Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000990527
Ethics application status
Approved
Date submitted
20/08/2015
Date registered
22/09/2015
Date last updated
4/04/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The community-based physical activity study for adults with type 2 diabetes, at high risk of Type 2 diabetes or overweight /obese.
Scientific title
Integrating Smartphone Technology, Social Support and the Outdoor Physical Environment to Promote Physical Activity among Adults diagnosed with Type 2 Diabetes, at High Risk of Type 2 Diabetes or Overweight /Obese: The Pilot Randomised Controlled Trial of the eCoFit.
Secondary ID [1] 286694 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes


 295048 0
High risk of Type 2 Diabetes 296032 0
Overweight 296033 0
Obesity 296034 0
Physical inactivity 296035 0
Condition category
Condition code
Public Health 295302 295302 0 0
Health promotion/education
Diet and Nutrition 296333 296333 0 0
Obesity
Metabolic and Endocrine 296380 296380 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this pilot randomized controlled trial is to develop, implement and evaluate a community-based physical activity intervention to improve aerobic and muscular fitness among adults diagnosed with Type 2 Diabetes, at high risk of Type 2 Diabetes or overweight /obese.

The 20-week multi-component intervention integrates the outdoor physical environment and smartphone application (App) technology. The intervention components include:

1) Five 90 minute group sessions which includes a 60 minute group outdoor training session with a qualified personal trainer and a 30 minute cognitive mentoring session with a clinical psychologist. Weeks 1 - 10; 1 session every 2 weeks.
a) Group outdoor training sessions with a qualified personal trainer: Participants will be educated on and participate in sessions using the outdoor physical environment (e.g. parks, benches) to increase aerobic and resistance training physical activity. The sessions involve 50% of aerobic training and 50% of resistance training [moderate-to-vigorous intensity (equal to or greater than 3 METs)].
b) Cognitive group mentoring sessions with a clinical psychologist: Participants will be educated on strategies to overcome barriers, increase their motivation for and adherence to physical activity.

Adherence to sessions will be monitored using a log of session attendance for each session.

2) "eCoFit Smartphone App". Weeks 1 to 20. The App, which will be specifically tailored to the study location, will include:
a) A description of where and how to use the outdoor physical environment to be more physically active. It includes pictures and instructions regarding how to use the outdoor physical environment (e.g., park benches) to perform various aerobic and resistance training exercises;
b) A standardized “eCoFit Challenge” in locations in the Newcastle Region, which involves a combination of 3km of aerobic activity and 2 sets of 6 resistance training activities. Participants will be able to see a map of the course indicating what activities are performed where and how to perform the exercises correctly on the course. It also has the option to select the level of difficulty (6 levels). The App will track the time it took participants to complete the “eCoFit Challenge” course and provides participants with a results table and progress chart;
c) “Indoor Challenges” which are resistance and aerobic training sessions that participants can complete at home with no equipment to provide an option for inclement weather (i.e., rain or heat).
d) A function to set weekly physical activity goals and self-monitor their progress;
e) “FitMind Challenges” which involve short tasks to increase motivation, overcome barriers and develop positive physical activity behaviours; and
f) Links to social media.

Participants will have unlimited access to all of App`s features. It is recommended that participants do at least 3 "eCoFit Challenges" per week.

The primary and secondary timepoint of the study is 10-weeks and 20-weeks respectively.
Intervention code [1] 291843 0
Behaviour
Intervention code [2] 292702 0
Lifestyle
Intervention code [3] 292703 0
Prevention
Comparator / control treatment
Wait-list control. Participants in the control group will receive standard treatment (i.e. follow their T2D management procedures as specified by their GP) during the intervention period and will receive the intervention after the 20-week follow-up assessments.
Control group
Active

