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Trial registered on ANZCTR
Registration number
ACTRN12618001189213
Ethics application status
Approved
Date submitted
4/07/2018
Date registered
17/07/2018
Date last updated
5/02/2021
Date data sharing statement initially provided
5/02/2021
Type of registration
Prospectively registered
Titles & IDs
Public title
Weight Management App for People Living with Chronic Illness
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Scientific title
Evaluating the Efficacy of a Body Weight Management Smartphone App for People Living with Chronic Illness: a Randomised Controlled Trial
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Secondary ID [1]
295430
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Not Applicable
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Universal Trial Number (UTN)
Not Applicable
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Trial acronym
Not Applicable
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Linked study record
Not Applicable
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Health condition
Health condition(s) or problem(s) studied:
Overweight
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Chronic illness
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Obese
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Condition category
Condition code
Cardiovascular
307614
307614
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0
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Other cardiovascular diseases
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Diet and Nutrition
307615
307615
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A pilot RCT of an interactive ‘Weight Management Wellness App’. 76 patients who have a diagnosis of chronic illness with BMI greater than or equal to 25 kg/m2 will be randomly allocated to intervention or control groups.
The intervention consists of a "Weight Management Wellness" app which is developed based on cognitive behavioural therapy (CBT) principles. It contains video, text information, podcast, weight tracker, mood tracker, daily activity tracker, daily questionnaires.
The CBT program offers four evidence-based psychological modules that users can complete via the app at their convenience. The program was designed by Canadian clinical psychologists who are on the project research team. The four modules in the CBT programs are: CBT model of overeating, Eating guidelines / Food records, Alternate pleasurable activities and Problem Solving. The videos in the app were recorded to cover each of the modules, and the podcasts have the same contents with the videos, so that users can listen to them when they don't have time to watch the videos.
The participants will be asked to access the app daily for "mood tracker", "daily activity tracker" and "daily questionnaire" components for 3 months, they will also be asked to complete the four CBT modules in the app for the first 6 weeks. Each module is expected to take between one to two hours over a week period to complete.
Participants adherence will be examined weekly by the research team using google analytics. Participants not engaging with the app for the week will be contacted by teephone or email to discuss any issues pertaining to adherence.
Phone and email support will be available as needed for the entire duration of the study.
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Intervention code [1]
301741
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Behaviour
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Comparator / control treatment
The intervention group accesses the Weight Management Wellness App after baseline survey, and technical support will be available as needed to participants. The control group will receive standrard health care from the clinics in the hospitial or managed by their GPs about their chronic condition, The control group can access the app after study completion.
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Control group
Active
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Outcomes
Primary outcome [1]
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Body weight
The body weight will be self-reported weekly by the participants in "Weight Tracker" component in the app
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Assessment method [1]
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Timepoint [1]
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Baseline, 6-weeks, 3-month (primary endpoint) and 6-months post-recruitment
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Secondary outcome [1]
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BMI calculated by research team based on self-reported weight and height by particpants
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Assessment method [1]
348965
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Timepoint [1]
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Baseline, 6-weeks, 3-month and 6-months post-recruitment
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Secondary outcome [2]
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Mood measured by Patient Health Questionnaire
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Assessment method [2]
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Timepoint [2]
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Baseline, 6-weeks, 3-month and 6-months post-recruitment
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Secondary outcome [3]
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Activities measured by Daily activity diary
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Assessment method [3]
349398
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Timepoint [3]
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Baseline, 6-weeks, 3-month and 6-months post-recruitment
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Secondary outcome [4]
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Quality of life measured by SF-12 questionnaire
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Assessment method [4]
349399
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Timepoint [4]
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Baseline, 6-weeks, 3-month and 6-months post-recruitment
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Eligibility
Key inclusion criteria
1) Have one or more chronic diseases, e.g. diabetes, asthma, cardiovascular disease and mental illness.
