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Completed

NCT Number: NCT05198024

Nutrition Education in Cardiac Rehabilitation

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.

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Key information

Conditions

Cardiometabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Nutrition knowledge

Behavioral

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

Primary outcomes

  1. Blood pressure

    Time frame: Baseline

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

  2. Blood pressure

    Time frame: 6-weeks

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

  3. Blood pressure

    Time frame: 12-weeks

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

  4. Waist to hip ratio

    Time frame: Baseline

    Ratio of waist to hip circumference - measured using anthropocentric tape

  5. Waist to hip ratio

    Time frame: 6-weeks

    Ratio of waist to hip circumference - measured using anthropocentric tape

  6. Waist to hip ratio

    Time frame: 12-weeks

    Ratio of waist to hip circumference - measured using anthropocentric tape

  7. Blood glucose

    Time frame: Baseline

    Capillary blood glucose - mmol/L

  8. Blood glucose

    Time frame: 6-weeks

    Capillary blood glucose - mmol/L

  9. Blood glucose

    Time frame: 12-weeks

    Capillary blood glucose - mmol/L

  10. Blood triglycerides

    Time frame: Baseline

    Capillary blood triglycerides - mmol/L

  11. Blood triglycerides

    Time frame: 6-weeks

    Capillary blood triglycerides - mmol/L

  12. Blood triglycerides

    Time frame: 12-weeks

    Capillary blood triglycerides - mmol/L

  13. Blood cholesterol

    Time frame: Baseline

    Capillary blood cholesterol - mmol/L

  14. Blood cholesterol

    Time frame: 6-weeks

    Capillary blood cholesterol - mmol/L

  15. Blood cholesterol

    Time frame: 12-weeks

    Capillary blood cholesterol - mmol/L

  16. Body mass

    Time frame: Baseline

    Body mass (kg)

  17. Body mass

    Time frame: 6-weeks

    Body mass (kg)

  18. Body mass

    Time frame: 12-weeks

    Body mass (kg)

  19. Body mass index

    Time frame: Baseline

    Body mass index kg/m2

  20. Body mass index

    Time frame: 6-weeks

    Body mass index kg/m2

  21. Body mass index

    Time frame: 12-weeks

    Body mass index kg/m2

  22. Waist circumference

    Time frame: Baseline

    Waist circumference (cm)

  23. Waist circumference

    Time frame: 6-weeks

    Waist circumference (cm)

  24. Waist circumference

    Time frame: 12-weeks

    Waist circumference (cm)

  25. Mediterranean Diet score

    Time frame: Baseline

    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.

  26. Mediterranean Diet score

    Time frame: 6-weeks

    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.

  27. Mediterranean Diet score

    Time frame: 12-weeks

    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.

