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Trial registered on ANZCTR
Registration number
ACTRN12614000827639
Ethics application status
Approved
Date submitted
22/07/2014
Date registered
4/08/2014
Date last updated
6/04/2022
Date data sharing statement initially provided
6/04/2022
Date results provided
6/04/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Does nutrition and exercise prevent frailty and reduce falls in pre-frail older adults in New Zealand?
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Scientific title
A randomised controlled trial to examine the effectiveness of a complex intervention in reducing falls and frailty among pre-frail elderly
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Secondary ID [1]
285041
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Nil known
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Universal Trial Number (UTN)
U1111-1158-6314
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Trial acronym
SUPER Study
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Falls
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Age-associated frailty
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Condition category
Condition code
Public Health
292860
292860
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0
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Health promotion/education
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Injuries and Accidents
292916
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0
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Other injuries and accidents
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention consist of Senior Chef (Nutrition) programme, Steady As You Go programme (SAYGO; physical activity) or both
Participants will be randomised into 1) Senior Chef Group, 2) SAYGO group, 3) a group consisting of both Senior Chef and SAYGO or 4) the control group. Participants in the group 3 (Senior Chef and SAYGO) will attend 2 classes in a week.
The Senior Chef is an 8-week programme consisting of 3-hour weekly hands-on cooking classes followed by sharing the food cooked that day, nutrition education including menu planning, budgeting and shopping tips delivered by a trained facilitator. There are 10 participants per class
The Steady As You Go programme (SAYGO) is a 1-hour weekly for 10-week strength and balance exercise programme based on the adapted Otago Exercise Programme. The programmed focuses on peer-led exercises, rather than peer-led education alone. There are 10 participants per class. The exercise programme consist of seated flexibility, range of motion, and seated aerobic exercises taught by a trained instructor. SAYGO is between 2-4 on a 10 point Rating of Perceived Exertion scale.
Facilitators will maintain an attendance log to monitor adherence.
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Intervention code [1]
289876
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Lifestyle
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Intervention code [2]
289877
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Prevention
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Comparator / control treatment
The comparator group is the social course where people gather to do activities that are productive, share a cup of tea and talk. It takes about two hours every week for 10 weeks. The focus of the social groups is contact and interaction. There is no educational focus. Refreshments are usually part of the social outing.
Enjoying company is important to wellbeing in older age
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Control group
Active
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Outcomes
Primary outcome [1]
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Frailty as assessed using the Fried Score
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Assessment method [1]
292735
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Timepoint [1]
292735
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0, 6, 12 and 24 months after completion of the intervention programme
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Secondary outcome [1]
309574
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Falls as assessed using monthly falls diary
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Assessment method [1]
309574
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Timepoint [1]
309574
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0, 6, 12 and 24 months after completion of the intervention programme
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Secondary outcome [2]
309575
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Physical performance as assessed using the Short Physical Performance Battery (SPPB)
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Assessment method [2]
309575
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Timepoint [2]
309575
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0, 6, 12 and 24 months after completion of the intervention programme
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Secondary outcome [3]
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Functional status is assessed using the Nottingham Extended Activities of Daily Living Scale (NEADL)
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Assessment method [3]
309576
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Timepoint [3]
309576
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0, 6, 12 and 24 months after completion of the intervention programme
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Secondary outcome [4]
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Health related quality of life (HR-QOL) is assessed using the SF-12 including the summary scores for physical and mental health-related QOL
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Assessment method [4]
309577
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Timepoint [4]
309577
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0, 6, 12 and 24 months after completion of the intervention programme
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Secondary outcome [5]
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Food intake is assessed using two multiple pass recalls (MPR) on two separate days to record detailed dietary information.
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Assessment method [5]
309578
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Timepoint [5]
309578
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6, 12 and 24 months after completion of the intervention programme
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Secondary outcome [6]
309579
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Physical activity is assessed using the Community Healthy Activities Model Program for Seniors - CHAMPS Activities Questionnaire
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Assessment method [6]
309579
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Timepoint [6]
309579
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6, 12 and 24 months after completion of the intervention programme
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Eligibility
Key inclusion criteria
- Age criteria: Non-Maori 75 years and over; Maori aged 60 and over
- Living in the community
- Pre-frail using criteria of 1 or 2 score on the FRAIL questionnaire
- Able to communicate in English or te reo or have someone who can translate
- Able to use the kitchen utensils safely
- Able to stand
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- Terminally ill as judged by the general practitioner or Maori health provider.
