Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001309471
Ethics application status
Approved
Date submitted
16/08/2016
Date registered
19/09/2016
Date last updated
7/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
SMART Health Teachers’ Study – A community-based physical activity study for teachers with Type 2 diabetes (T2D) or 'at risk' of developing T2D.
Scientific title
Preliminary efficacy and feasibility of referral to exercise specialists,
psychologists and provision of a technology-based behaviour change support
package to promote physical activity in school teachers ‘at risk' of, or
diagnosed with, type 2 diabetes: The SMART Health Study Protocol.
Secondary ID [1] 290083 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SMART - Support, Motivation and Physical Activity Research for Teachers' Health
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity (primary) 298664 0
Overweight 298665 0
Obesity 298666 0
Hypertension 298667 0
Dyslipidaemia 298668 0
Hyperglycaemia 298669 0
Depression 298670 0
Anxiety 298671 0
Condition category
Condition code
Public Health 298727 298727 0 0
Health promotion/education
Diet and Nutrition 298728 298728 0 0
Obesity
Metabolic and Endocrine 298729 298729 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this randomised controlled trial is to evaluate the preliminary efficacy and feasibility of referral to an Exercise Specialist and Psychologists and supplementary physical activity behaviour change strategies for school teachers ‘at risk' of type 2 diabetes or with type 2 diabetes.

Teachers with type 2 diabetes or at ‘intermediate/high risk’ of developing type 2 diabetes will be randomised to one of 3 groups:

Group 1 - Standard Care group (n=30) = Wait-list control group. At study completion (9 months), participants will receive three face-to-face sessions with a qualified Exercise Specialist sessions and two sessions with a qualified Psychologist, or two qualified exercise specialist sessions and three sessions with a qualified Psychologist (based on individual participant choice), and a behaviour change support package.

Group 2 - Qualified Exercise Specialist sessions / Psychologist group (n=30). Participants will receive three face-to-face sessions with a qualified Exercise Specialist and two sessions with a qualified Psychologist OR two qualified Exercise Specialist sessions and three sessions with a qualified Psychologist (based on individual participant choice) over three months. At study completion (9-months), Group 2 participants will also be offered the behaviour change support package.

Group 3 - Qualified Exercise Specialist sessions / Psychologist + Support Package group (n=30) = Participants will receive three face-to-face sessions with a qualified Exercise Specialist and two sessions with a qualified Psychologist OR two qualified Exercise Specialist sessions and three sessions with a qualified Psychologist (based on individual participant choice), over three months, followed by a behaviour change support package (e-health, m-health and help-line) (additional six months). The support package will include e-health (website access, with options to download print materials) and m-health (iPhone/android app) strategies and/or the option of receiving print-based materials by post.

The sessions with the Exercise Specialist and Psychologist will be held fortnightly at the University of Newcastle (or Muswellbrook Hospital for rural participants). The first session will be 45 minutes in duration and subsequent appointments will be 30 minutes in duration. The Exercise Specialist will be assessing participants' current level of fitness and capacity for participating in physical activity using behaviour change techniques to encourage participants to increase physical activity. The psychologist will be using behaviour change techniques to encourage participants to increase their level of physical activity. The content of these sessions is further described in a protocol booklet.

The Exercise Specialist and Psychologist will keep a written log detailing the frequency, duration and content of their face to face sessions with the participants.

The following is a summary of the material covered with participants in the sessions with the Exercise Specialist and Psychologist:

Session 1 (Psychologist):
Introduce the participant to the session flow and cognitive-behaviour techniques (purpose and rationale), educate participants about the influence of thoughts and emotions on physical activity behaviour, discuss motivational techniques and types of automatic thoughts, address the importance of tracking and changing automatic thoughts, acknowledge the importance of behavioural tasks in the program.

