Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001030763
Ethics application status
Approved
Date submitted
12/09/2013
Date registered
16/09/2013
Date last updated
12/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of Smartphone Applications For Improving Physical Fitness - AIMFIT
Scientific title
Effectiveness of smartphone applications for improving physical activity and physical fitness in youth aged 14-17 years: a three arm randomised controlled trial
Secondary ID [1] 283206 0
none
Universal Trial Number (UTN)
U1111-1147-9524
Trial acronym
AIMFIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical activity and sedentary behaviour 290066 0
Condition category
Condition code
Public Health 290448 290448 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be randomised to one of three conditions: 1) immersive application, consisting of a training program combined with an immersing story delivered via headphones, 2) non-immersive application, consisting of the training program only delivered via headphones, or 3) usual care, where participants will be asked to continue with their usual physical activities. The applications will be installed on participants’ iPod touch (Registered Trademark) or smartphones and will consist of an 8 week training programme (approximately 25 workouts, 3 per week, with a 35 minutes duration each) designed to improve their fitness and run 5km. An app diary/log will be used by participants to self-report the dates and time they use the app.
Intervention code [1] 287931 0
Lifestyle
Intervention code [2] 287945 0
Behaviour
Comparator / control treatment
Participants randomised to the usual care arm will be asked to continue with their usual physical activities for the duration of the study. The applications will be added to their smartphones/ipods at the end of the trial.
Control group
Active

Outcomes
Primary outcome [1] 290472 0
Between-groups difference in change in the completion time (i.e. in minutes and seconds) of the 1mile/1.6 Km run/walk test.
Timepoint [1] 290472 0
Baseline and post-invervention (8 weeks).
Secondary outcome [1] 304577 0
1 mile/1.6 km run/walk test, a cardiorespiratory fitness field test to measure physical fitness. A prediction equation developed by Cureton and colleagues will be used to estimate VO2Max expressed in ml/kg/min.
Timepoint [1] 304577 0
Baseline and post-invervention (8 weeks).
Secondary outcome [2] 304578 0
Physical Activity Questionnaire for Adolescents score (self-report physical activity levels)
Timepoint [2] 304578 0
Baseline and post-intervention (8 weeks).
Secondary outcome [3] 304579 0
Average daily time spent in light to vigorous activities (minutes) as measured via accelerometry
Timepoint [3] 304579 0
Baseline and post-intervention (8 weeks).
Secondary outcome [4] 304580 0
Average time spent using the app (times/week) (self-report)
Timepoint [4] 304580 0
Baseline and post-intervention (8 weeks).
Secondary outcome [5] 304590 0
Physical Activity Self-Efficacy Scale (PASES)
Timepoint [5] 304590 0
Baseline and post-intervention (8 weeks).
Secondary outcome [6] 304591 0
Physical Activity Enjoyment Scale (PACES)
Timepoint [6] 304591 0
Baseline and post-intervention (8 weeks).
Secondary outcome [7] 304592 0
Psychological Need Satisfaction in Exercise Scale (PNSE)
Timepoint [7] 304592 0
Baseline and post-intervention (8 weeks).
Secondary outcome [8] 304593 0
Acceptability and usability of the apps (survey)
Timepoint [8] 304593 0
Post-intervention

Eligibility
Key inclusion criteria
1. Be aged 14 to 17 years
2. Live within the greater Auckland area
3. Own an iPod touch or a smartphone (iPhone - Registered Trademark or Android - Registered Trademark)
4. Be able to perform physical activities
5. Not meet the NZ physical activity recommendations
6. Be able to provide written informed consent to participate in the study
7. Speak and understand English
Minimum age
14 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Medical condition which may limit ability to exercise safely
2. Downloaded/used the applications
3. Unable to understand and/or comply with the study protocol