Outcomes
Primary outcome [1] 295040 0
Aerobic fitness: assessed using the single stage submaximal treadmill walking test (Ebbeling et al., 1991).
Timepoint [1] 295040 0
Baseline, 10-weeks and 20-weeks
Primary outcome [2] 295837 0
Lower body muscular strength: assessed using the chair stand test (Rikli & Jones, 2013).
Timepoint [2] 295837 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [1] 314652 0
Physical activity: objectively measured physical activity will be assessed using pedometers (7 consecutive days wear time) and self-reported aerobic and resistance training physical activity will be assessed using specific items from the Godin Leisure-Time Exercise Questionnaire (Godin & Shephard, 1985).
Timepoint [1] 314652 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [2] 316633 0
Upper body muscular strength: assessed using the arm curl test (Rikli & Jones, 2013).
Timepoint [2] 316633 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [3] 316634 0
Functional mobility: assessed using the Timed Up and Go test (Podsiadlo & Richardson, 1991).
Timepoint [3] 316634 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [4] 316635 0
Body mass index: weight and height will be measured using a portable digital scale and stadiometer. Body mass index will be determined using the standard method (weight [kg] / height [m]2).
Timepoint [4] 316635 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [5] 316636 0
Waist circumference: measured using a non-extensible steel tape.
Timepoint [5] 316636 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [6] 316637 0
Blood pressure: measured using a standard sphygmomanometer with brachial cuff.
Timepoint [6] 316637 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [7] 316638 0
Stages of behavior change, using a validated algorithm assessing stages of the Transtheoretical Model (TTM) to determine the Health Action Process Approach Model (HAPA) stages
Timepoint [7] 316638 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [8] 316639 0
Intention, assessed using a validated measure the Health Action Process Approach Model (HAPA; Schwarzer, 2007)
Timepoint [8] 316639 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [9] 316640 0
Implementation intention assessed using a validated measure of the Social Cognitive Theory (SCT; Bandura 1997)
Timepoint [9] 316640 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [10] 316641 0
Self-efficacy a validated measure of the SCT (Bandura, 1997), Theory of Planned Behaviour (Ajzen, 1991), TTM (Prochaska, 1992);
Timepoint [10] 316641 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [11] 316642 0
Motivational Self-Efficacy assessed using a validated measure of the HAPA (Schwarzer, 2007)
Timepoint [11] 316642 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [12] 316643 0
Recovery Self-Efficacy assessed using a validated measure of the HAPA (Schwarzer, 2007)
Timepoint [12] 316643 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [13] 316644 0
Outcome expectancies assessed using a validated measure of the SCT (Bandura, 1997) and HAPA (Schwarzer, 2007)
Timepoint [13] 316644 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [14] 316645 0
Risk Perception assessed using a validated measure of the PMT (Rogers, 1983) and HAPA (Schwarzer, 2007)
Timepoint [14] 316645 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [15] 316646 0
Perceived Environment assessed using Perceived Environment 7 item scale
Timepoint [15] 316646 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [16] 316647 0
Health survey, measured using SF-12 (RAND-12)
Timepoint [16] 316647 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [17] 316648 0
Health outcome, measured using EQ-5D
Timepoint [17] 316648 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [18] 316649 0
Social Support assessed using Social Support 2 item scale
Timepoint [18] 316649 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [19] 316650 0
Perceived insufficient sleep assessed using item from the Behavioral Risk Factor Surveillance System (BRFSS) survey.
Timepoint [19] 316650 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [20] 316651 0
Sedentary behavior, assessed using 1 item from the 45 and UP Study Questionnaire
Timepoint [20] 316651 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [21] 316652 0
Nature relatedness measured by validated short-form version of the nature relatedness scale (NR-6)
Timepoint [21] 316652 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [22] 316653 0
The rate of Depression using the Patient Health Questionnaire (PHQ-9)
Timepoint [22] 316653 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [23] 316654 0
The rate of Anxiety, using the Generalized Anxiety Disorder 7-item (GAD-7)
Timepoint [23] 316654 0
Baseline, 10-weeks and 20-weeks
Secondary outcome [24] 316655 0
Implicit attitude toward physical activity, using modified version of the Implicit Association Test (IAT)
Timepoint [24] 316655 0
Baseline, 10-weeks and 20-weeks

