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Trial registered on ANZCTR


Registration number
ACTRN12610000819022
Ethics application status
Approved
Date submitted
29/09/2010
Date registered
30/09/2010
Date last updated
26/11/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Malnutrition in Parkinson's disease and an individualised approach to its management
Scientific title
Malnutrition in Parkinson's disease and an individualised approach to its management
Secondary ID [1] 252789 0
nil
Universal Trial Number (UTN)
U1111-1117-2697
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's disease 258290 0
Condition category
Condition code
Neurological 258485 258485 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The 12 week intervention will consist of individualised dietetic advice regarding ways to ensure adequate energy and protein intake to improve nutritional status. This information will be provided at baseline by a dietitian. Fortnightly phone calls consisting of a 24 hour diet history will be conducted by a dietitian to ensure compliance, modify the diet as necessary and to answer any questions that the participant may have. These phone calls are expected to last from 30 minutes to 1 hour. 3 day food diaries will be collected at baseline and also the week before the visit at Week 6 and before the visit at Week 12 during the intervention period.
Intervention code [1] 257316 0
Other interventions
Comparator / control treatment
The control group of people with Parkinson's disease will be asked to fill out a 3 day food diary at baseline and also the week before the visit at Week 6 and before the visit at Week 12 during the intervention period. Fortnightly phone calls consisting of a 24 hour diet history will be conducted by a dietitian.
Control group
Active

Outcomes
Primary outcome [1] 259320 0
Nutritional status using 4 compartment body composition analysis, the Patient-Generated Subjective Global Assessment (PG-SGA), weight, Body Mass Index (BMI)
Timepoint [1] 259320 0
Baseline, + 6 weeks, + 12 weeks for intervention and control groups
Primary outcome [2] 259321 0
Motor symptoms using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III, objective tremor assessment, objective balance assessment, Timed Up and Go (TUG)
Timepoint [2] 259321 0
Baseline, + 6 weeks, + 12 weeks for intervention and control groups
Primary outcome [3] 259322 0
Non-motor symptoms using the Non-Motor Symptom Scale (NMSS)
Timepoint [3] 259322 0
Baseline, + 6 weeks, + 12 weeks for intervention and control groups
Secondary outcome [1] 265768 0
Quality of life using the Parkinson's disease questionnaire (PDQ-39)
Timepoint [1] 265768 0
Baseline, + 6 weeks, + 12 weeks for intervention and control groups

Eligibility
Key inclusion criteria
Diagnosis of idiopathic Parkinson's disease and categorisation of SGA 'B' or 'C' using the PG-SGA
Minimum age
18 Years
Maximum age
100 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous surgical therapy, such as deep brain stimulation or scheduled for deep brain stimulation surgery during time of the study

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator was used to assign each ID to a group (intervention or control).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)

Funding & Sponsors
Funding source category [1] 257743 0
Charities/Societies/Foundations
Name [1] 257743 0
Parkinson's Queensland, Inc.
Address [1] 257743 0
Unit 2/25 Watland Street, Springwood, QLD 4127
Country [1] 257743 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
Victoria Park Road
Kelvin Grove, QLD 4059
Country
Australia
Secondary sponsor category [1] 256957 0
None
Name [1] 256957 0
Address [1] 256957 0
Country [1] 256957 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259798 0
Queensland University of Technology Human Research Ethics Committee
Ethics committee address [1] 259798 0
Victoria Park Road Kelvin Grove, QLD 4059
Ethics committee country [1] 259798 0
Australia
Date submitted for ethics approval [1] 259798 0
10/10/2010
Approval date [1] 259798 0
11/01/2011
Ethics approval number [1] 259798 0
1000001150

Summary
Brief summary
Malnutrition, especially unintentional weight loss, is a known issue in Parkinson's disease. Malnutrition is associated with a number of adverse outcomes including decreased physical function, higher mortality, impaired immunity, longer hospital stays and decreased quality of life. People with Parkinson's disease are at a higher risk of malnutrition due to the motor and non-motor symptoms associated with the disease as well as the side effects of anti-parkinsonian medication. To date, an intervention to address malnutrition in this population has not been conducted.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31716 0
Address 31716 0
Country 31716 0
Phone 31716 0
Fax 31716 0
Email 31716 0
Contact person for public queries
Name 14963 0
Jamie Sheard
Address 14963 0
Queensland University of Technology
Institute of Health and Biomedical Innovation
60 Musk Ave
Kelvin Grove, QLD 4059
Country 14963 0
Australia
Phone 14963 0
+61731386183
Fax 14963 0
Email 14963 0
jamie.sheard@qut.edu.au
Contact person for scientific queries
Name 5891 0
Jamie Sheard
Address 5891 0
Queensland University of Technology
Institute of Health and Biomedical Innovation
60 Musk Ave
Kelvin Grove, QLD 4059
Country 5891 0
Australia
Phone 5891 0
+61731386183
Fax 5891 0
Email 5891 0
jamie.sheard@qut.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary