Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000884909
Ethics application status
Approved
Date submitted
18/08/2011
Date registered
18/08/2011
Date last updated
31/03/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
NewCOACH: Comparison of Activity Coaching for Health
Scientific title
In adult primary care patients does exercise physiologist counselling result in their having greater step counts at 3 and 12 months than controls given printed physical activity advice?
Secondary ID [1] 262785 0
Nil
Universal Trial Number (UTN)
U1111-1119-9393
Trial acronym
NewCOACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insufficient physical activity 270492 0
Condition category
Condition code
Public Health 270648 270648 0 0
Health promotion/education
Public Health 270649 270649 0 0
Health service research
Physical Medicine / Rehabilitation 270650 270650 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three study arms.
Arm 1 (face-to-face counselling): Participants will receive 5 face-to-face visits with an exercise physiologist (EP) over a 3 month period from randomisation. The EP will conduct a fitness assessment at the first visit (1-hour)and a written exercise plan will be negotiated in consultation with the patient. At follow-up sessions (30 minutes), the EP will work with the patient in setting and reviewing goals, motivaton, and discussing barriers and ways to overcome these.
Arm 2 (face-to-face and telephone counselling): Participants will attend the same initial 1-hour face-to-face appointment with an EP as Arm 1. Follow-up will be via 4 telephone calls by the same EP. The visit and calls will occur within a 3 month period from randomisation.
Arm 3: Printed materials giving physical activity advice on one occasion at randomisation.
Intervention code [1] 269125 0
Prevention
Intervention code [2] 269126 0
Lifestyle
Intervention code [3] 269127 0
Behaviour
Comparator / control treatment
The usual care comparison group involves the provision of generic print material designed to promote physical activity.
Control group
Active

Outcomes
Primary outcome [1] 269372 0
Average daily step counts as measured by pedometer for 7 consecutive days.
Timepoint [1] 269372 0
Three and 12 months after randomisation.
Secondary outcome [1] 279478 0
self-reported physical activity levels as measured by the Active Australia survey
Timepoint [1] 279478 0
Three and 12 months after randomisation.
Secondary outcome [2] 279479 0
Self-reported waist circumference
Timepoint [2] 279479 0
Three and 12 months after randomisation.
Secondary outcome [3] 279480 0
Body mass index (calculated from self-reported height and weight)
Timepoint [3] 279480 0
Three and 12 months after randomisation.
Secondary outcome [4] 279481 0
Quality of life as measured by the AQOL-8D
Timepoint [4] 279481 0
Three and 12 months after randomisation.
Secondary outcome [5] 279483 0
Depressive symptoms as measured by the Centre for Epidemiological Studies Depression scale (CES-D)
Timepoint [5] 279483 0
Three and 12 months after randomisation.
Secondary outcome [6] 279485 0
6 items measuring self-reported sedentary behaviour
Timepoint [6] 279485 0
Three and 12 months after randomisation.
Secondary outcome [7] 279486 0
3 items assessing the amount and frequency of dog walking
Timepoint [7] 279486 0
Three and 12 months after randomisation.
Secondary outcome [8] 287680 0
22 items assessing the social cognitive mediators of physical activity (intention, self-efficacy, outcome expectations, social support)
Timepoint [8] 287680 0
Three and 12 months after randomisation.

Eligibility
Key inclusion criteria
* Primary care patients
* Aged 18 years or older
* Insufficiently active, defined by 7 days of step counts with average step count of less than 7000 steps per day
* Fluent in English
* Able to give informed consent
* Telephone access
* Planning to live in greater Newcastle/Hunter region or Inner West Sydney areas for the next 12 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Too frail/disabled to benefit from either of the interventions (as measured by Timed Up and Go 3 metre test). Participants need to be able to complete the test within 19.9 seconds to be eligible. This is used as part of the initial screening, prior to randomisation.
* Deemed unsafe to exercise following exercise physiologist assessment (post-randomisation).

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)
Patients will be recruited at General Practitioner (GP) clinics. Interested patients will book an appointment time with a Research Assistant (RA) at the clinic. During this appointment, patients are provided with an information statement and consent form, and can discuss the trial with the RA. If the patient consents to take part, they will complete a Timed Up and Go assessment to confirm they are not too frail to participate.
Eligible and consenting patients will be given a baseline survey, and movement recorder to wear for 7 consecutive days, movement recorder log sheet, paper tape measure to measure waist circumference, as well as a reply paid envelope to return materials to the research team.
Once these materials have been returned via mail, the Research Manager will determine if the patient is insufficiently active (and therefore eligible to continue with the study) based on their average daily step count. The Research Manager will be responsible for informing patients of their study group allocation (by letter).
Allocation will be by a 2 stage randomisation procedure conducted by an independent statistician. Firstly by simple randomisation to control or intervention group, in a ratio of 1:2. Secondly for those allocated to intervention group, participants will be stratified by gender, and by their choice of EP location then randomised equally to arm 1 and arm 2.
Allocation will be unknown to the GP and to the RA at the time of recruitment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequence for the first stage of randomisation (i.e. active treatment or control) will be generated using a randomised block design stratified by gender. Allocation in the ratio of 2 to active treatment for each 1 to control will occur at a centralised location by an independent statistician.

The sequence for the second stage of randomisation (i.e. face to face or telephone counselling) will be generated using randomised block design stratified by participant gender and the location of the intervention service. Allocation in the ratio of 1 to 1 to each active treatment arm will occur at a centralised location by an independent statistician using appropriate 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
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/09/2011
Actual
30/09/2011
Date of last participant enrolment
Anticipated
Actual
20/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
261
Accrual to date
Final
203
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 269606 0
Government body
Name [1] 269606 0
National Health and Medical Research Council/Project Grant
Country [1] 269606 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 266637 0
None
Name [1] 266637 0
Address [1] 266637 0
Country [1] 266637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269554 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 269554 0
Human Research Ethics Committee,
Research Office,
East Wing, The Chancellery
The University of Newcastle
University Dr
Callaghan NSW 2308
Ethics committee country [1] 269554 0
Australia
Date submitted for ethics approval [1] 269554 0
Approval date [1] 269554 0
24/05/2011
Ethics approval number [1] 269554 0
H-2011-0063

Summary
Brief summary
A randomised controlled trial will be conducted to determine the efficacy of two physical activity (PA) counselling strategies on PA behaviour over a 12 month period amongst insufficiently active adults attending general practices in the Newcastle, Lake Macquarie, Hunter, and Inner West Sydney areas of New South Wales. Participants will be randomly allocated to one of 3 groups: a) face-to-face counselling by an exercise specialist; b) one face-to-face visit followed by telephone counselling by an exercise specialist; or c) receive generic print materials in the mail promoting PA. The primary outcomes will be pedometer steps at 12 months.
Trial website
Trial related presentations / publications
James E, Ewald B, Johnson N, Brown W, Stacey FG, McElduff P, Booth A, Yang F, Hespe C, Plotnikoff RC. Efficacy of GP referral of insufficiently active patients for expert physical activity counselling: protocol for a pragmatic randomized trial (The NewCOACH trial). BMC Family Practice. 2014: 15: 218. DOI 10.1186/s12875-014-0218-1

James EL, Ewald B, Johnson N, Brown W, Stacey FG, Plotnikoff RC. Using objective assessment to determine eligibility to participate in a randomized controlled trial (The NewCOACH trial). International Society of Behavioral Nutrition and Physical Activity, 3-6 June 2015, Edinburgh Scotland (poster).
Public notes

Contacts
Principal investigator
Name 32980 0
A/Prof Erica James
Address 32980 0
School of Medicine and Public Health, The University of Newcastle, W4 HMRI Building, University Dr, Callaghan NSW 2308
Country 32980 0
Australia
Phone 32980 0
+61 2 4042 0562
Fax 32980 0
Email 32980 0
[email protected]
Contact person for public queries
Name 16227 0
Fiona Stacey, Research Manager
Address 16227 0
School of Medicine and Public Health, The University of Newcastle, W4 HMRI Building, University Dr, Callaghan NSW 2308
Country 16227 0
Australia
Phone 16227 0
+61 2 4042 0555
Fax 16227 0
+61 2 4042 0044
Email 16227 0
[email protected]
Contact person for scientific queries
Name 7155 0
Erica James
Address 7155 0
School of Medicine and Public Health, The University of Newcastle, W4 HMRI Building, University Dr, Callaghan NSW 2308
Country 7155 0
Australia
Phone 7155 0
+61 2 4042 0562
Fax 7155 0
+61 2 4042 0044
Email 7155 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
SourceTitleYear of PublicationDOI
EmbaseEfficacy of GP referral of insufficiently active patients for expert physical activity counseling: protocol for a pragmatic randomized trial (The NewCOACH trial).2014https://dx.doi.org/10.1186/s12875-014-0218-1
EmbaseReferral for Expert Physical Activity Counseling: A Pragmatic RCT.2017https://dx.doi.org/10.1016/j.amepre.2017.06.016
N.B. These documents automatically identified may not have been verified by the study sponsor.