  28. Total energy

    Time frame: Baseline

    Total daily energy (kcal) taken from a 4-day diet diary

  29. Total energy

    Time frame: 6-weeks

    Total daily energy (kcal) taken from a 4-day diet diary

  30. Total energy

    Time frame: 12-weeks

    Total daily energy (kcal) taken from a 4-day diet diary

  31. Calcium intake

    Time frame: Baseline

    Calcium intake per day (mg/day) taken from a 4-day diet diary

  32. Calcium intake

    Time frame: 6-weeks

    Calcium intake per day (mg/day) taken from a 4-day diet diary

  33. Calcium intake

    Time frame: 12-weeks

    Calcium intake per day (mg/day) taken from a 4-day diet diary

  34. Vitamin B12 intake

    Time frame: Baseline

    Vitamin B12 (ug) intake per day taken from a 4-day diet diary

  35. Vitamin B12 intake

    Time frame: 6-weeks

    Vitamin B12 (ug) intake per day taken from a 4-day diet diary

  36. Vitamin B12 intake

    Time frame: 12-weeks

    Vitamin B12 (ug) intake per day taken from a 4-day diet diary

  37. Vitamin B6 intake

    Time frame: Baseline

    Vitamin B6 (mg) intake per day taken from a 4-day diet diary

  38. Vitamin B6 intake

    Time frame: 6-weeks

    Vitamin B6 (mg) intake per day taken from a 4-day diet diary

  39. Vitamin B6 intake

    Time frame: 12-weeks

    Vitamin B6 (mg) intake per day taken from a 4-day diet diary

  40. Folate intake

    Time frame: Baseline

    Folate (ug) intake per day taken from a 4-day diet diary

  41. Folate intake

    Time frame: 6-weeks

    Folate (ug) intake per day taken from a 4-day diet diary

  42. Folate intake

    Time frame: 12-weeks

    Folate (ug) intake per day taken from a 4-day diet diary

  43. Vitamin A intake

    Time frame: Baseline

    Vitamin A (ug) intake per day taken from a 4-day diet diary

  44. Vitamin A intake

    Time frame: 6-weeks

    Vitamin A (ug) intake per day taken from a 4-day diet diary

  45. Vitamin A intake

    Time frame: 12-weeks

    Vitamin A (ug) intake per day taken from a 4-day diet diary

  46. Vitamin C intake

    Time frame: Baseline

    Vitamin C (mg) intake per day taken from a 4-day diet diary

  47. Vitamin C intake

    Time frame: 6-weeks

    Vitamin C (mg) intake per day taken from a 4-day diet diary

  48. Vitamin C intake

    Time frame: 12-weeks

    Vitamin C (mg) intake per day taken from a 4-day diet diary

  49. Vitamin D intake

    Time frame: Baseline

    Vitamin D (ug) intake per day taken from a 4-day diet diary

  50. Vitamin D intake

    Time frame: 6-weeks

    Vitamin D (ug) intake per day taken from a 4-day diet diary

  51. Vitamin D intake

    Time frame: 12-weeks

    Vitamin D (ug) intake per day taken from a 4-day diet diary

  52. Vitamin E intake

    Time frame: Baseline

    Vitamin E (mg) intake per day taken from a 4-day diet diary

  53. Vitamin E intake

    Time frame: 6-weeks

    Vitamin E (mg) intake per day taken from a 4-day diet diary

  54. Vitamin E intake

    Time frame: 12-weeks

    Vitamin E (mg) intake per day taken from a 4-day diet diary

  55. Thiamine intake

    Time frame: Baseline

    Thiamine (mg) intake per day taken from a 4-day diet diary

  56. Thiamine intake

    Time frame: 6-weeks

    Thiamine (mg) intake per day taken from a 4-day diet diary

  57. Thiamine intake

    Time frame: 12-weeks

    Thiamine (mg) intake per day taken from a 4-day diet diary

  58. Riboflavin intake

    Time frame: Baseline

    Riboflavin (mg) intake per day taken from a 4-day diet diary

  59. Riboflavin intake

    Time frame: 6-weeks

    Riboflavin (mg) intake per day taken from a 4-day diet diary

  60. Riboflavin intake

    Time frame: 12-weeks

    Riboflavin (mg) intake per day taken from a 4-day diet diary

  61. Selenium intake

    Time frame: Baseline

    Selenium (ug) intake per day taken from a 4-day diet diary

  62. Selenium intake

    Time frame: 6-weeks

    Selenium (ug) intake per day taken from a 4-day diet diary

  63. Selenium intake

    Time frame: 12-weeks