- Advanced dementia from GP records
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratify block randomisation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Factorial
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
18/08/2014
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Actual
1/09/2014
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Date of last participant enrolment
Anticipated
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Actual
30/03/2018
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Date of last data collection
Anticipated
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Actual
8/09/2020
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Sample size
Target
635
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Accrual to date
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Final
516
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Recruitment outside Australia
Country [1]
6245
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New Zealand
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State/province [1]
6245
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Funding & Sponsors
Funding source category [1]
289647
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Government body
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Name [1]
289647
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Health Research Council of New Zealand
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Address [1]
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Level 3, 110 Stanley Street
Auckland 1010
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Country [1]
289647
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New Zealand
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Funding source category [2]
289648
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Government body
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Name [2]
289648
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Ministry of Business, Innovation and Employment through the National Science Challenge Ageing Well program
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Address [2]
289648
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Ministry of Business, Innovation and Employment
MBIE Science offices
Wellington office
Level 3, 33 Bowen Street
PO Box 5762
Wellington 6145
Auckland office
Level 6, Tower Centre
45 Queen Street
PO Box 106 483
Auckland 1143
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Country [2]
289648
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New Zealand
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Primary sponsor type
University
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Name
The University of Auckland
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Address
Tamaki Campus
Building 730
261 Morrin Rd
St Johns
Auckland 1072
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Country
New Zealand
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Secondary sponsor category [1]
288401
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Individual
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Name [1]
288401
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Ruth Teh
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Address [1]
288401
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Tamaki Campus
Building 730
University of Auckland
261 Morrin Rd
St Johns
Auckland 1072
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Country [1]
288401
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
291387
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Health and Disability Ethics Committee
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Ethics committee address [1]
291387
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Ministry of Health No 1 The Terrace PO Box 5013 Wellington 6011
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Ethics committee country [1]
291387
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New Zealand
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Date submitted for ethics approval [1]
291387
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25/07/2014
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Approval date [1]
291387
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13/08/2014
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Ethics approval number [1]
291387
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14/STH/101
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Summary
Brief summary
Age-associated frailty is a significant cause of disability and dependency. Physical frailty and falls predict, fractures, mobility/functional decline, residential care admissions, hospitalisations and death. Often, older people who fell have serious personal and societal consequences. Studies showed that maintaining function and quality of life (QOL) are preferred over longevity, and healthy lifestyle behaviours benefit QOL and function. However physical activity is low and nutrition risk high in older people. To date, most studies test a single programme (either physical activity or nutrition) with few combining both strategies in community setting. This study aims to answer this main question “Does eating well and moving about more make life happier and easier by decreasing falls and reducing frailty?” We believe physical activity go with active ageing and new ways to cook will help an older person to eat better. Changing the way of living and ageing will prevent the progression of frailty and reduce the risk of falling over. The study, if successful, will have a positive impact on reducing health services and prolonging healthy life expectancy.
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Trial website
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Trial related presentations / publications
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Public notes
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Attachments [1]
872
872
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/AnzctrAttachments/366773-HDEC Letter - 14STH101 - APPROVED Expedited Application.pdf
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Attachments [2]
873
873
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/AnzctrAttachments/366773-HDEC Letter - 14STH101AM01 -Approved Amendment.pdf
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Attachments [3]
874
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/AnzctrAttachments/366773-HDEC Letter 14STH101AM03 Approved Amendment.pdf
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Contacts
Principal investigator
Name
50150
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Dr Ruth Teh
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Address
50150
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Level 3, Building 507
School of Population Health
University of Auckland Grafton Campus
22-30 Park Ave
Grafton
Auckland 1023
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Country
50150
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New Zealand
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Phone
50150
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+64 9 9237517
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Fax
50150
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Email
50150
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[email protected]
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Contact person for public queries
Name
50151
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Ruth Teh
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Address
50151
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Level 3, Building 507
School of Population Health
University of Auckland Grafton Campus
22-30 Park Ave
Grafton
Auckland 1023
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Country
50151
0
New Zealand
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Phone
50151
0
+64 9 9237517
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Fax
50151
0
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Email
50151
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[email protected]
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Contact person for scientific queries
Name
50152
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Ngaire Kerse
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Address
50152
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The School of Population Health
Tamaki Campus
University of Auckland
261 Morrin Rd St Johns
Auckland 1072
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Country
50152
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New Zealand
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Phone
50152
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+64 9 923 4467
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Fax
50152
0
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Email
50152
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Need consultation with study participants, stakeholder and funder
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
15705
Study protocol
Teh R, Kerse N, Waters DL, Hale L, Pillai A, Leilua E, et al. Study protocol of a randomised controlled trial to examine the impact of a complex intervention in pre-frail older adults. Aging Clin Exp Res. 2019;31(10):1407-17.
https://doi.org/10.1007/s40520-018-1106-7
[email protected]
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Study protocol of a randomised controlled trial to examine the impact of a complex intervention in pre-frail older adults.
2019
https://dx.doi.org/10.1007/s40520-018-1106-7
Embase
Effectiveness of a complex intervention of group-based nutrition and physical activity to prevent frailty in pre-frail older adults (SUPER): a randomised controlled trial.
2022
https://dx.doi.org/10.1016/S2666-7568%2822%2900124-6
N.B. These documents automatically identified may not have been verified by the study sponsor.
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