Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000260426
Ethics application status
Approved
Date submitted
23/02/2016
Date registered
25/02/2016
Date last updated
1/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Determinants of nutritional status among older people living in urban and rural area of Yogyakarta
Scientific title
Physiological and non-physiological factors associated with malnutrition among older people living in urban and rural area of Yogyakarta, Indonesia
Secondary ID [1] 288612 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malnutrition 297760 0
Condition category
Condition code
Diet and Nutrition 297943 297943 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study investigates the prevalence and cause of malnutrition among older people living in urban and rural area of Yogyakarta, Indonesia. Rigorous parameters will be used to determine nutritional status and frailty, ranging from anthropocentric, biochemical, clinical and dietary, and functional assessments. Due to the substantial differences in demographic and socio-economic characteristics between urban and rural area, a structured questionnaire will be used to investigate food security and supply at household levels. Participants were assessed at a single timepoint at enrollment.
Intervention code [1] 294012 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297464 0
Nutritional status as assessed by anthropometry (BMI, Mid-arm Muscle Area/AMA), biochemical (whole blood CBC & Albumin, serum CRP and interleukins i.e IL-1b, IL-6, IL-10,TNFa, IL-4, IFNg), and screening tools (Visual Analogues Scale on Nutritional Status, Geriatric Nutrition Risk Index (GNRI), Mini Nutritional Assessment (MNA), Malnutrition Universal Screening Tool (MUST), Malnutrition Screening Tool (MST), and Short Nutritional Assessment Questionnaire (SNAQ)
Timepoint [1] 297464 0
Baseline
Primary outcome [2] 297465 0
Frailty measured by Fatigue, resistance, aerobic, illness, and loss of weight Scale (FRAIL) and Edmonton Frail Scale (EFS)
Timepoint [2] 297465 0
Baseline
Secondary outcome [1] 321115 0
Physical Activity and muscle function measured by handgrip strength, 3-m walk test, and International Physical Activity Questionnaire (IPAQ) Instrumental Activity Daily of Living (IADL)
Timepoint [1] 321115 0
Baseline
Secondary outcome [2] 321116 0
Mental status measured by Geriatric Depression Scale (GDS), and Mini Mental State Examination scale (MMSE)
Timepoint [2] 321116 0
Baseline
Secondary outcome [3] 321117 0
Food intake and dietary habits measured by validated Semi Quantitative-Food Frequency Questionnaire (SQFFQ) and 24-hour recall
Timepoint [3] 321117 0
Baseline
Secondary outcome [4] 321118 0
Food supply and food security measured by structured questionnaire designed specifically for this study.
Timepoint [4] 321118 0
Baseline
Secondary outcome [5] 321119 0
Hospital admission and length of hospital stay in the past 6 months by self-report from participants
Timepoint [5] 321119 0
Baseline
Secondary outcome [6] 321120 0
Body composition measured by Bioelectrical impedance Analysis (BIA)and Skinfold thickness at 4 points (triceps, biceps, sub-scapula, supra-iliaca)
Timepoint [6] 321120 0
Baseline

Eligibility
Key inclusion criteria
1. Men and women aged 65 years and over
2. Had been living in Yogyakarta for at least 1 year prior to the study.
3. Able to communicate with the investigator and understand the study protocol
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Individuals who have mild to severe dementia (memory function) or are unable to comprehend the study protocol will be excluded.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Sample size was calculated with GPower version 3.1.9.2 (Universitat Kiel, Germany). With 95% power, 5% error and inclusion of up to 15 different variables into the regression model, the study requires a minimum sample size of 262 subjects (from both the urban and rural regions) to detect an effect size of 0.05. The details of sample size calculation (GPower output) are as follow:

Linear multiple regression: Fixed model, single regression coefficient
Analysis: A priori: Compute required sample size
Input: Tail(s) = Two
Effect size f^2 = 0.05
a err prob = 0.05
Power (1-beta err prob) = 0.95
Number of predictors = 15
Output: Noncentrality parameter d = 3.6193922
Critical t = 1.9696542
Df = 246
Total sample size = 262
Actual power = 0.9500422

Statistical Analysis will be performed using SPSS version 22.0 for Windows. Results for all parameters will be presented for all areas (total) as well as breakdown by sub-districts and villages. All analyses will be performed according to the intention-to-treat principle controlling for the effects of recruitment area. Paired t-test will be performed to measure changes in within areas, while independent t-test will be used to determine differences between subject from urban and rural areas. Multivariate analysis using multiple logistic regression will be used to determine the predictors of nutritional status including gender, age, energy and protein intake, nutritional status, weight, BMI, frailty, physical activity and muscle function, mental status, medications, co-morbidities, and socio-economic status.
Meanwhile, Qualitative data will be recorded and transcribed. Then the data will be analyzed according to response/answers, frequency/percentages of each similar response/answers will be calculated and presented in descriptive statistics.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
18/09/2015
Date of last participant enrolment
Anticipated
Actual
13/10/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
262
Accrual to date
Final
525
Recruitment outside Australia
Country [1] 7612 0
Indonesia
State/province [1] 7612 0
Yogyakarta