    Selenium (ug) intake per day taken from a 4-day diet diary

  64. Zinc intake

    Time frame: Baseline

    Zinc (mg) intake per day taken from a 4-day diet diary

  65. Zinc intake

    Time frame: 6-weeks

    Zinc (mg) intake per day taken from a 4-day diet diary

  66. Zinc intake

    Time frame: 12-weeks

    Zinc (mg) intake per day taken from a 4-day diet diary

  67. Sodium intake

    Time frame: Baseline

    Sodium (mg) intake per day taken from a 4-day diet diary

  68. Sodium intake

    Time frame: 6-weeks

    Sodium (mg) intake per day taken from a 4-day diet diary

  69. Sodium intake

    Time frame: 12-weeks

    Sodium (mg) intake per day taken from a 4-day diet diary

  70. Carbohydrate intake

    Time frame: Baseline

    Carbohydrate (g) intake per day taken from a 4-day diet diary

  71. Carbohydrate intake

    Time frame: 6-weeks

    Carbohydrate (g) intake per day taken from a 4-day diet diary

  72. Carbohydrate intake

    Time frame: 12-weeks

    Carbohydrate (g) intake per day taken from a 4-day diet diary

  73. Fat intake

    Time frame: Baseline

    Fat (g) intake per day taken from a 4-day diet diary

  74. Fat intake

    Time frame: 6-weeks

    Fat (g) intake per day taken from a 4-day diet diary

  75. Fat intake

    Time frame: 12-weeks

    Fat (g) intake per day taken from a 4-day diet diary

  76. Sugar intake

    Time frame: Baseline

    Sugar (g) intake per day taken from a 4-day diet diary

  77. Sugar intake

    Time frame: 6-weeks

    Sugar (g) intake per day taken from a 4-day diet diary

  78. Sugar intake

    Time frame: 12-weeks

    Sugar (g) intake per day taken from a 4-day diet diary

  79. Fibre intake

    Time frame: Baseline

    Fibre (g) intake per day taken from a 4-day diet diary

  80. Fibre intake

    Time frame: 6-weeks

    Fibre (g) intake per day taken from a 4-day diet diary

  81. Fibre intake

    Time frame: 12-weeks

    Fibre (g) intake per day taken from a 4-day diet diary

  82. Starch intake

    Time frame: Baseline

    Starch (g) intake per day taken from a 4-day diet diary

  83. Starch intake

    Time frame: 6-weeks

    Starch (g) intake per day taken from a 4-day diet diary

  84. Starch intake

    Time frame: 12-weeks

    Starch (g) intake per day taken from a 4-day diet diary

  85. Protein intake

    Time frame: Baseline

    Protein (g) intake per day taken from a 4-day diet diary

  86. Protein intake

    Time frame: 6-weeks

    Protein (g) intake per day taken from a 4-day diet diary

  87. Protein intake

    Time frame: 12-weeks

    Protein (g) intake per day taken from a 4-day diet diary

  88. Saturated fat intake

    Time frame: Baseline

    Saturated fat (g) intake per day taken from a 4-day diet diary

  89. Saturated fat intake

    Time frame: 6-weeks

    Saturated fat (g) intake per day taken from a 4-day diet diary

  90. Saturated fat intake

    Time frame: 12-weeks

    Saturated fat (g) intake per day taken from a 4-day diet diary

  91. Monounsaturated fat intake

    Time frame: Baseline

    Monounsaturated fat (g) intake per day taken from a 4-day diet diary

  92. Monounsaturated fat intake

    Time frame: 6-weeks

    Monounsaturated fat (g) intake per day taken from a 4-day diet diary

  93. Monounsaturated fat intake

    Time frame: 12-weeks

    Monounsaturated fat (g) intake per day taken from a 4-day diet diary

  94. Polyunsaturated fat intake

    Time frame: Baseline

    Polyunsaturated fat (g) intake per day taken from a 4-day diet diary

  95. Polyunsaturated fat intake

    Time frame: 6-weeks

    Polyunsaturated fat (g) intake per day taken from a 4-day diet diary

  96. Polyunsaturated fat intake

    Time frame: 12-weeks

    Polyunsaturated fat (g) intake per day taken from a 4-day diet diary

Sponsors and collaborators

Lead sponsor

Jonathan Sinclair

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2020
First posted
Jan 20, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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