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Nutrition Education in Cardiac Rehabilitation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05198024
Enrollment
64
Registered
2022-01-20
Start date
2018-01-01
Completion date
2020-01-01
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiometabolic Syndrome

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.

Interventions

BEHAVIORALNutrition knowledge

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

Sponsors

Jonathan Sinclair
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Blood pressureBaselineSystolic and diastolic blood pressure - measured using a digital blood pressure monitor
Waist to hip ratioBaselineRatio of waist to hip circumference - measured using anthropocentric tape
Blood glucoseBaselineCapillary blood glucose - mmol/L
Blood triglyceridesBaselineCapillary blood triglycerides - mmol/L
Blood cholesterolBaselineCapillary blood cholesterol - mmol/L
Body massBaselineBody mass (kg)
Body mass indexBaselineBody mass index kg/m2
Waist circumferenceBaselineWaist circumference (cm)
Mediterranean Diet scoreBaselineMediterranean 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.
Total energyBaselineTotal daily energy (kcal) taken from a 4-day diet diary
Calcium intakeBaselineCalcium intake per day (mg/day) taken from a 4-day diet diary
Vitamin B12 intakeBaselineVitamin B12 (ug) intake per day taken from a 4-day diet diary
Vitamin B6 intakeBaselineVitamin B6 (mg) intake per day taken from a 4-day diet diary
Folate intakeBaselineFolate (ug) intake per day taken from a 4-day diet diary
Vitamin A intakeBaselineVitamin A (ug) intake per day taken from a 4-day diet diary
Vitamin C intakeBaselineVitamin C (mg) intake per day taken from a 4-day diet diary
Vitamin D intakeBaselineVitamin D (ug) intake per day taken from a 4-day diet diary
Vitamin E intakeBaselineVitamin E (mg) intake per day taken from a 4-day diet diary
Thiamine intakeBaselineThiamine (mg) intake per day taken from a 4-day diet diary
Riboflavin intakeBaselineRiboflavin (mg) intake per day taken from a 4-day diet diary
Selenium intakeBaselineSelenium (ug) intake per day taken from a 4-day diet diary
Zinc intakeBaselineZinc (mg) intake per day taken from a 4-day diet diary
Sodium intakeBaselineSodium (mg) intake per day taken from a 4-day diet diary
Carbohydrate intakeBaselineCarbohydrate (g) intake per day taken from a 4-day diet diary
Fat intakeBaselineFat (g) intake per day taken from a 4-day diet diary
Sugar intakeBaselineSugar (g) intake per day taken from a 4-day diet diary
Fibre intakeBaselineFibre (g) intake per day taken from a 4-day diet diary
Starch intakeBaselineStarch (g) intake per day taken from a 4-day diet diary
Protein intakeBaselineProtein (g) intake per day taken from a 4-day diet diary
Saturated fat intakeBaselineSaturated fat (g) intake per day taken from a 4-day diet diary
Monounsaturated fat intakeBaselineMonounsaturated fat (g) intake per day taken from a 4-day diet diary
Polyunsaturated fat intakeBaselinePolyunsaturated fat (g) intake per day taken from a 4-day diet diary

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026