Session 2: (Exercise Specialist):
Assess restrictions to activity/previous injury, participants’ ability to safely perform physical activity, level of confidence to change behaviour, historical enablers for reaching physical activity goals. Discuss the importance of physical activity, benefits of increasing physical activity, having good time management. Set physical activity goals and assist participants to complete weekly planner. Using weekly planner, ascertain time available to exercise, equipment available for exercise, people to exercise with. Determine which exercises cannot be performed, provide exercise demonstration, develop a physical activity plan with participants’ input. Address questions/concerns from participant.

Session 3 (Psychologist):
Define unhelpful thinking styles and apply potential solutions for these. Review tasks from session 1 and check if participant had difficulties or noticed/learned anything

Session 4 (Exercise Specialist):
Assess restrictions to activity/previous injury since previous session and participants’ ability to safely perform physical activity. Re-iterate the importance of physical activity and benefits of increasing physical activity. Assess whether participants’ level of confidence to change behaviour has changed. Re-assess physical activity goals and participants' progress towards achieving these. Assess physical activity enablers and barriers since last session – assess participants’ ability to overcome barriers. Assess whether participant has been completing their weekly programme and whether attitude towards physical activity is changing. Discuss any health improvements participants' may have noticed. Re-assess programme plan if necessary.

Session 5 (Psychologist):
Discuss self-awareness task and behaviour maintenance strategy. Implement self-awareness and behaviour maintenance strategy. Summarise previous sessions

Session 5 (Exercise Specialist)
Same flow as session 4. Extend on next steps (Adoption, Implementation, Maintenance; SMART Goals; time management, progression of exercises, variation)

The e-health website and m-health app contain information to assist participants in achieving the physical activity recommendations for Australian adults. This includes information and education to support the behaviour change techniques being used in the face to face sessions with the psychologist and exercise specialist, photos demonstrating various muscle strengthening exercises and links to websites that contain evidence based information about physical activity, diabetes, mental health and nutrition. Participants will be encouraged to access the website and the app as often as they would like. There will be tracking and process measures in place to assess participants' use of the website.

The support package will also include access to a physical activity behaviour ‘helpline’. The helpline counselling will be delivered by a qualified Exercise Specialist and Psychologist (who are appropriately trained in operationalising social cognitive constructs and trained in counselling). The helpline will be open for 4 hours/week for participants to be able to call the Exercise Specialist and 4 hours/week for participants to be able to call the Psychologist. These times will be outlined to participants and participants may have a phone consultation with the Exercise Specialist and/or the Psychologist for up to 15 minutes/week.
Intervention code [1] 294666 0
Behaviour
Intervention code [2] 294667 0
Lifestyle
Intervention code [3] 295625 0
Prevention
Comparator / control treatment
Wait-list control. Participants in the control group will receive standard treatment (e.g. Follow their type 2 diabetes or health management plan if specified by their GP during the intervention period and will be offered the intervention at study completion (9 months).
Control group
Active

