Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001349437
Ethics application status
Approved
Date submitted
26/08/2016
Date registered
27/09/2016
Date last updated
12/12/2018
Date data sharing statement initially provided
12/12/2018
Date results information initially provided
12/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The Mindfulness App Trial for Weight, Weight related Behaviours, and Stress in University Students.
Scientific title
The Mindfulness App Trial for Weight, Weight related Behaviours, and Stress in University Students.
Secondary ID [1] 290012 0
Nil
Universal Trial Number (UTN)
U1111-1186-8480
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stress 300029 0
physical activity 300146 0
eating behaviours 300147 0
Condition category
Condition code
Public Health 299922 299922 0 0
Health promotion/education
Diet and Nutrition 299923 299923 0 0
Obesity
Mental Health 299924 299924 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mobile mindfulness-based app intervention for weight loss using mindfulness based stress reduction techniques (e.g body scan, Hatha Yoga, walking and sitting meditation, and breathing exercises) and mindful eating techniques. The app will also have basic educational information on basic dietary and physical activity guideline information from The WHO guidelines on Physical activity and dietary intake.The app will be compatible with iPhone and android. The mobile app will enable mindful eating and minduflness-based stress reduction text messages to be sent as push notifications. It will further have written educational information, mindfulness meditation and yoga videos, meditation audios, photos that inspire mindfulness, and an electronic diary for self-monitoring of mindfulness activities. Push notifications will also be sent at a frequency of 1-2 per week. To ensure students are motivated, they will receive text messages during the final 3 weeks of the study (1) per week to motivate them extra to use the app beyond the push notifications near the high stress busy exam period.
Mode of Delivery: by Mobile Phone
Duration: 11 weeks
Location: University of Queensland St Lucia and Herston Campuses
Post intervention focus groups will be conducted to learn about experiences with the app and any attitudinal changes towards meditation and a healthy lifestyle.
Intervention code [1] 295719 0
Treatment: Devices
Intervention code [2] 295733 0
Lifestyle
Intervention code [3] 295734 0
Behaviour
Comparator / control treatment
The control group will receive an electronic self-monitoring diary table of dietary intake and physical as a word document which may be printed. There will also be a link at the top of the table as a reference to the WHO's diet and physical activity fact sheets.
Control group
Active

Outcomes
Primary outcome [1] 299400 0
Weight loss (kg) measured using a digital scale BMI (measured as kg/m2)
Timepoint [1] 299400 0
3 months
Primary outcome [2] 299401 0
Eating Behaviours Using the 3 factor Eating Behaviour Questionnaire were used . This is not a change.
Timepoint [2] 299401 0
3 months
Primary outcome [3] 299402 0
Mindfulness was assesed using the Cognitive and Affective Mindfulness Questionnaire (CAMRs ).
Timepoint [3] 299402 0
3 months
Secondary outcome [1] 327085 0
stress using the Perceived Stress Scale (PSS)
Timepoint [1] 327085 0
3 months
Secondary outcome [2] 354923 0
Physical activity using the IPAC (short)
Timepoint [2] 354923 0
11 weeks
Secondary outcome [3] 354924 0
Mindful Eating using the Mindful Eating Questionnaire MEQ
Timepoint [3] 354924 0
11 weeks

Eligibility
Key inclusion criteria
healthy undergraduate students 18-25 years of age owning a smartphone with a desire to lose weight. All healthy students wishing to lose weight are eligible , they do not have to meet the cut offs for overweight and obese (BMI >25 kg/m2 and >30 kg/m2).
Minimum age
18 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Students <18 years of age will be excluded and those >25 years of age.pregnant women will be excluded. This study is for healthy individuals. Students with any reported history of any serious pre-existing medical conditions will be excluded. This includes eating disorders, psychiatric illnesses, and any underlying reported history of physical illness where weight loss is contraindicated. Students with a BMI of 20 or less will be excluded.

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)
Yes, allocation will be concealed (central randomization by computer)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Students will be randomized to the intervention arm or control group using a computer generated random number sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
2 arm RCT
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analysis of covariance ANCOVA will be used to assess weight changes and weight related behaviours from baseline to follow-up between the intervention and control groups.

