Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000868189
Ethics application status
Approved
Date submitted
22/05/2019
Date registered
19/06/2019
Date last updated
5/09/2019
Date data sharing statement initially provided
19/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrating Smartphone Technology and the Outdoor Built Environment to Promote Aerobic and Resistance-based Physical Activity in the General Population: The ecofit Randomised Controlled Trial
Scientific title
Rationale and study protocol for the ‘ecofit’ randomised controlled trial: Integrating Smartphone Technology, Social Support and the Outdoor Built Environment to Promote Community-based Aerobic and Resistance-based Physical Activity in the general adult population.
Secondary ID [1] 298308 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 312940 0
Condition category
Condition code
Public Health 311430 311430 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The ecofit is an innovative 9-month multi-component physical activity intervention study. The intervention aims to increase aerobic and resistance-based physical activity through the use of smartphone technology, social support and the outdoor built environment in the general population. The intervention targets individuals who do not meet the current aerobic and/or resistance-based physical activity guidelines in Newcastle and Lake Macquarie City Council areas, New South Wales (NSW), Australia.

The intervention incorporates:
- The ecofit smartphone app:
The app is comprised of multiple functions, including: Standardised workouts, Workout locations, Workout categories, Self-monitoring functions (These include, to set weekly workout goals, track workout history, track past work out goals and monitor progress), Exercise library, Resources (The resource folder include information regarding the physical, psychological and clinical benefits of aerobic and resistance-based physical activity and the current physical activity guidelines). These resources have been specifically designed for this study. It is not mandatory for participants to use all aspects of the app, i.e., accessing the resource folder is optional. Having the app usage data will allow us to monitor adherence to the intervention.

Standardised workouts: Each workout is composed of eight resistance-based exercises (i.e., two core, two upper body, two lower body, one chest and one back) that targets major muscle groups. Participants can choose between two types of workouts ('Fixed' or 'Trail-based'). At the ‘Fixed’ locations the equipment is clustered in one spot, whereas at the ‘Trail-based’ exercise location, the outdoor exercise equipment is located along a trail. Once the workout type has been chosen, participants will select between three types of training categories; ‘resistance only’, ‘resistance and aerobic’ or integrated resistance and aerobic’. The resistance only option consist of eight resistance-based exercises. While all exercises will cover the same body parts (i.e., two core, two upper body, two lower body, one chest and one back), the types of exercises may vary slight between parks depending on the availability of equipment. The ‘resistance and aerobic’ option consists of an added aerobic workout (i.e., run, jog or brisk walk) for 20 minutes upon completion of all the resistance-based exercises. The ‘integrated resistance and aerobic’ option alternates one resistance-based exercise with a short bout of aerobic activity (i.e., 60-second run). To allow for participant progress and targeting users of different fitness levels, the app has built in three different difficulty levels (i.e., beginner, intermediate, and experienced). For example, a beginner-level push-up is completed on the knees whereas an experience-level push-up is completed on the toes.

- 90 minute introductory group session run by an exercise physiologist:
The session will help to educate participants on: (1) how to perform correct techniques of the exercises included in the program; (2) how to access and use the ecofit app; (3) and provided with an app user guide. Participants will be encourage to do 2 or more app workouts per week, for the duration of the intervention.

Assessments are conducted at baseline, 3-months (primary time point) and 9-months (follow-up).

The intervention will be administered by an Exercise Specialist.

This study will generate novel findings regarding the effect of using smartphone technology, social support and the outdoor build environment to improve physical activity levels in the general population.
Intervention code [1] 314539 0
Behaviour
Intervention code [2] 314540 0
Lifestyle
Intervention code [3] 314624 0
Treatment: Other
Comparator / control treatment
Wait-list control group; intervention will be delivered after treatment for intervention group. They will be encouraged / instructed to go about their day as normal. No additional activities will be provided/required.
Control group
Active

