Nutrition Education in Cardiac Rehabilitation

NCT ID: NCT05198024

Last Updated: 2023-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2020-01-01

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.

Conditions

Cardiometabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Nutrition knowledge

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Nutrition knowledge

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

Nutrition knowledge

Intervention Type: BEHAVIORAL

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

Interventions

Nutrition knowledge

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jonathan Sinclair

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Sinclair

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Central Lancashire

Preston, Lancashire, United Kingdom

Countries

United Kingdom

Other Identifiers

Nutrition Education

Identifier Type: -

Identifier Source: org_study_id