Clinical trial NCT05198024: Nutrition Education in Cardiac Rehabilitation
Official title: Effects of Nutrition Education in Cardiac Rehabilitation Patients; a 3-arm Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiometabolic Syndrome
Lead sponsor: University of Central Lancashire
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Blood pressure
timeFrame: Baseline
measure: Blood pressure
timeFrame: 6-weeks
measure: Blood pressure
timeFrame: 12-weeks
measure: Waist to hip ratio
timeFrame: Baseline
measure: Waist to hip ratio
timeFrame: 6-weeks
measure: Waist to hip ratio
timeFrame: 12-weeks
measure: Blood glucose
timeFrame: Baseline
measure: Blood glucose
timeFrame: 6-weeks
measure: Blood glucose
timeFrame: 12-weeks
measure: Blood triglycerides
timeFrame: Baseline
measure: Blood triglycerides
timeFrame: 6-weeks
measure: Blood triglycerides
timeFrame: 12-weeks
measure: Blood cholesterol
timeFrame: Baseline
measure: Blood cholesterol
timeFrame: 6-weeks
measure: Blood cholesterol
timeFrame: 12-weeks
measure: Body mass
timeFrame: Baseline
measure: Body mass
timeFrame: 6-weeks
measure: Body mass
timeFrame: 12-weeks
measure: Body mass index
timeFrame: Baseline
measure: Body mass index
timeFrame: 6-weeks
measure: Body mass index
timeFrame: 12-weeks
measure: Waist circumference
timeFrame: Baseline
measure: Waist circumference
timeFrame: 6-weeks
measure: Waist circumference
timeFrame: 12-weeks
measure: Mediterranean Diet score
timeFrame: Baseline
measure: Mediterranean Diet score
timeFrame: 6-weeks
measure: Mediterranean Diet score
timeFrame: 12-weeks
measure: Total energy
timeFrame: Baseline
measure: Total energy
timeFrame: 6-weeks
measure: Total energy
timeFrame: 12-weeks
measure: Calcium intake
timeFrame: Baseline
measure: Calcium intake
timeFrame: 6-weeks
measure: Calcium intake
timeFrame: 12-weeks
measure: Vitamin B12 intake
timeFrame: Baseline
measure: Vitamin B12 intake
timeFrame: 6-weeks
measure: Vitamin B12 intake
timeFrame: 12-weeks
measure: Vitamin B6 intake
timeFrame: Baseline
measure: Vitamin B6 intake
timeFrame: 6-weeks
measure: Vitamin B6 intake
timeFrame: 12-weeks
measure: Folate intake
timeFrame: Baseline
measure: Folate intake
timeFrame: 6-weeks
measure: Folate intake
timeFrame: 12-weeks
measure: Vitamin A intake
timeFrame: Baseline
measure: Vitamin A intake
timeFrame: 6-weeks
measure: Vitamin A intake
timeFrame: 12-weeks
measure: Vitamin C intake
timeFrame: Baseline
measure: Vitamin C intake
timeFrame: 6-weeks
measure: Vitamin C intake
timeFrame: 12-weeks
measure: Vitamin D intake
timeFrame: Baseline
measure: Vitamin D intake
timeFrame: 6-weeks
measure: Vitamin D intake
timeFrame: 12-weeks
measure: Vitamin E intake
timeFrame: Baseline
measure: Vitamin E intake
timeFrame: 6-weeks
measure: Vitamin E intake
timeFrame: 12-weeks
measure: Thiamine intake
timeFrame: Baseline
measure: Thiamine intake
timeFrame: 6-weeks
measure: Thiamine intake
timeFrame: 12-weeks
measure: Riboflavin intake
timeFrame: Baseline
measure: Riboflavin intake
timeFrame: 6-weeks
measure: Riboflavin intake
timeFrame: 12-weeks
measure: Selenium intake
timeFrame: Baseline
measure: Selenium intake
timeFrame: 6-weeks
measure: Selenium intake
timeFrame: 12-weeks
measure: Zinc intake
timeFrame: Baseline
measure: Zinc intake
timeFrame: 6-weeks
measure: Zinc intake
timeFrame: 12-weeks
measure: Sodium intake
timeFrame: Baseline
measure: Sodium intake
timeFrame: 6-weeks
measure: Sodium intake
timeFrame: 12-weeks
measure: Carbohydrate intake
timeFrame: Baseline
measure: Carbohydrate intake
timeFrame: 6-weeks
measure: Carbohydrate intake
timeFrame: 12-weeks
measure: Fat intake
timeFrame: Baseline
measure: Fat intake
timeFrame: 6-weeks
measure: Fat intake
timeFrame: 12-weeks
measure: Sugar intake
timeFrame: Baseline
measure: Sugar intake
timeFrame: 6-weeks
measure: Sugar intake
timeFrame: 12-weeks
measure: Fibre intake
timeFrame: Baseline
measure: Fibre intake
timeFrame: 6-weeks
measure: Fibre intake
timeFrame: 12-weeks
measure: Starch intake
timeFrame: Baseline
measure: Starch intake
timeFrame: 6-weeks
measure: Starch intake
timeFrame: 12-weeks
measure: Protein intake
timeFrame: Baseline
measure: Protein intake
timeFrame: 6-weeks
measure: Protein intake
timeFrame: 12-weeks
measure: Saturated fat intake
timeFrame: Baseline
measure: Saturated fat intake
timeFrame: 6-weeks
measure: Saturated fat intake
timeFrame: 12-weeks
measure: Monounsaturated fat intake
timeFrame: Baseline
measure: Monounsaturated fat intake
timeFrame: 6-weeks
measure: Monounsaturated fat intake
timeFrame: 12-weeks
measure: Polyunsaturated fat intake
timeFrame: Baseline
measure: Polyunsaturated fat intake
timeFrame: 6-weeks
measure: Polyunsaturated fat intake
timeFrame: 12-weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Preston
country: United Kingdom
facility: University of Central Lancashire
state: Lancashire
Study officials:
References: