ANZCTR - Registration

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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]

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

Condition category

Condition code

Public Health

Health promotion/education

Public Health

Health service research

Physical Medicine / Rehabilitation

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Average daily step counts as measured by pedometer for 7 consecutive days.

Timepoint [1]

Three and 12 months after randomisation.

Secondary outcome [1]

self-reported physical activity levels as measured by the Active Australia survey

Timepoint [1]

Three and 12 months after randomisation.

Secondary outcome [2]

Self-reported waist circumference

Timepoint [2]

Three and 12 months after randomisation.

Secondary outcome [3]

Body mass index (calculated from self-reported height and weight)

Timepoint [3]

Three and 12 months after randomisation.

Secondary outcome [4]

Quality of life as measured by the AQOL-8D

Timepoint [4]

Three and 12 months after randomisation.

Secondary outcome [5]

Depressive symptoms as measured by the Centre for Epidemiological Studies Depression scale (CES-D)

Timepoint [5]

Three and 12 months after randomisation.

Secondary outcome [6]

6 items measuring self-reported sedentary behaviour

Timepoint [6]

Three and 12 months after randomisation.

Secondary outcome [7]

3 items assessing the amount and frequency of dog walking

Timepoint [7]

Three and 12 months after randomisation.

Secondary outcome [8]

22 items assessing the social cognitive mediators of physical activity (intention, self-efficacy, outcome expectations, social support)

Timepoint [8]

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]

Government body

Name [1]

National Health and Medical Research Council/Project Grant

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Newcastle

Address

University Drive
Callaghan NSW 2308

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee,
Research Office,
East Wing, The Chancellery
The University of Newcastle
University Dr
Callaghan NSW 2308

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

24/05/2011

Ethics approval number [1]

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

A/Prof Erica James

Address

School of Medicine and Public Health, The University of Newcastle, W4 HMRI Building, University Dr, Callaghan NSW 2308

Country

Australia

Phone

+61 2 4042 0562

Fax

Email

Erica.James@newcastle.edu.au

Contact person for public queries

Name

Fiona Stacey, Research Manager

Address

School of Medicine and Public Health, The University of Newcastle, W4 HMRI Building, University Dr, Callaghan NSW 2308

Country

Australia

Phone

+61 2 4042 0555

Fax

+61 2 4042 0044

Email

fiona.stacey@newcastle.edu.au

Contact person for scientific queries

Name

Erica James

Address

School of Medicine and Public Health, The University of Newcastle, W4 HMRI Building, University Dr, Callaghan NSW 2308

Country

Australia

Phone

+61 2 4042 0562

Fax

+61 2 4042 0044

Email

Erica.James@newcastle.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Efficacy of GP referral of insufficiently active patients for expert physical activity counseling: protocol for a pragmatic randomized trial (The NewCOACH trial).	2014	https://dx.doi.org/10.1186/s12875-014-0218-1
Embase	Referral for Expert Physical Activity Counseling: A Pragmatic RCT.	2017	https://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.