	State
United Kingdom	University of Central Lancashire	Preston	Lancashire

Sponsors (1)

Lead Sponsor	Collaborator
Jonathan Sinclair

Country where clinical trial is conducted

United Kingdom, 

Outcome

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