Outcomes
Primary outcome [1] 320151 0
Upper body muscular fitness: Upper body muscular endurance will be measured using the validated 90 degree push-up test. Participants will be instructed to keep their body in a straight line from the toes to hips, and to the shoulders. One push-up repetition consists of lowering the body until the elbows bend 90 degrees and the upper arms are parallel to the floor, followed by pushing back up to the start position. The push-ups are done in time with a metronome, which is set at 40 beats per minute (20 push-ups per minute). The test assesses the maximum number of repetitions that can be performed correctly in rhythm without breaking form for more than two consecutive or non-consecutive push-ups.
Timepoint [1] 320151 0
baseline, 3 months (primary) and 9 months (follow-up)
Primary outcome [2] 320152 0
Lower body muscular fitness: Lower body muscular fitness will be measured using the validated sit-to-stand test which has recent norms for adults aged 18-80. The sit-to-stand test measures lower body muscular strength and endurance by the number of times the person can stand up and sit down on a regular chair in one minute.
Timepoint [2] 320152 0
baseline, 3 months (primary) and 9 months (follow-up)
Secondary outcome [1] 370718 0
Physical activity: Physical activity will be objectively measured using water proof Actigraph GT9X Link wrist-worn accelerometers. The Actigraph has shown acceptable validity and reliability compared to other commercially available activity monitors. The sum of daily minutes spent in moderate to vigorous physical activity will be monitored by the Actigraph and used to determine participants current physical activity levels. Each participant will be instructed about correct wear and fitting of the ActiGraph activity monitor during the baseline assessment and asked to wear the monitor on their non-dominant wrist for seven consecutive days. Participants will provided a log book to record resistance-based physical activity activities, and record times when the monitor was removed and physical activity undertaken.
Timepoint [1] 370718 0
baseline, 3 months and 9 months
Secondary outcome [2] 370719 0
Body composition: Body composition will be measured using the validated dual-energy x-ray absorptiometry (DXA). The GE Lunar Prodigy Scanner (Model part: Spellman, Lunar 8743) will be used to conduct the scans. Participants will lie on a scanner bed while scanning arms pass over their body measuring muscle and fat composition. The scan takes approximately six minutes to complete.
Timepoint [2] 370719 0
baseline, 3 months and 9 months
Secondary outcome [3] 370720 0
Aerobic fitness: Aerobic fitness will be measured using the validated YMCA step test. The step test measures cardiorespiratory fitness by step up and down a platform at the rate of 24 step-ups/minute for three consecutive minutes. Upon completion of the test, participants are to sit quietly for 1-minute. Participants performance level is determined by the recovery heart rate at the 1-minute mark post completion.
Timepoint [3] 370720 0
Baseline, 3-month and 9-month
Secondary outcome [4] 370721 0
Body mass index: Body mass index (BMI) will be calculated using the standard equation (weight [kg]/height[m]²). Weight is measured to the nearest 0.1 kilogram without shoes and in light clothing using a portable digital scale. Height is measured to the nearest 0.1 centimetre using a stadiometer. Individuals are classified as being within the healthy weight range if they have a BMI 18.5-24.9. BMI scores of less than 18.5 is classified as underweight, BMI scores of 25-29.9 is regarded as overweight and a BMI of 30 and over is categorised as obese.
Timepoint [4] 370721 0
Baseline, and 3 month only.
Secondary outcome [5] 370722 0
Self-report resistance-based physical activity: Self-reported resistance-based physical activity will be measured using a modified version of the validated Godin Leisure-Time questionnaire. The modification includes the average number of minutes per session, as well as adding an additional question regarding resistance training i.e., average times per week participating in resistance training.
Timepoint [5] 370722 0
Baseline, 3 month and 9 month
Secondary outcome [6] 370723 0
Active travel: Active travel will be measured using three active travel items/questions from the Global Physical Activity Questionnaire (GPAQ). Items include, “Do you walk or use a bicycle at least 10 minutes continuously to get to and from places, other than work”; “In a typical week, on how many days do you walk or bicycle for at least 10 minutes continuously to get to and from places, other than work?”; and “How much time in minutes and hours do you spend walking or cycling for travel on a typical day?”. These three questions all fall under the Active Travel banner.
Timepoint [6] 370723 0
Baseline, 3-month and 9-month
Secondary outcome [7] 370724 0
Self-reported happiness: Self-reported happiness will be measured by one question, “In the past month, have you felt happy”. Participants can choose from six response options ranging from “never” (1) to “all the time”. This question is from: Richards J, Jiang X, Kelly P, Chau J, Bauman A, Ding D. Don't worry, be happy: cross-sectional associations between physical activity and happiness in 15 European countries. BMC Public Health. 2015;15(1):53, DOI: 10.1186/s12889-015-1391-4.
Timepoint [7] 370724 0
Baseline, 3 month and 9 month
Secondary outcome [8] 370725 0
Depression, Stress and Anxiety: Mental health outcomes will be measured using a composite, validated self-assessment, the Depression, Anxiety and Stress Scale (DASS-21). DASS-21 is a 21-item self-report instrument designated to measure the severity of symptoms relating to depression, anxiety and stress. Each item is scored using a 4-point Likert-type scale, ranging from 0 (item did not apply to them at all) to 3 (item applied to them very much, or most of the time), to rate the extent to which participants experienced each state over the past week. For example, over the last week, “I have found it hard to wind down” (0 = not at all, 1 = some of the time, 2 = a good part of the time, 3 = most of the time). Scores are determined by calculating the sum of scores of the relevant items within each of the three scales.
Timepoint [8] 370725 0
Baseline, 3-month and 9-month
Secondary outcome [9] 371034 0
Self-report aerobic physical activity: Self-reported aerobic physical activity will be measured using a modified version of the validated Godin Leisure-Time questionnaire. The modification includes the average number of minutes per session, as well as adding an additional question regarding aerobic training i.e., average times per week participating in aerobic training.
Timepoint [9] 371034 0
Baseline, 3 month and 9 month

Eligibility
Key inclusion criteria
Participants aged 18-80
Access to a smartphone
Not meeting current aerobic and/or resistance-based physical activity guidelines
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Have a medical condition that might be adversely affected by increased physical activity
Currently participating in an alternative physical activity program
Intending to participate in other physical activity programs during the study period
Not available for assessment sessions

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)
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
Recruiting
Date of first participant enrolment
Anticipated
20/06/2019
Actual
28/08/2019
Date of last participant enrolment
Anticipated
1/04/2020
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
23
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302849 0
Government body
Name [1] 302849 0
National Health and Medical Research Council
Country [1] 302849 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University of Newcastle,
University Drive,
Callaghan, NSW, 2308.
Country
Australia
Secondary sponsor category [1] 302799 0
None
Name [1] 302799 0
Address [1] 302799 0
Country [1] 302799 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303425 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [1] 303425 0
University Drive, Callaghan
NSW 2308, Australia
Ethics committee country [1] 303425 0
Australia
Date submitted for ethics approval [1] 303425 0
Approval date [1] 303425 0
22/04/2018
Ethics approval number [1] 303425 0

Summary
Brief summary
The aim of this study is to investigate the effectiveness of ecofit, which is an innovative community-based multi-component physical activity intervention that promotes aerobic and resistance-based physical activity through smartphone technology, social support and recently installed outdoor exercise equipment in Newcastle area, NSW, Australia.

Participants in the intervention group will have access to the ecofit smartphone app, an introductory group session and up to 10 exercise locations, whereas the 'wait-list' control group only have access to the exercise locations. To assess the effectiveness of ecofit program, the intervention group will be compared to a 'wait-list' control group.

We will measure upper and lower body muscular fitness (co-primary outcomes) and a host of secondary outcomes at baseline, 3- and 9-months.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93634 0
Prof Ronald Plotnikoff
Address 93634 0
Priority Research Centre in Physical Activity and Nutrition
The University of Newcastle, Callaghan,
NSW, 2308, Australia
Country 93634 0
Australia
Phone 93634 0
+61 2 49854465
Fax 93634 0
Email 93634 0
[email protected]
Contact person for public queries
Name 93635 0
Prof Ronald Plotnikoff
Address 93635 0
Priority Research Centre in Physical Activity and Nutrition
The University of Newcastle, Callaghan,
NSW, 2308, Australia
Country 93635 0
Australia
Phone 93635 0
+61 2 49854465
Fax 93635 0
Email 93635 0
[email protected]
Contact person for scientific queries
Name 93636 0
Prof Ronald Plotnikoff
Address 93636 0
Priority Research Centre in Physical Activity and Nutrition
The University of Newcastle, Callaghan,
NSW, 2308, Australia
Country 93636 0
Australia
Phone 93636 0
+61 2 49854465
Fax 93636 0
Email 93636 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
EmbasemHealth to Support Outdoor Gym Resistance Training: The ecofit Effectiveness RCT.2023https://dx.doi.org/10.1016/j.amepre.2023.01.031
EmbaseValidity of muscular fitness self-assessments in the ecofit smartphone application: A correlation study.2022https://dx.doi.org/10.1371/journal.pone.0278374
EmbaseIntegrating smartphone technology, social support and the outdoor built environment to promote community-based aerobic and resistance-based physical activity: Rationale and study protocol for the 'ecofit' randomized controlled trial.2019https://dx.doi.org/10.1016/j.conctc.2019.100457
Dimensions AIAdherence to therapeutic exercise for lateral elbow tendinopathy – A scoping review2022https://doi.org/10.1016/j.jsams.2022.09.079
Dimensions AIA multi-component, community-based outdoor gym intervention: the ecofit effectiveness trial2022https://doi.org/10.1016/j.jsams.2022.09.078
Dimensions AIPlacebo gait retraining for use in knee osteoarthritis clinical trials does not change surrogate knee load measures: A randomized pilot study2022https://doi.org/10.1016/j.jsams.2022.09.080
N.B. These documents automatically identified may not have been verified by the study sponsor.