Eligibility
Key inclusion criteria
Eligible participants will be18 to 75 years of age; diagnosed with Type 2 Diabetes (HbA1c greater than 7.0) or at high risk of Type 2 Diabetes (equal to or greater than 12 points on the AUSDRISK (Australian Government, 2010)) or overweight or obese (BMI equal to or greater than 25 and less than 40 kg/m2); not currently meeting the Australian physical activity guidelines as assessed by the Godin Leisure-Time Exercise Questionnaire (Godin & Shephard, 1985); passed the Adult Pre-exercise Screening System (Exercise and Sports Science Australia, 2011 or permission from GP); and own a smartphone.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they 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, 2011) or their GP; currently participating in an alternative physical activity program; intending to participate in other physical activity programs during the study period; or not available for assessment sessions

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



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/06/2015
Actual
11/06/2015
Date of last participant enrolment
Anticipated
7/07/2015
Actual
10/07/2015
Date of last data collection
Anticipated
Actual
20/12/2015
Sample size
Target
90
Accrual to date
Final
84
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291369 0
Government body
Name [1] 291369 0
Hunter Medical Research Institute
Country [1] 291369 0
Australia
Funding source category [2] 291370 0
University
Name [2] 291370 0
The University of Newcastle
Country [2] 291370 0
Australia
Primary sponsor type
Hospital
Name
Hunter Medical Research Institute
Address
1 Kookaburra Circuit
New Lambton Heights NSW 2305
Country
Australia
Secondary sponsor category [1] 290049 0
None
Name [1] 290049 0
Address [1] 290049 0
Country [1] 290049 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292929 0
The University of Newcastle Human Research Ethics Committee (HREC)
Ethics committee address [1] 292929 0
The University of Newcastle
Callaghan NSW 2308
Ethics committee country [1] 292929 0
Australia
Date submitted for ethics approval [1] 292929 0
Approval date [1] 292929 0
26/05/2015
Ethics approval number [1] 292929 0

Summary
Brief summary
The aim of this randomised controlled trial is to develop, implement and evaluate a community-based intervention to promote physical activity among adults diagnosed with Type 2 Diabetes, at high risk of Type 2 Diabetes or overweight /obese. The 20-week intervention will include five sessions with a qualified personal trainer and a smartphone App. Aerobic fitness, muscular strength, physical activity, functional mobility, BMI, waist circumference, blood pressure, and cognitive variables will be assessed. Assessment will be conducted at baseline, 10-weeks and 20-weeks.
Trial website
Trial related presentations / publications
Wilczynska M, Lubans DR, Cohen KE, Smith JJ, Robards SL, Plotnikoff RC. Rationale and study protocol for the ‘eCoFit’ randomized controlled trial: Integrating smartphone technology, social support and the outdoor physical environment to improve health-related fitness among adults at risk of, or diagnosed with, Type 2 Diabetes. . Contemp Clin Trials. 2016;49:116-125.
Public notes

Contacts
Principal investigator
Name 57206 0
Prof Ronald Plotnikoff
Address 57206 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive Callaghan NSW 2308
Country 57206 0
Australia
Phone 57206 0
+61 2 4985 4465
Fax 57206 0
Email 57206 0
[email protected]
Contact person for public queries
Name 57207 0
Prof Ronald Plotnikoff
Address 57207 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive Callaghan NSW 2308
Country 57207 0
Australia
Phone 57207 0
+61 2 4985 4465
Fax 57207 0
Email 57207 0
[email protected]
Contact person for scientific queries
Name 57208 0
Prof Ronald Plotnikoff
Address 57208 0
Priority Research Centre for Physical Activity and Nutrition
University of Newcastle
University Drive Callaghan NSW 2308
Country 57208 0
Australia
Phone 57208 0
+61 2 4985 4465
Fax 57208 0
Email 57208 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
EmbaseIntegrating smartphone technology, social support and the outdoor physical environment to improve fitness among adults at risk of, or diagnosed with, Type 2 Diabetes: Findings from the 'eCoFit' randomized controlled trial.2017https://dx.doi.org/10.1016/j.ypmed.2017.08.027
EmbaseRationale and study protocol for the 'eCoFit' randomized controlled trial: Integrating smartphone technology, social support and the outdoor physical environment to improve health-related fitness among adults at risk of, or diagnosed with, Type 2 Diabetes.2016https://dx.doi.org/10.1016/j.cct.2016.06.013
N.B. These documents automatically identified may not have been verified by the study sponsor.