Funding & Sponsors
Funding source category [1] 292956 0
University
Name [1] 292956 0
Universitas Gadjah Mada
Country [1] 292956 0
Indonesia
Funding source category [2] 292957 0
Charities/Societies/Foundations
Name [2] 292957 0
Commerce International Merchant Bankers Berhad (CIMB) Foundation
Country [2] 292957 0
Malaysia
Funding source category [3] 292958 0
Government body
Name [3] 292958 0
CSIRO
Country [3] 292958 0
Australia
Funding source category [4] 292959 0
Hospital
Name [4] 292959 0
Royal Adelaide Hospital
Country [4] 292959 0
Australia
Primary sponsor type
Individual
Name
Mr Tony Arjuna
Address
Discipline of Medicine, University of Adelaide
Level 6, Eleanor Harrald Building
Frome Road, Adelaide, SA 5005
Country
Australia
Secondary sponsor category [1] 291727 0
Individual
Name [1] 291727 0
Prof Ian Chapman
Address [1] 291727 0
Discipline of Medicine, University of Adelaide
Level 6, Eleanor Harrald Building
Frome Road, Adelaide, SA 5005
Country [1] 291727 0
Australia
Secondary sponsor category [2] 291728 0
Individual
Name [2] 291728 0
Dr Natalie Luscombe-Marsh
Address [2] 291728 0
Level 7, SAHMRI, North Terrace, Adelaide SA 5000
PO Box 10097, Adelaide BC SA 5000
Country [2] 291728 0
Australia
Secondary sponsor category [3] 291729 0
Individual
Name [3] 291729 0
Dr Stijn Soenen
Address [3] 291729 0
Discipline of Medicine, University of Adelaide
Level 3, Eleanor Harrald Building
Frome Road, Adelaide, SA 5005
Country [3] 291729 0
Australia
Secondary sponsor category [4] 291730 0
Individual
Name [4] 291730 0
Ms Rasita Amelia Hasnawati
Address [4] 291730 0
Department of Health Nutrition
Universitas Gadjah Mada
Jl. Farmako Sekip, Yogyakarta, Indonesia 55281
Country [4] 291730 0
Indonesia
Other collaborator category [1] 278853 0
Individual
Name [1] 278853 0
A/Prof. John Hayball
Address [1] 278853 0
School of Pharmacy and Medical Sciences
R4-26, Reid Bld, City East.
University of South Australia
North Tce, Adelaide, SA 5000.
Country [1] 278853 0
Australia
Other collaborator category [2] 278854 0
Individual
Name [2] 278854 0
Mrs Robyn Kievit
Address [2] 278854 0
School of Pharmacy and Medical Sciences
R4-26, Reid Bld, City East.
University of South Australia
North Tce, Adelaide, SA 5000.
Country [2] 278854 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294462 0
Medical and Health Research Ethics Committee (MHREC) Faculty of Medicine, Gadjah Mada University - Dr. Sardjito General Hospital
Ethics committee address [1] 294462 0
Ethics committee country [1] 294462 0
Indonesia
Date submitted for ethics approval [1] 294462 0
03/08/2015
Approval date [1] 294462 0
14/09/2015
Ethics approval number [1] 294462 0
KE/FK/1177/EC/2015

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 775 775 0 0
/AnzctrAttachments/370192-HREC Approval - UGM.pdf
Attachments [2] 776 776 0 0
/AnzctrAttachments/370192-HREC Approval of Notification form - Indonesian Study.pdf
Attachments [3] 777 777 0 0
/AnzctrAttachments/370192-RME Applications - New Human Research Approval Notification.pdf

Contacts
Principal investigator
Name 63826 0
Mr Tony Arjuna
Address 63826 0
Discipline of Medicine, University of Adelaide
Level 6, Eleanor Harrald Building
Frome Road, Adelaide SA 5005
Country 63826 0
Australia
Phone 63826 0
+62882225073
Fax 63826 0
Email 63826 0
[email protected]
Contact person for public queries
Name 63827 0
Tony Arjuna
Address 63827 0
Discipline of Medicine, University of Adelaide
Level 6, Eleanor Harrald Building
Frome Road, Adelaide SA 5005
Country 63827 0
Australia
Phone 63827 0
+62882225073
Fax 63827 0
Email 63827 0
[email protected]
Contact person for scientific queries
Name 63828 0
Tony Arjuna
Address 63828 0
Discipline of Medicine, University of Adelaide
Level 6, Eleanor Harrald Building
Frome Road, Adelaide SA 5005
Country 63828 0
Australia
Phone 63828 0
+62882225073
Fax 63828 0
Email 63828 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
No documents have been uploaded by study researchers.

Documents added automatically
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