Outcomes
Primary outcome [1] 298205 0
Objective physical activity levels: measured using pedometers. Participants will wear a pedometer for 7 consecutive days.
Timepoint [1] 298205 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [1] 323485 0
Self-reported aerobic physical activity levels: measured using a modified version of the Godin Leisure-Time Exercise Questionnaire (Godin and Shephard, 1985).
Timepoint [1] 323485 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [2] 323486 0
Self-reported resistance training levels: measured using a modified version of the Godin Leisure-Time Exercise Questionnaire (Godin and Shephard, 1985).
Timepoint [2] 323486 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [3] 323487 0
Sedentary behaviour: measured using the 1-item scale from the 45 and UP Study Questionnaire (Ding et al, 2014).
Timepoint [3] 323487 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [4] 323488 0
Fasting blood sugar: measured using a fasting blood test.
Timepoint [4] 323488 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [5] 323489 0
Glycaemic control (HbA1C): measured using a fasting blood test.
Timepoint [5] 323489 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [6] 323490 0
Blood Lipids (high density lipoproteins, low density lipoproteins, triglycerides) measured using a fasting blood test.
Timepoint [6] 323490 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [7] 323491 0
Body mass index (BMI): height and weight will be measured using a digital scale and stadiometer. The standard equation (weight[kg]/height[m]2) will be used to calculate BMI.
Timepoint [7] 323491 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [8] 323492 0
Blood pressure: measured using a digital sphygmomanometer with a self-closing brachial cuff.
Timepoint [8] 323492 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [9] 323493 0
Waist measurement: measured using a non-extensible steel tape.
Timepoint [9] 323493 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [10] 323494 0
Intention: measured using the 3-item scale from The Theory of Planned Behaviour (Ajzen, 1991).
Timepoint [10] 323494 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [11] 323495 0
Stage of behaviour change: measured using a 1-item scale assessing stages of change from the Transtheoretical Model of Health Behaviour Change (Prochaska and Velicer, 1997).
Timepoint [11] 323495 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [12] 323496 0
Implementation intention: measured using a 7-item scale adapted from the Gollwitzer’s principle of implementation intentions -Plotnikoff et al, 2008).
Timepoint [12] 323496 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [13] 323497 0
Self-efficacy: (measured using a 10-item scale (from a 13-item scale) adapted for physical activity (Plotnikoff et al, 2008).
Timepoint [13] 323497 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [14] 323498 0
Recovery self-efficacy:(measured using a 3-item scale adapted for physical activity (Lusczynska and Schwarzer, 2003).
Timepoint [14] 323498 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [15] 323499 0
Outcome expectancies:(measured using a 12-item scale adapted for physical activity (Lusczynska and Schwarzer, 2003; Plotnikoff et al, 2001).
Timepoint [15] 323499 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [16] 323500 0
Risk perception related to type 2 diabetes: measured using a 3-item scale (Plotnikoff et al 2010).
Timepoint [16] 323500 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [17] 323501 0
Risk perception (general health risk): measured using a 6-item scale (Renner and Schwarzer, 2005).
Timepoint [17] 323501 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [18] 323502 0
Risk perception (general health severity): measured using a 6-item scale (Renner and Schwarzer, 2005).
Timepoint [18] 323502 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [19] 323503 0
Social support: measured using a 2-item scale (Courneya et al, 2000).
Timepoint [19] 323503 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [20] 323504 0
Perceived environment: measured using a 7-item scale (Sallis et al, 2010).
Timepoint [20] 323504 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [21] 323505 0
Nature relatedness: measured using the short form, 6-item version of the Nature Relatedness Scale (Nisbet and Zelenski, 2013).
Timepoint [21] 323505 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [22] 323506 0
Health outcomes: measured using 4 items from the original 5-item version of the EuroQol-5D (Group, 1990).
Timepoint [22] 323506 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [23] 323507 0
Rate of depression: measured using the 9-item Patient Health Questionnaire (PHQ-9) (Kroenke, Spitzer and Williams, 2001).
Timepoint [23] 323507 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [24] 323508 0
Rate of anxiety: measured using the 7-item Generalised Anxiety Disorder Questionnaire (GAD-7) (Spitzer et al 2006).
Timepoint [24] 323508 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [25] 323509 0
Quality of Life: measured using a 12-item scale, the short form-12 Health Survey (SF-12) (Ware, Kosinski and Keller, 1996).
Timepoint [25] 323509 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [26] 323510 0
Diet: measured using 11 items from the original 120-item Australian Eating Survey for Adults (Collins et al 2014).
Timepoint [26] 323510 0
Baseline, 3 months, 9 months, 18 months
Secondary outcome [27] 324504 0
Teaching self-efficacy: measured using an adapted 9-item scale (Martin and Kulinna, 2004; Tschannen-Moran and Woolfolk Hoy, 2001).
Timepoint [27] 324504 0
Baseline, 3 months, 9 months, 18 months