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’ eligibility will be ascertained through telephone screening. Eligible participants will read and sign a consent form and attend a baseline measurement session, followed by accelerometer delivery. Participants will be allocated to the respective group using opaque envelopes (for concealment), once they return their accelerometer at a second session.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be stratified on sex. The within-group randomisation assignment will be previously generated by a statistician using a computer algorithm.
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
Normative data (The President's Challenge Program, 2013) with percentile scores based on age and test scores for the one mile/1.6 Km run/walk test indicate an average time of approximately 10 minutes for adolescents aged 14-17 in the 25th percentile to complete this test. An improvement in the completion time of this distance equivalent to a shift from the 25th to 50th percentile corresponds to an average of approximately less 78 seconds (standard deviation = 11 seconds) to complete the distance. Based on these data, a sample size of 14 adolescents per group (42 in total) will provide at least 80% power at 5% level of significance (two-sided) to detect a 16 seconds difference in change in running time from baseline between the two groups at the end of the running program, assuming a standard deviation of 15 seconds. Due to an expected 20% loss to follow-up a total sample size of 51 participants will be sought. All statistical tests will be two-tailed and a 5% significance level maintained throughout the analyses. Baseline characteristics will be summarised using descriptive statistics. Continuous variables will be described as numbers of observed and missing values, mean, standard deviation, median, minimum and maximum. Categorical variables will be described as frequencies and percentages. Results will be presented for each of the treatment groups as well as overall. Outcome evaluation will be performed on the principle of intention to treat (ITT), using data collected from all randomised participants. Analysis of covariance (ANCOVA) regression model will be used to evaluate the main exposure effect on the primary outcome between groups, adjusting for its baseline measure, important demographics and other potential confounding factors (if they are statistically significant at 5% level). A similar approach will be used for secondary outcome measures.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/09/2013
Actual
10/10/2013
Date of last participant enrolment
Anticipated
1/03/2014
Actual
20/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
51
Accrual to date
Final
51
Recruitment outside Australia
Country [1] 5408 0
New Zealand
State/province [1] 5408 0
Auckland

Funding & Sponsors
Funding source category [1] 287954 0
University
Name [1] 287954 0
National Institute for Health Innovation, University of Auckland
Country [1] 287954 0
New Zealand
Primary sponsor type
Individual
Name
Artur Direito
Address
National Institute for Health Innovation
University of Auckland
Private Bag 92019, Auckland Mailing Centre
Auckland, 1142
Country
New Zealand
Secondary sponsor category [1] 286672 0
Individual
Name [1] 286672 0
Ralph Maddison
Address [1] 286672 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019, Auckland Mailing Centre
Auckland, 1142
Country [1] 286672 0
New Zealand
Secondary sponsor category [2] 286675 0
Individual
Name [2] 286675 0
Robyn Whittaker
Address [2] 286675 0
National Institute for Health Innovation
University of Auckland
Private Bag 92019, Auckland Mailing Centre
Auckland, 1142
Country [2] 286675 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289881 0
The University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 289881 0
Ethics committee country [1] 289881 0
New Zealand
Date submitted for ethics approval [1] 289881 0
09/07/2013
Approval date [1] 289881 0
29/08/2013
Ethics approval number [1] 289881 0

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

Contacts
Principal investigator
Name 42894 0
Dr Ralph Maddison
Address 42894 0
National Institute for Health Innovation
University of Auckland Private Bag 92019
Auckland Mailing Centre
Auckland, 1142
Country 42894 0
New Zealand
Phone 42894 0
+64 9 3737 599 ext 84767
Fax 42894 0
Email 42894 0
[email protected]
Contact person for public queries
Name 42895 0
Artur Direito
Address 42895 0
National Institute for Health Innovation
University of Auckland Private Bag 92019
Auckland Mailing Centre
Auckland, 1142
Country 42895 0
New Zealand
Phone 42895 0
+64 9 3737 599 ext 85285
Fax 42895 0
Email 42895 0
[email protected]
Contact person for scientific queries
Name 42896 0
Ralph Maddison
Address 42896 0
National Institute for Health Innovation
University of Auckland Private Bag 92019
Auckland Mailing Centre
Auckland, 1142
Country 42896 0
New Zealand
Phone 42896 0
+64 9 3737 599 ext 84767
Fax 42896 0
Email 42896 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
EmbaseApps for IMproving FITness and Increasing Physical Activity Among Young People: The AIMFIT Pragmatic Randomized Controlled Trial.2015https://dx.doi.org/10.2196/jmir.4568
EmbaseSmartphone apps to improve fitness and increase physical activity among young people: protocol of the Apps for IMproving FITness (AIMFIT) randomized controlled trial.2015https://dx.doi.org/10.1186/s12889-015-1968-y
N.B. These documents automatically identified may not have been verified by the study sponsor.