NCT05198024

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

December 16, 2021

Last Update Submit

November 8, 2023

Conditions

Cardiometabolic Syndrome

Outcome Measures

Primary Outcomes (96)

  • Blood pressure

    Systolic and diastolic blood pressure - measured using a digital blood pressure monitor

    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

    Baseline

  • 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

    Baseline

  • 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

    Baseline

  • Blood triglycerides

    Capillary blood triglycerides - mmol/L

    6-weeks

  • Blood triglycerides

    Capillary blood triglycerides - mmol/L

    12-weeks

  • Blood cholesterol

    Capillary blood cholesterol - mmol/L

    Baseline

  • Blood cholesterol

    Capillary blood cholesterol - mmol/L

    6-weeks

  • Blood cholesterol

    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)

    Baseline

  • 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

Study Arms (3)

Usual care

PLACEBO COMPARATOR

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

Usual care plus biggest loser

EXPERIMENTAL

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

Usual care plus new education programme

EXPERIMENTAL

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

Interventions

Nutrition knowledgeBEHAVIORAL

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

Usual careUsual care plus biggest loserUsual care plus new education programme

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Clinically Unstable (symptoms and medication)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

Location

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 20, 2022

Study Start

January 1, 2018

Primary Completion

September 1, 2018

Study Completion

January 1, 2020

Last Updated

November 13, 2023

Record last verified: 2023-11

Locations

GB(1)