None listed
Conditions
Brief summary
Obesity is common in older persons and predisposes to physical disability and loss of independence. After a hospitalisation for an illness or surgery, older people may have to go to a rehabilitation ward to get back to their previous abilities in their home and environment (ie their physical function), to be able to do everything they could do previously. Older people who carry a lot of extra weight may be at increased risk than others in the same age group of not being able to get back to their previous abilities after going to hospital, or it may take longer for them to get back to their previous state. Recent research has found that rapid, significant weight loss achieved with Very Low Energy Diets (VLEDs) were safe and effective in improving physical function. This treatment may be useful for improving the function of older, obese people who are on the rehabilitation ward, but we have not tested weight loss with a VLED in this situation. We would like to see whether it is possible to get people to start a weight loss program while a rehabilitation inpatient, and continue it for 12 weeks, even if they go home during that period. We would like to see which approach leads to better and/or faster improvements in physical function; usual rehabilitation care plus general healthy eating advice (ie the care people receive now) or usual rehabilitation care plus weight loss with a VLED. We will offer certain patients aged between 50 and 80 years of age who have a BMI between 40 and 60 the opportunity to join this study, the doctor on the ward will assess whether the study is suitable for the particular patient. Patients who meet the criteria (the “inclusion criteria”) and agree to be in the study will be randomly allocated to either the VLED group or the healthy eating group in addition to usual rehabilitation care – for every 2 patients allocated to the VLED group, one will be allocated to the healthy eating group.
Interventions
Weight loss using very low energy diet in addition to usual rehabilitation care.
The very low energy diet will consist of replacement of breakfast and lunch with a VLED preparation (Optifast R-260kCal per replacment, nutritionally complete).
Dinner will either be a third VLED preparation, or a low carbohydrate meal, based on participant preference or rate of weight loss (if weight loss slow, recommend replacement of all meals).
Participants with a body mass index (BMI) of 50-60 will have an e
Weight loss using very low energy diet in addition to usual rehabilitation care. The very low energy diet will consist of replacement of breakfast and lunch with a VLED preparation (Optifast R-260kCal per replacment, nutritionally complete). Dinner will either be a third VLED preparation, or a low carbohydrate meal, based on participant preference or rate of weight loss (if weight loss slow, recommend replacement of all meals). Participants with a body mass index (BMI) of 50-60 will have an extra VLED (260kCal) preparation per day, due to increased metabolic rate of this group compared with the 40-50 BMI group. This will be taken at any time during the day, or divided, as desired. This will continue for 12 weeks. Regarding adherence, participants will be encouraged to fill out a food diary.
Sponsors
Austin Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. be aged 50 to 80 years of age, 2. have a Body Mass Index (BMI) between 40 and 60 kg/m2, 3. have a goal agreed between themselves, their family and their GEM/ rehab physician of returning home and walking independently (with or without a gait aid).
Exclusion criteria
There is a history of cognitive impairment (dementia or unresolved delirium) The mobility goals are limited to non-weight bearing mobility goals, or requiring assistance of another person, or requiring a wheelchair. There has been significant (>5kg) weight loss in the year prior to the index admission to hospital
Outcome results
None listed