Sleep, Lifestyle, Energy, Eating, Exercise Program for the management of sleep apnea patients indicated for weight loss treatment: A randomised, controlled pilot study.

There are two arms to the trial however all participants will precede random allocation with a 2 month very low energy diet (optifast- consisting of one month of 3 shakes per day followed by 2 weeks of 2 shakes per day + food followed by 2 weeks of 1 shake per day + food. AT two months they will be randomised to one of two diets- a low glycemic index/high protein diet or a standard hypocaloric diet. All patients will receive identical lifestyle modification advice and the same model and volume of self directed exercise will be prescribed for all participants. More information regarding the interventions is outlines below. This is a parallel study design which means once a patient has been randomly allocated to their intervention groups they will not crossover to the other intervention program. Very low energy diets are frequently used as an efficient and rapid means of controlled weight loss prior to patients transitioning to a maintenance diet. There is a strong body of evidence using VLED in overweight/obese sleep apnea patients as a precursor to other treatment options. The VLED program structure has been provided by RPAH Metabolism and Obesity Services and has been utilised in clinical services and other research trials frequently in the past. The state of ketosis is achieved as large amounts of fatty acids are broken down in response to extreme energy restriction. VLEDs also contain the recommended daily requirements for vitamins, minerals, trace elements, fatty acids and protein. Those patients achieving desired body weight prior to completion of the 3 month shake period will be reviewed by the study physician and supervising nutritional staff to determine whether to graduate them to a maintenance diet earlier than projected. The specific VLED program can be found in the standard operating procedures manual. Patients will follow a full VLED program for an 8 week period (3 shakes per day) then an initial transition phase for 2 weeks (2 shakes, one meal) followed by a latter transition phase (1 shake, 2 meals) before initiating their randomised maintenance diet. Shakes will be made up to 240 mL using water, each sachet is 40 g and is equivalent to 635 kJ. At baseline patients will see an exercise physiologis/nutritionist for approximately 1.5 hours for individual assessment and introduction to the very low energy diet. Participants will then receive a phone call or skype session at 1 week and 2 weeks to follow up progress with the very low energy diet and allow the opportunity to ask questions. At one month participants will be scheduled to attend the clinic for a routine blood test, safety measures and anthropometry measurements. They will also receive an individual lifestyle modification session focused on exercise. Exercise will be "self managed" throughout the trial however patients will be provided a structured program based on their individual requirements and comorbidities that is focussed on establishing 30 minutes of exercise daily with 2 strength training sessions per week as recommended for the Australian population before progressing to 45-60 minutes of exercise daily (cardio) with 2 strength sessions per week as recommended for clinically significant weight loss. This will be standardised for all participants and a home based strength training program is provided along with clear instructions and demonstrations in clinic. The home based program consists of body weight based exercises such as push ups, participants however will have the option of attending a gym if this is their preference. This is beyond the delivery of the trial however appropriate exercises will be recommended should a participant choose to exercise in this environment. Once the participant reaches their ideal weight their exercise prescription will revert to the 30 minutes daily cardio exercise plus 2 days strength training as recommended for the adult population for the maintenance of weight and health. This is a lifelong recommendation. Participants will then attend the clinic at 2 months for an overnight stay where all outcomes are measured. It is at this point that patients are randomised to a low glycemic index/high protein diet or a standard hypocaloric diet. Participants will also receive dietary counselling regarding the transition from a very low calorie diet to their appropriate dietary group. Calculations will be performed based on the participants current age, height, weight and activity level to determine the calorie intake required to maintain their weight loss. Diet plans have been designed in a unit model whereby filling the units will ensure the various energy requirements/intake is met. Diet plans are equivalent to 5,7,9 and 11 megajoules as required by each individual. DIETARY GROUP DESCRIPTION: LOW GLYCEMIC INDEX/HIGH PROTEIN DIET Participants in this group will be coached to adopt a high protein/low GI weight loss diet based on a 500 calorie restriction (as determined by Harris Benedict Equation). The goal of the diet is to maintain a minimum of 5-10 % weight loss over a 12 month period with sustainable changes in eating patterns. The target macronutrient contribution is 45% of energy from carbohydrates, emphasising low glycaemic sources, 30% from fat and 25% from protein. This macronutrient distribution is similar to the Australian average diet but the GI is lower. The diet will aim to be as low in GI as practical as achieved by replacing higher GI carbohydrates (e.g. conventional white bread, breakfast cereals and potatoes) with lower GI carbohydrates (e.g. Burgen (Registered Trademark) grain breads, oats, pasta, basmati rice). The GI of the low GI/GL diet will be less than 50 (glucose is equivalent to 100) and calculated using published data for Australian foods. The diet will emphasise lean sources of protein and restriction of saturated and transfats (but not total fat). Participants will be provided with The Shoppers Guide to Low GI that outline the carbohydrate choices and the food amounts that constitute one serving. They will also be provided information on the whole diet to ensure energy and overall nutrient balance. Both diets incorporate all food groups (including cereals, grains, pastas, breads, dairy products, meats and other proteins, fish and seafood, fruit, vegetables and healthy fats and occasional foods. They are healthy sustainable diets. The dietary intervention will finish at 6 months however patients are encouraged to maintain their weight loss by permanently following their dietary pattern. Each diet promotes a lifelong way of healthy eating that is indicated for health benefits unless development of a specific medical condition later in life (such as liver disease or kidney failure- not related to these diets) warrants future dietetics assessment and recommendations The lifestyle modification sessions continue with a 3 month phone or skype session, a 4.5 month phonecall or skype session and a 6 month overnight stay where all outcomes are measured. The lifestyle modification sessions entail dietary and exercise advice as described as well as health coaching and the use of appropriate tools to aid behaviour change. This incorporates action planning, the recognition and management of lapses and relapses and long term goal setting. Patients presenting with low adherence to dietary program or demonstrating a need for additional support via more frequent anthropometry may be offered to participate in face to face sessions instead of skype/phonecall sessions. This will be at the discretion of the study physicians and study coordinator where a consensus must be met based on weight loss and patient compliance monitoring. At 6 months the active intervention ceases and patients are encouraged to maintain their weight and health for the following 6 months where they will receive a follow up phonecall at 9 months and a final overnight stay at 12 months to assess all outcomes.