A randomised controlled trial to evaluate an intensive lifestyle program for reversal of coronary heart disease.

Intensive lifestyle program (ILP) + Optimal medical therapy (OMT). Participants in this group will receive OMT, which refers to continued communication and reviews from their cardiologist who will adjust medications as required over the course of the study. They will also receive IMT which involves 1 year of a 5:2 pesco-vegetarian diet, physical activity and mindfulness training. Participants will be educated, instructed, and monitored through a phone-app. Participants will have regular face-to-face or Zoom call contact with study a dietician, exercise physiologist, and a mindfulness coach who will monitor their progress through the app. Details of each aspect can be seen below: 5:2 PESCO-VEGETARIAN DIET: Participants will be provided with food from Marley Spoon, who will deliver freshly made meals for the first 4 weeks of the intervention. They will also work alongside the study dietitian to design their weekly meal plans and menus in order to transition into making their own food after the first 4 weeks. The aim will be to substitute meat with fish and processed and refined foods with a range of minimally processed plant-based foods. Individuals will be asked to fast on 2 non-consecutive days of the week, allowing 2 vegetable meals of around 2000 kJ per day for women and about 2500 kJ for men. Participants will meet with the study dietician in person for an initial appointment at baseline. They will then be offered zoom or face-to-face meetings (30-45mins) bi-weekly for the first 3 months and monthly thereafter. Strategies to implement the dietary changes, meal planning, healthy recipes and nutritional information will be covered during dietician appointments. Body weight will be monitored weekly to help assess if participants are compliant with the dietary intervention. Study volunteers will report their body weights to the dietitian on a weekly basis using the LIVEPLUS app. PHYSICAL ACTIVITY: Participants will be given an individualised home-based programme which will be based on the following guidelines from the American College of Cardiology Foundation/American Heart Association to manage individuals with stable ischemic heart disease. We will individualise each participant’s home-based physical activity programme according to their baseline activity. To measure baseline activity, participants will wear a Fitbit physical activity tracker for 7 continuous days and will complete a PAR questionnaire. They will then receive an initial consultation with an exercise physiologist who will set up a personalised programme. The goal for all participants will be to reach at least 150 minutes of moderate-intensity aerobic physical activity per week within the first 3 months. Intensity will be prescribed and monitored using the Fitbit heart rate zones, using 220-age as a prediction of maximal heart rate. During the first 3 months, participants will have bi-weekly 30 min appointments via zoom or face-to-face with their exercise physiologist. If participants are asymptomatic during the first 3 months of physical activity intervention, the following 9 months (month 3-12) will aim to vary the prescription in terms of mode, duration and intensity. Participants will be offered monthly 30 minute sessions during these months which will be an opportunity for their physical activity coach to prescribe variations in their training. Symptomatic participants will follow the same prescription until symptoms abate with ongoing monthly review. The specific symptoms monitored will be hear rate response during physical activity (from Fitbit), and then subjective feelings from participants which include; chest pain, dizziness or light-headedness, shortness of breath, nausea. MINDFULNESS: Mindfulness-Based Stress Reduction (MBSR) is a specific approach that integrates meditation and gentle hatha yoga and has been studied both clinically and using systematic reviews. MBSR has been shown to be an effective and safe means for reducing stress. We plan to implement this program over the course of our study, using the structure and content from the online free course https://palousemindfulness.com. Each session will be conducted one-on-one to foster an ongoing, attentive relationship with each participant. The first session will be conducted in person to establish a comfortable rapport, and the following 14 sessions will be conducted electronically to decrease study burden to participants. The purpose of the first session will be to introduce to the participants the physiological relationship between heart disease and mental heath, as well as the science behind how mindfulness helps to improve this relationship. We also will explain what mindfulness and mindfulness-based stress reduction are and provide an outline of the intervention they will receive over the course of one year. Over the following sessions, participants will receive training mindfulness, such as practices like the body scan, breathing exercises, such as slow breathing at 6 breaths/minute and diaphragmatic breathing, education in posture for seated meditation and gentle yoga, and classic gentle yoga poses. The mode of training will primarily be delivered through the study app and consist of modules with new mindfulness information for each month in text form, multiple choice questions to verify understanding, short videos that explain different techniques, and a log to record breathing exercises and mindfulness practice for each month. Discussions with the mindfulness coach over zoom to answer any questions also will be used. Various educational materials will be given to participants. Palouse guidelines will be incorporated. However, the Palouse course is designed for 8 weeks. Because this study will be for one year, we will add educational materials to each month to supplement to Palouse course. For example, we will supplement each month with breathing exercises that have been researched by Dr. Richard Brown, such as slow and diaphragmatic breathing, as well as with mindfulness and breathing techniques described by Goswami Kriyananda from the Temple of Kriya Yoga in Chicago. Education on the science behind self-compassion, social connectedness, happiness, and interpersonal relationships will be informed by the scientific literature. One module will be released to participants through the study app each month and will take about 30 minutes to complete. In addition to reading this educational content, the mindfulness component of the intervention will consist of about 10 minutes of breathing exercise 6 days/week and 20 minutes of mindfulness practice (e.g., body scan, gentle yoga, mantra) 3 days/week. Participants also will meet with the mindfulness coach over zoom once a month for open ended discussion about the educational content and practice for 5-30 minutes, depending on participant preferences on duration of the call