As this will be the first mobile mindfulness-based text message intervention for weight loss, there are no previous effect sizes that may give a precise same size calculation. However, an estimate was based on likely effects including related mHealth studies . Assuming a moderate effect size with alpha =0.05 and 80% power to detect a difference, a sample size of 58 would be required for 10% drop out and 66 would be required to account for 20% drop out. This trial will aim to recruit over 58 participants, with the aim of recruiting more to take into account a possibly weaker effect size (doubling).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2017
Actual
17/07/2017
Date of last participant enrolment
Anticipated
14/08/2017
Actual
14/08/2017
Date of last data collection
Anticipated
19/08/2017
Actual
14/11/2017
Sample size
Target
58
Accrual to date
Final
90
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 294386 0
University
Name [1] 294386 0
University of Queensland
Country [1] 294386 0
Australia
Funding source category [2] 294387 0
Government body
Name [2] 294387 0
International Postgraduate Research Scholarship (Australian Commonwealth government scholarship)
Country [2] 294387 0
Australia
Funding source category [3] 294453 0
University
Name [3] 294453 0
UQ Centennial Scholarship
Country [3] 294453 0
Australia
Primary sponsor type
University
Name
University of Queensland (School of Medicine)
Address
University of Queensland, School of Medicine
Mayne Medical School
288 Herston road
Queensland 4006
Australia
Country
Australia
Secondary sponsor category [1] 293319 0
Other Collaborative groups
Name [1] 293319 0
Centres for Online Health and Psychiatry
Address [1] 293319 0
Centre for Online Health
The University of Queensland
Building 33
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country [1] 293319 0
Australia
Secondary sponsor category [2] 293330 0
University
Name [2] 293330 0
University of Queensland Graduate School
Address [2] 293330 0
UQ grad school
61 John Hines Building
St Lucia campus, Queensland
4072 Australia
Country [2] 293330 0
Australia
Other collaborator category [1] 279204 0
Other Collaborative groups
Name [1] 279204 0
Department of Psychiatry University of Queensland
Address [1] 279204 0
Department of Psychiatry
Herston Royal Brisbane and Women's Hospital
K floor
Herston Queensland 4029
Country [1] 279204 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295809 0
UQ HREC
Ethics committee address [1] 295809 0
University of Queensland Human Research Ethics Committee.
Cumbrae-Stewart Building #72, The University of Queensland St Lucia, QLD 4072.
Ethics committee country [1] 295809 0
Australia
Date submitted for ethics approval [1] 295809 0
03/10/2016
Approval date [1] 295809 0
07/07/2017
Ethics approval number [1] 295809 0

Summary
Brief summary
The primary purpose of the study is to develop and evaluate the effectiveness of a mindfulness app for weight loss and changing weight related behaviors (diet/physical activity) in college students. This research will aim to determine if a mindfulness app is feasible, acceptable, and effective for weight loss and weight related behaviors than a standard control group receiving an information leaflet on diet/physical activity. The research will also aim to determine if the intervention reduces stress as a secondary outcome of interest. It is anticipated that the mindfulness app intervention will be more effective for improving these outcomes than the control.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68538 0
Ms Lynnette Nathalie Lyzwinski
Address 68538 0
The University of Queensland
Building 33
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country 68538 0
Australia
Phone 68538 0
+61 7 3176 8181
Fax 68538 0
Email 68538 0
[email protected]
Contact person for public queries
Name 68539 0
Ms Lynnette Nathalie Lyzwinski
Address 68539 0
The University of Queensland
Building 33
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country 68539 0
Australia
Phone 68539 0
+61 7 3176 8181
Fax 68539 0
Email 68539 0
[email protected]
Contact person for scientific queries
Name 68540 0
Ms Lynnette Nathalie Lyzwinski
Address 68540 0
The University of Queensland
Building 33
Princess Alexandra Hospital
Woolloongabba QLD 4102
Country 68540 0
Australia
Phone 68540 0
+61 7 3176 8181
Fax 68540 0
Email 68540 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Undecided as I am a student and this was part of my study research which means it will be with the University. I did not seek ethics approval to share the data with anyone outside of my research team and university.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
663Informed consent form    371370-(Uploaded-06-12-2018-18-49-25)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Under review in journals TBD.
Basic resultsNo 371370-(Uploaded-11-12-2018-18-02-26)-Basic results summary.docx
Plain language summaryNo A total of 90 students enrolled in the trial (45 w... [More Details]

Documents added automatically
No additional documents have been identified.