Eligibility
Key inclusion criteria
To be eligible to participate in the study, individuals are to be:
* 18 years of age or older;
* Currently diagnosed with type 2 diabetes (HbA1c >7.0) or 'at risk’ of developing type 2 diabetes (as assessed by the 10-item Australian type 2 Diabetes Risk Assessment Tool) (Australian Government, 2010; Aguiar, et al., 2015);
* Not currently meeting the Australian physical activity guidelines (determined by the validated Godin Leisure Time Questionnaire) (Godin, et al., 1985);
* A teacher (with a valid teaching qualification); and
* Prepared to complete the study protocol as detailed in the Participant Information Statement.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they:
* Have been achieving the Australian physical activity guidelines for at least the past 6 months (determined by the validated Godin Leisure Time Questionnaire) (Godin, et al., 1985);
* Are currently seeing an Exercise Specialist;
* Are currently enrolled in another study;
* Have a medical condition that might be adversely affected by increasing their physical activity (as determined by the Adult Pre-exercise Screening System (Exercise and Sports Science Australia, 2015) and/or their GP;
* Are unable to travel to the Newcastle University, Callaghan Campus (or Muswellbrook Hospital for rural participants) for assessments and appointments; and/or
* Do not have type 2 diabetes or are not 'at risk’ of developing type 2 diabetes (as assessed by the 10-item Australian type 2 Diabetes Risk Assessment Tool) (Australian Government, 2010; Aguiar, et al., 2015).

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)
Participants will be required to pass an eligibility and health screening questionnaire. Participants may be required to obtain a doctor’s clearance for certain health circumstances. If eligible, participants are required to read the study information statement and sign and return the consent form indicating they understand the requirement of their participation in the study.

Participants will be randomised at an individual level by an independent researcher who will not have any contact with participants during the study. Randomisation codes will be stored in a restricted computer folder.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The project will use a randomised controlled trial design with participants randomly allocated to one of the three study groups for the duration of the study. Participants will be matched, based on type 2 diabetes group (diagnosed with type 2 diabetes; 'at risk' of developing type 2 diabetes) and sex (male; female), then randomly allocated by an independent researcher to one of the three study groups using a computer-based random number producing algorithm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Wait-list control group will receive the intervention at study completion (9 months).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
12/04/2016
Date of last participant enrolment
Anticipated
23/09/2016
Actual
28/09/2016
Date of last data collection
Anticipated
30/06/2018
Actual
Sample size
Target
100
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 293529 0
Charities/Societies/Foundations
Name [1] 293529 0
Teachers' Health Foundation
Country [1] 293529 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive
Callaghan NSW 2308
Country
Australia
Secondary sponsor category [1] 293158 0
None
Name [1] 293158 0
Address [1] 293158 0
Country [1] 293158 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294965 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 294965 0
Ethics committee country [1] 294965 0
Australia
Date submitted for ethics approval [1] 294965 0
30/10/2015
Approval date [1] 294965 0
20/01/2016
Ethics approval number [1] 294965 0
H-2015-0417

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

Contacts
Principal investigator
Name 65654 0
Prof Ronald Plotnikoff
Address 65654 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive
Callaghan NSW 2308
Country 65654 0
Australia
Phone 65654 0
+61 2 4985 4465
Fax 65654 0
Email 65654 0
[email protected]
Contact person for public queries
Name 65655 0
Ronald Plotnikoff
Address 65655 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive
Callaghan NSW 2308
Country 65655 0
Australia
Phone 65655 0
+61 2 4985 4465
Fax 65655 0
Email 65655 0
[email protected]
Contact person for scientific queries
Name 65656 0
Ronald Plotnikoff
Address 65656 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive
Callaghan NSW 2308
Country 65656 0
Australia
Phone 65656 0
+61 2 4985 4465
Fax 65656 0
Email 65656 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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Conference abstractNo 370649-(Uploaded-11-04-2019-13-46-19)-Other results publication.pdf

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePreliminary efficacy and feasibility of referral to exercise specialists, psychologists and provision of a technology-based behavior change support package to promote physical activity in school teachers 'at risk' of, or diagnosed with, type 2 diabetes: The 'SMART Health' Pilot Study Protocol.2019https://dx.doi.org/10.1016/j.cct.2019.01.007
N.B. These documents automatically identified may not have been verified by the study sponsor.