Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001312932
Ethics application status
Approved
Date submitted
23/09/2020
Date registered
7/12/2020
Date last updated
7/12/2020
Date data sharing statement initially provided
7/12/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of two healthy lifestyle and exercise support programs for adults aged 60 and over: a randomised controlled trial (Healthy and Active for life trial)
Scientific title
Evaluation of two healthy lifestyle and exercise support programs for adults aged 60 and over: a randomised controlled trial (Healthy and Active for life trial) investigating the impact on physical activity
Secondary ID [1] 301713 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls
 318303 0
Physical inactivity 318304 0
Poor diet 319549 0
Condition category
Condition code
Public Health 316316 316316 0 0
Health promotion/education
Physical Medicine / Rehabilitation 316317 316317 0 0
Other physical medicine / rehabilitation
Diet and Nutrition 317498 317498 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Healthy and Active for Life program is composed of 10 weekly face-to-face group sessions, that run for 2 hours.
-The program engages participants in a number of circuit exercises (60 minutes), facilitates discussion sessions around diet/nutrition, physical activity, and building strength/balance in older adults (45 minutes), and allows 15 minutes for a break/socialisation.
-The circuit exercises aim to build strength and balance, including heel-to-toe walking, side leg raises. Circuits include easy versions of each exercise for participants that are more frail.
-The weekly sessions will be run by a trained health professional (physiotherapist, exercise physiologist, dietitian etc), who will oversee the exercises as well as facilitate the information sessions. Participants of the program will receive hard-copies of all resources in the first week. Adherence to the intervention will be recorded by the facilitator via attendance sheets.
-The educational materials for Healthy and Active for Life and Healthy and Active for Life Online were developed specifically for the programs, and are not widely available.

The Healthy and Active for Life Online program is the digital implementation of Healthy and Active for Life Online.
-Participants log into a personalised web-portal where they can access the same resources and exercises from Healthy and Active for Life Online.
-The program is self-guided, and participants will receive 10 weekly telephone support calls from trained health professionals (same as those who deliver Healthy and Active for Life).
-The telephone support will cover the contents from the modules, help participants set healthy lifestyle goals, and implement plans for achieving those goals. Each call will be around 20 minutes in duration.
-An online module is unlocked each week to follow the schedule of the face-to-face program and participants can revisit modules that have been unlocked. The online program is expected to be completed in 10 weeks, and the health professional will help participants adhere to this schedule in the weekly coaching calls. The online modules were designed to be completed within 1 hour.
-Adherence to the program will be determined via module click-through and attendance in phone support sessions recorded by the health professional.
Intervention code [1] 318123 0
Lifestyle
Intervention code [2] 318967 0
Prevention
Comparator / control treatment
Participants in the control group receive educational materials (booklet) with information similar to the intervention arms. The booklet is accessible to the public at: https://www.activeandhealthy.nsw.gov.au/preventing-falls/staying-active-and-on-your-feet/
Control group
Active

Outcomes
Primary outcome [1] 324487 0
Physical activity/week assessed via self report
Timepoint [1] 324487 0
12 month follow-up - a single data collection session to be conducted 12 months after graduating from the 10 week program, The session will ask about the number of sessions of physical activity that was done over the past week.
Secondary outcome [1] 384788 0
Number of fruit serves consumed per day assessed via self-report
Timepoint [1] 384788 0
12 month follow-up - a single data collection session to be conducted 12 months after graduating from the 10 week program, The session will ask about the number of serves of fruit a participant usually consumes/day
Secondary outcome [2] 384789 0
Number of vegetable serves consumed per day assessed via self report
Timepoint [2] 384789 0
12 month follow-up - a single data collection session to be conducted 12 months after graduating from the 10 week program, The session will ask about the number of serves of vegetables a participant usually consumes/day
Secondary outcome [3] 384790 0
Number of falls measured via self-report
Timepoint [3] 384790 0
12 month follow-up - a single data collection session to be conducted 12 months after graduating from the 10 week program, The session will ask about the total number of falls a participant has experienced since graduating from the program (cumulative over past 12 months),
Secondary outcome [4] 388470 0
Social inclusion assessed via the 'Friendship Scale' (self reported measure).
Hawthorne G. Measuring social isolation in older adults: development and initial validation of the friendship scale. Social indicators research. 2006 Jul 1;77(3):521-48.
Timepoint [4] 388470 0
12 month follow-up - a single data collection session to be conducted 12 months after graduating from the 10 week program, The session will ask questions about social inclusion over the past 4 weeks.

Eligibility
Key inclusion criteria
-Are 60 years or older
-Are independently mobile with or without walking frames/canes (can walk without the assistance of another person)
-Are able to speak and understand English
-Do not have a cognitive impairment (dementia, Parkinson’s) that affects their ability to do gentle exercise or participate in a group setting
- Are able to participate in gentle exercise in a group setting
- Has not participated in the Stepping On program in the past 3 years
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Has participated in the Stepping On program in the past 3 years

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 via computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Linear mixed effects models will be used to assess the differences in outcomes across time (physical activity, fruit/veg serves, social inclusion).
Negative binomial regression will be used to assess incidence of falls at the 12 month follow-up.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2021
Actual
Date of last participant enrolment
Anticipated
1/02/2022
Actual
Date of last data collection
Anticipated
1/03/2023
Actual
Sample size
Target
900
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306150 0
Government body
Name [1] 306150 0
NSW Ministry of Health
Country [1] 306150 0
Australia
Primary sponsor type
Hospital
Name
Liverpool Hospital
Address
Cnr Elizabeth & Goulburn St
Liverpool NSW 2170
Country
Australia
Secondary sponsor category [1] 306619 0
None
Name [1] 306619 0
Address [1] 306619 0
Country [1] 306619 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306368 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 306368 0
Ethics committee country [1] 306368 0
Australia
Date submitted for ethics approval [1] 306368 0
15/07/2020
Approval date [1] 306368 0
03/08/2020
Ethics approval number [1] 306368 0
2020/ETH01623

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

Contacts
Principal investigator
Name 103634 0
Dr Joe Xu
Address 103634 0
Level 1, Don Everett Building
West End, Liverpool Hospital
Elizabeth Street
Liverpool, NSW 2170
Country 103634 0
Australia
Phone 103634 0
+61 436 930 879
Fax 103634 0
Email 103634 0
joe.xu@health.nsw.gov.au
Contact person for public queries
Name 103635 0
Joe Xu
Address 103635 0
Level 1, Don Everett Building
West End, Liverpool Hospital
Elizabeth Street
Liverpool, NSW 2170
Country 103635 0
Australia
Phone 103635 0
+61 436 930 879
Fax 103635 0
Email 103635 0
joe.xu@health.nsw.gov.au
Contact person for scientific queries
Name 103636 0
Joe Xu
Address 103636 0
Level 1, Don Everett Building
West End, Liverpool Hospital
Elizabeth Street
Liverpool, NSW 2170
Country 103636 0
Australia
Phone 103636 0
+61 436 930 879
Fax 103636 0
Email 103636 0
joe.xu@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will only be shared at the aggregated level consistent with the ethics submission


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
No additional documents have been identified.