non-dominant arm to quantify energy expenditure, sleep, body temperature, intensity of physical activity and steps taken. Food and Activity Diary: Minimum 4 day collection period (3 weekdays and 2 weekend days) to assess habitual dietary intake and energy expenditure via the Bouchard Questionnaire. Actiwatch Diary Food Habits Questionnaire (FHQ95): To assess usual eating habits International Physical Activity Questionnaire (IPAQ): To provide health related physical activity data Eating Disorder Examination Questionnaire: (EDE-Q; Fairburn & Cooper, 1993) will be used to assess the specific psychopathology of eating disorders. The EDE-Q is comprised of four subscales: restraint, weight, shape and eating concerns. (VLED): 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 , , , 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.
non-dominant arm to quantify energy expenditure, sleep, body temperature, intensity of physical activity and steps taken. Food and Activity Diary: Minimum 4 day collection period (3 weekdays and 2 weekend days) to assess habitual dietary intake and energy expenditure via the Bouchard Questionnaire. Actiwatch Diary Food Habits Questionnaire (FHQ95): To assess usual eating habits International Physical Activity Questionnaire (IPAQ): To provide health related physical activity data Eating Disorder Examination Questionnaire: (EDE-Q; Fairburn & Cooper, 1993) will be used to assess the specific psychopathology of eating disorders. The EDE-Q is comprised of four subscales: restraint, weight, shape and eating concerns. (VLED): 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 , , , 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.
363680-SLEEEP_Protocol_MasterVersion_3_Clean.docx