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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]

none

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Physical Medicine / Rehabilitation

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]

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]

Gait speed on 6 metre walk test

Timepoint [1]

0 weeks (randomisation) and 12 weeks post randomisation to diet (VLED/healthy eating)

Secondary outcome [1]

Physical function, assessed using the timed up and go test

Timepoint [1]

0 weeks (randomisation_ and 12 weeks post randomisation to diet (VLED/healthy eating)

Secondary outcome [2]

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]

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]

Quality of life (SF-36)

Timepoint [3]

0 weeks and 12 weeks post randomisation to diet (VLED/Healthy eating)

Secondary outcome [4]

Functional Independence Measure

Timepoint [4]

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

Sex

Both males and females

Can healthy volunteers participate?

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

13/06/2016

Actual

Date of last participant enrolment

Anticipated

6/02/2017

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]

Austin Health - Heidelberg Repatriation Hospital - Heidelberg West

Recruitment hospital [2]

Royal Talbot Rehabilitation Centre - Kew

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Austin Health Medical Research Foundation

Address [1]

Austin Health Medical Research Foundation
c/o Austin Hospital
PO Box 5555
Heidelberg Vic 3084
Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Austin Health

Address

Austin Hospital
PO Box 5555
Heidelberg Vic 3084
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

nil

Address [1]

nil

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

Austin Hospital
PO Box 5555
Heidelberg Vic 3084
Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

03/03/2016

Approval date [1]

21/04/2016

Ethics approval number [1]

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

Dr Cilla Haywood

Address

Room 109 Boronia Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights Vic 3081

Country

Australia

Phone

+61394962879

Fax

+61394974554

chaywood@unimelb.edu.au

Contact person for public queries

Name

Cilla Haywood

Address

Room 109 Boronia Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights Vic 3081

Country

Australia

Phone

+61349462879

Fax

+61394974554

chaywood@unimelb.edu.au

Contact person for scientific queries

Name

Cilla Haywood

Address

Room 109 Boronia Building
Heidelberg Repatriation Hospital
300 Waterdale Road
Heidelberg Heights Vic 3081

Country

Australia

Phone

+61394962879

Fax

+61394974554

chaywood@unimelb.edu.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

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No additional documents have been identified.

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