Trial Review

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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 information initially 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?
Scientific title
A randomised controlled trial to examine the effectiveness of a complex intervention in reducing falls and frailty among pre-frail elderly
Secondary ID [1] 285041 0
Nil known
Universal Trial Number (UTN)
U1111-1158-6314
Trial acronym
SUPER Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 292553 0
Age-associated frailty 292554 0
Condition category
Condition code
Public Health 292860 292860 0 0
Health promotion/education
Injuries and Accidents 292916 292916 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 289876 0
Lifestyle
Intervention code [2] 289877 0
Prevention
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
Control group
Active

Outcomes
Primary outcome [1] 292735 0
Frailty as assessed using the Fried Score
Timepoint [1] 292735 0
0, 6, 12 and 24 months after completion of the intervention programme
Secondary outcome [1] 309574 0
Falls as assessed using monthly falls diary
Timepoint [1] 309574 0
0, 6, 12 and 24 months after completion of the intervention programme
Secondary outcome [2] 309575 0
Physical performance as assessed using the Short Physical Performance Battery (SPPB)
Timepoint [2] 309575 0
0, 6, 12 and 24 months after completion of the intervention programme
Secondary outcome [3] 309576 0
Functional status is assessed using the Nottingham Extended Activities of Daily Living Scale (NEADL)
Timepoint [3] 309576 0
0, 6, 12 and 24 months after completion of the intervention programme
Secondary outcome [4] 309577 0
Health related quality of life (HR-QOL) is assessed using the SF-12 including the summary scores for physical and mental health-related QOL
Timepoint [4] 309577 0
0, 6, 12 and 24 months after completion of the intervention programme
Secondary outcome [5] 309578 0
Food intake is assessed using two multiple pass recalls (MPR) on two separate days to record detailed dietary information.
Timepoint [5] 309578 0
6, 12 and 24 months after completion of the intervention programme
Secondary outcome [6] 309579 0
Physical activity is assessed using the Community Healthy Activities Model Program for Seniors - CHAMPS Activities Questionnaire
Timepoint [6] 309579 0
6, 12 and 24 months after completion of the intervention programme

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
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Terminally ill as judged by the general practitioner or Maori health provider.
- Advanced dementia from GP records

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratify block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/08/2014
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
30/03/2018
Date of last data collection
Anticipated
Actual
8/09/2020
Sample size
Target
635
Accrual to date
Final
516
Recruitment outside Australia
Country [1] 6245 0
New Zealand
State/province [1] 6245 0

Funding & Sponsors
Funding source category [1] 289647 0
Government body
Name [1] 289647 0
Health Research Council of New Zealand
Country [1] 289647 0
New Zealand
Funding source category [2] 289648 0
Government body
Name [2] 289648 0
Ministry of Business, Innovation and Employment through the National Science Challenge Ageing Well program
Country [2] 289648 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Tamaki Campus
Building 730
261 Morrin Rd
St Johns
Auckland 1072
Country
New Zealand
Secondary sponsor category [1] 288401 0
Individual
Name [1] 288401 0
Ruth Teh
Address [1] 288401 0
Tamaki Campus
Building 730
University of Auckland
261 Morrin Rd
St Johns
Auckland 1072
Country [1] 288401 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291387 0
Health and Disability Ethics Committee
Ethics committee address [1] 291387 0
Ministry of Health
No 1 The Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 291387 0
New Zealand
Date submitted for ethics approval [1] 291387 0
25/07/2014
Approval date [1] 291387 0
13/08/2014
Ethics approval number [1] 291387 0
14/STH/101

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.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 872 872 0 0
/AnzctrAttachments/366773-HDEC Letter - 14STH101 - APPROVED Expedited Application.pdf
Attachments [2] 873 873 0 0
/AnzctrAttachments/366773-HDEC Letter - 14STH101AM01 -Approved Amendment.pdf
Attachments [3] 874 874 0 0
/AnzctrAttachments/366773-HDEC Letter 14STH101AM03 Approved Amendment.pdf

Contacts
Principal investigator
Name 50150 0
Dr Ruth Teh
Address 50150 0
Level 3, Building 507
School of Population Health
University of Auckland Grafton Campus
22-30 Park Ave
Grafton
Auckland 1023
Country 50150 0
New Zealand
Phone 50150 0
+64 9 9237517
Fax 50150 0
Email 50150 0
[email protected]
Contact person for public queries
Name 50151 0
Dr Ruth Teh
Address 50151 0
Level 3, Building 507
School of Population Health
University of Auckland Grafton Campus
22-30 Park Ave
Grafton
Auckland 1023
Country 50151 0
New Zealand
Phone 50151 0
+64 9 9237517
Fax 50151 0
Email 50151 0
[email protected]
Contact person for scientific queries
Name 50152 0
Prof Ngaire Kerse
Address 50152 0
The School of Population Health
Tamaki Campus
University of Auckland
261 Morrin Rd St Johns
Auckland 1072
Country 50152 0
New Zealand
Phone 50152 0
+64 9 923 4467
Fax 50152 0
Email 50152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Need consultation with study participants, stakeholder and funder


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15705Study protocolTeh 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Tay, E., Barnett, D., Leilua, E., Kerse, N., Rowla... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseStudy protocol of a randomised controlled trial to examine the impact of a complex intervention in pre-frail older adults.2019https://dx.doi.org/10.1007/s40520-018-1106-7
EmbaseEffectiveness of a complex intervention of group-based nutrition and physical activity to prevent frailty in pre-frail older adults (SUPER): a randomised controlled trial.2022https://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.