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Trial registered on ANZCTR


Registration number
ACTRN12616000754448
Ethics application status
Approved
Date submitted
23/05/2016
Date registered
8/06/2016
Date last updated
8/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study evaluating the efficacy of a very low energy diet (VLED) for treating obesity in obese older rehabilitation inpatients
Scientific title
Does inpatient weight loss using a very low energy diet (VLED) improve rehabilitation outcome in older, obese inpatients? A pilot study
Secondary ID [1] 289269 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 298852 0
Condition category
Condition code
Diet and Nutrition 298923 298923 0 0
Obesity
Physical Medicine / Rehabilitation 298924 298924 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294820 0
Treatment: Other
Comparator / control treatment
General Healthy eating advice according to the Australian Guide to Healthy Eating in addition to usual rehabilitation care. The dietitian will review each participant, face to face, for approximately 30 minutes, and give the participant a pamphlet on the Australian Guide to Healthy Eating, at randomisation and on discharge from the ward.
Control group
Active

Outcomes
Primary outcome [1] 298387 0
Gait speed on 6 metre walk test
Timepoint [1] 298387 0
0 weeks (randomisation) and 12 weeks post randomisation to diet (VLED/healthy eating)
Secondary outcome [1] 323999 0
Physical function, assessed using the timed up and go test
Timepoint [1] 323999 0
0 weeks (randomisation_ and 12 weeks post randomisation to diet (VLED/healthy eating)
Secondary outcome [2] 324000 0
Instrumental activities of daily living, with reference to the two weeks prior to admission and at 12 weeks, using the Lawton IADL (instrumental activities of daily living) questionnaire.
Timepoint [2] 324000 0
0 weeks (randomisation, with reference to the two weeks prior to admission to hospital) and 12 weeks post randomisation to diet (VLED/healthy eating)
Secondary outcome [3] 324001 0
Quality of life (SF-36)
Timepoint [3] 324001 0
0 weeks and 12 weeks post randomisation to diet (VLED/Healthy eating)
Secondary outcome [4] 324002 0
Functional Independence Measure
Timepoint [4] 324002 0
0 weeks (randomisation), discharge from rehab and 12 weeks post randomisation to diet (VLED/Healthy Eating)

Eligibility
Key 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).
Minimum age
50 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation table kept by person unrelated to study and not shown to study investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
2 (VLED):1 (healthy eating) block randomisation according to BMI (40-49.9 and 50-60) and presence of diabetes
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Pilot study - T test/Mann Whitney U to compare 2 groups

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5831 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 5832 0
Royal Talbot Rehabilitation Centre - Kew

Funding & Sponsors
Funding source category [1] 293651 0
Charities/Societies/Foundations
Name [1] 293651 0
Austin Health Medical Research Foundation
Address [1] 293651 0
Austin Health Medical Research Foundation
c/o Austin Hospital
PO Box 5555
Heidelberg Vic 3084
Australia
Country [1] 293651 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Hospital
PO Box 5555
Heidelberg Vic 3084
Australia
Country
Australia
Secondary sponsor category [1] 292487 0
None
Name [1] 292487 0
nil
Address [1] 292487 0
nil
Country [1] 292487 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295089 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 295089 0
Austin Hospital
PO Box 5555
Heidelberg Vic 3084
Australia
Ethics committee country [1] 295089 0
Australia
Date submitted for ethics approval [1] 295089 0
03/03/2016
Approval date [1] 295089 0
21/04/2016
Ethics approval number [1] 295089 0
HREC/16/Austin/82

Summary
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.
Trial website
none
Trial related presentations / publications
none as yet
Public notes

Contacts
Principal investigator
Name 66074 0
Dr Cilla Haywood
Address 66074 0
Room 109 Boronia Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights Vic 3081
Country 66074 0
Australia
Phone 66074 0
+61394962879
Fax 66074 0
+61394974554
Email 66074 0
chaywood@unimelb.edu.au
Contact person for public queries
Name 66075 0
Dr Cilla Haywood
Address 66075 0
Room 109 Boronia Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights Vic 3081
Country 66075 0
Australia
Phone 66075 0
+61349462879
Fax 66075 0
+61394974554
Email 66075 0
chaywood@unimelb.edu.au
Contact person for scientific queries
Name 66076 0
Dr Cilla Haywood
Address 66076 0
Room 109 Boronia Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights Vic 3081
Country 66076 0
Australia
Phone 66076 0
+61394962879
Fax 66076 0
+61394974554
Email 66076 0
chaywood@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
No Results