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Trial registered on ANZCTR


Registration number
ACTRN12611000408987
Ethics application status
Approved
Date submitted
18/04/2011
Date registered
19/04/2011
Date last updated
28/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Obesity in older adults: effect of exercise and weight loss on physiology and function.
Scientific title
In obese older adults, is a very low energy diet (VLED) with exercise, a hypocaloric diet with exercise, or exercise alone best to improve physical function?
Secondary ID [1] 260021 0
Nil
Universal Trial Number (UTN)
U1111-1120-8363
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 265681 0
Condition category
Condition code
Diet and Nutrition 265819 265819 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 1:Very Low Energy Diet (VLED) - Optifast plus exercise
Optifast is a commercially available Very Low Energy diet.
The diet prescribed to the participants will consist of 1 sachet/bar/soup prepared as per directions on box, for each of breakfast and lunch.
Dinner will consist of a serve of lean protein (lean red meat/fish/tofu) plus a serve of non-starchy vegetables plus a teaspoon of oil to contract the gallbladder.
The target energy intake is 800kCal per day and the duration of the intervention is 12 weeks.
Exercise: 3x45 minute sessions per week, for 12 weeks. The program is called "Heartmoves" and was designed by the National Heart Foundation especially for older people. It involves resistance, balance, strength and endurance components. The intensity of the exercise will be guided by the participant as the moves can be modified. The classes will either be delivered by a trained Heartmoves aerobics instructor or the patient can do the exercise at home by watching a DVD. A physiotherapist will be involved in the study to treat/monitor any injuries.
Arm 2: Hypocaloric Diet Plus exercise
Hypocaloric diet: A diet will be prescribed by a dietician tailored to the participant. The diet will contain enough nutrients for the participant but have fewer calories than what they need (approximately 2000kJ/day deficit from basal requirements), which will result in slow weight loss.
The duration of the intervention will be 12 weeks. The participant will have a long (1 hour) consultation at the beginning of the trial and shorter (approx 30 minute) consultations every 2 weeks during the trial).
The exercise component will be Heartmoves as above.
Intervention code [1] 264441 0
Treatment: Other
Intervention code [2] 264442 0
Behaviour
Comparator / control treatment
Arm 3: Exercise alone - Heartmoves as above
Control group
Active

Outcomes
Primary outcome [1] 266574 0
Physical function -
The De Morton Mobility Index (DEMMI) will be used. This is a test of 19 items, from the very basic (bridging in bed) to more advanced (jumping, picking up a pen from the floor). This index is validated in community dwelling older adults.
Other tests of physical function will be the 6 minute walk test and a questionnaire called the human activity profile, which gives a more qualitative account of what the participant can do (eg. walk on uneven ground, walk up steps etc)
Timepoint [1] 266574 0
0 and 12 weeks
Secondary outcome [1] 276041 0
Cognition - via the Victoria Stroop Interference test, Controlled Oral Word Association Test and Trail Making Tests A and B. These tests are responsive to changes in diet and take about 15 minutes to administer.
We will also be measuring serum ketones at this time
Timepoint [1] 276041 0
0, 2, 12 and 14 weeks
Secondary outcome [2] 276042 0
Serum Cholesterol and Blood Glucose
Timepoint [2] 276042 0
0 and 12 weeks
Secondary outcome [3] 276043 0
Blood pressure - supine resting blood pressure measured using a manual sphygmomanometer
Timepoint [3] 276043 0
0, 2,4,6,8,10, 12 and 14 weeks
Secondary outcome [4] 276044 0
Quality of life - the AQoL 8d questionnaire will be used.
Timepoint [4] 276044 0
0 and 12 weeks
Secondary outcome [5] 301745 0
6 minute walk test distance
Timepoint [5] 301745 0
0 and 12 weeks
Secondary outcome [6] 301746 0
Serum inflammatory markers
Timepoint [6] 301746 0
0 and 12 weeks
Secondary outcome [7] 307580 0
Body Composition Via Dual Energy XRay Absorptiometry (DEXA)
Timepoint [7] 307580 0
0 and 12 weeks

Eligibility
Key inclusion criteria
Age over 65 Body Mass index over 35 One or more complications of obesity - hypertension, obstructive sleep apnoea, osteoarthritis, type 2 diabetes, Living in community (including retirement village)
Minimum age
65 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Living in residential care (hostel or nursing home) Unstable disease state (symptomatic cardiorespiratory disease, brittle diabetes etc) Diseases with a prognosis of less than five years Diseases which have an effect on weight (eg uncontrolled thyroid disease)

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)
patient enrolled by study doctor. Patients randomised to treatment. Randomisation form kept by person independent to study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Statistician created block randomisation model stratified for gender and diabetic status
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
14/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 772 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 773 0
The Northern Hospital - Epping
Recruitment postcode(s) [1] 6584 0
3081 - Heidelberg Heights
Recruitment postcode(s) [2] 6585 0
3076 - Epping

Funding & Sponsors
Funding source category [1] 264910 0
Government body
Name [1] 264910 0
National Health and Medical Research Council
Country [1] 264910 0
Australia
Funding source category [2] 286899 0
Charities/Societies/Foundations
Name [2] 286899 0
Diabetes Australia Research trust
Country [2] 286899 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Repatriation Campus
Waterdale Road, Heidelberg Heights
Victoria 3084
Country
Australia
Secondary sponsor category [1] 264011 0
University
Name [1] 264011 0
University of Melbourne
Address [1] 264011 0
Austin Health Department of Medicine
University of Melbourne
Repatriation Campus
Waterdale Road, Heidelberg Heights
Victoria 3084
Country [1] 264011 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266869 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 266869 0
Ethics committee country [1] 266869 0
Australia
Date submitted for ethics approval [1] 266869 0
05/04/2011
Approval date [1] 266869 0
03/08/2011
Ethics approval number [1] 266869 0
04274
Ethics committee name [2] 288959 0
Northern Health Human Research Ethics Committee
Ethics committee address [2] 288959 0
Ethics committee country [2] 288959 0
Date submitted for ethics approval [2] 288959 0
11/12/2012
Approval date [2] 288959 0
05/02/2013
Ethics approval number [2] 288959 0
P19/12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32507 0
Prof Joe Proietto
Address 32507 0
2nd Floor
Boronia Building
Heidelberg Repatriation Hospital
Waterdale Rd
Heidelberg Heights Vic 3081
Country 32507 0
Australia
Phone 32507 0
+61394962160
Fax 32507 0
+61394974554
Email 32507 0
[email protected]
Contact person for public queries
Name 15754 0
Cilla Haywood
Address 15754 0
Department of Medicine University of Melbourne
Repatriation Campus, Austin Health
300 Waterdale Rd Heidelberg Heights
Victoria 3084
Country 15754 0
Australia
Phone 15754 0
+61394962879
Fax 15754 0
+61394974554
Email 15754 0
[email protected]
Contact person for scientific queries
Name 6682 0
Joe Proietto
Address 6682 0
Department of Medicine University of Melbourne
Repatriation Campus, Austin Health
300 Waterdale Rd Heidelberg Heights
Victoria 3084
Country 6682 0
Australia
Phone 6682 0
+61394962250
Fax 6682 0
+61394974554
Email 6682 0
[email protected]

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

Documents added manually
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Documents added automatically
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