Nutrition Education in Cardiac Rehabilitation

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiometabolic Syndrome
• Intervention / Treatment: Behavioral: Nutrition knowledge

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Lancashire
    • Preston, Lancashire, United Kingdom, PR4 0PE
      • University of Central Lancashire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Usual care; 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; Nutrition knowledge either 'Usual care plus new education programme' or 'Usual care plus biggest loser'
Experimental: Usual care plus biggest loser; 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; Nutrition knowledge either 'Usual care plus new education programme' or 'Usual care plus biggest loser'
Experimental: Usual care plus new education programme; 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; Nutrition knowledge either 'Usual care plus new education programme' or 'Usual care plus biggest loser'

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Waist circumference (cm)	Baseline
Blood pressure	Systolic and diastolic blood pressure - measured using a digital blood pressure monitor	Baseline
Waist to hip ratio	Ratio of waist to hip circumference - measured using anthropocentric tape	Baseline
Blood glucose	Capillary blood glucose - mmol/L	Baseline
Blood triglycerides	Capillary blood triglycerides - mmol/L	Baseline
Blood cholesterol (Total, HDL & LDL)	Capillary blood cholesterol - mmol/L	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	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	6-weeks
Blood glucose	Capillary blood glucose - mmol/L	12-weeks
Blood triglycerides	Capillary blood triglycerides - mmol/L	6-weeks
Blood triglycerides	Capillary blood triglycerides - mmol/L	12-weeks
Blood cholesterol (Total, HDL & LDL)	Capillary blood cholesterol - mmol/L	6-weeks
Blood cholesterol (Total, HDL & LDL)	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)	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

Collaborators and Investigators

• Sponsor: Jonathan Sinclair

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: December 16, 2021
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 20, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: Nutrition Education

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No