2) Considered as overweight or obese according to WHO definition: A person with a BMI of 30 or more is considered obese and a BMI equal to or more than 25 is considered overweight;
3) Aged 18 years or above;
4) Proficient in English;
5) Have access to iPhone, iPad or Android phone or tablet computer
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1) Self-report a diagnosis of severe mental illness
2) Currently pregnant or planning on becoming pregnant during the intervention.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potential participants will be screened to assess eligibility either face to face or over the phone. Eligible participants will then proceed to perform the baseline surveys, including demographic information, Patient Health Questionnaire (PHQ), and Short Form Survey (SF12) which assesses quality of life. Following the baseline assessment, participants will be randomly allocated to either the intervention or control group. The central randomization is done by computer program.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomization sequence will be determined using a computer program generated random number schedule.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Not applicable
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Thirty-eight participants per group (total n = 76) are required to provide 90% power (two-sided p<0.05) and medium effect size. Participants will be block randomized by BMI 25-30 and BMI >30 to ensure equal distribution of “overweight” and “obese” patients in two groups.
Descriptive statistics for the primary and secondary outcome variables will be calculated and analysed using SPSS. Qualitative data will be combined for the purposes of analysis.
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Recruitment
Recruitment status
Withdrawn
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
15/08/2018
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Actual
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Date of last participant enrolment
Anticipated
20/08/2019
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Actual
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Date of last data collection
Anticipated
28/02/2020
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Actual
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Sample size
Target
76
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Port Macquarie Base Hospital - Port Macquarie
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Recruitment postcode(s) [1]
23214
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2444 - Port Macquarie
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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Mid North Coast Local Health District Research Support Grant
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Address [1]
300016
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Morton Street
Port Macquarie NSW
2444
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Country [1]
300016
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Australia
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Primary sponsor type
Government body
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Name
Mid North Coast Local Health District
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Address
Morton Street
Port Macquarie NSW
2444
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
299409
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Address [1]
299409
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Country [1]
299409
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
300869
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Hunter New England Human Research Ethics Committee
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Ethics committee address [1]
300869
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Locked Bay No.1
New Lambton NSW
2305
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Ethics committee country [1]
300869
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Australia
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Date submitted for ethics approval [1]
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05/12/2017
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Approval date [1]
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07/02/2018
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Ethics approval number [1]
300869
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17/12/13/4.08
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Summary
Brief summary
The aims of the project is to examine:
1) the effect of a weight management smartphone application (app) for people living with chronic illnesses on participants’ body weight (primary outcome), Body Mass Index (BMI), activity level, mood and quality of life (secondary outcomes).
2) participants’ appraisal and perceived benefits of the app, and frequency of app use.
Project aims: To examine:
1) the effect of a weight management smartphone application (app) for people living with chronic illnesses on participants’ body weight (primary outcome), Body Mass Index (BMI), activity level, mood and quality of life (secondary outcomes).
2) participants’ appraisal and perceived benefits of the app, and frequency of app use.
Why is this study needed? Being overweight or obese are major risk factors for many chronic diseases, such as diabetes and cardiovascular diseases, and are dramatically on the rise in urban and rural settings. There are weight loss apps available, but few randomised controlled trials (RCTs) have been conducted to evaluate the effectiveness of these apps. Few apps adopted an evidence-based and theory-based approach in its development.
Method: A pilot RCT of an interactive ‘Weight Management Wellness App’. 76 patients who have a diagnosis of chronic illness with BMI greater than or equal to 25 kg/m2 will be randomly allocated to intervention or control groups. The app is developed based on cognitive behavioural therapy (CBT) principles. It contains video, text information, podcast, weight tracker, mood tracker, daily activity tracker, daily questionnaires and resources locator. Outcomes measured at baseline, 6-week, 3-months and 6-months, include: body weight, BMI, activity level, mood and quality of life.
Benefits and translation: This study generates reliable evidence using a rigorous RCT design to evaluate an app which contains unique feature – adopting principles of CBT in weight management. This study addresses current gap in information quality and lack of theory underpinning current weight management apps in app stores. The app could reach out to people living with chronic illness with weight management issues, and help reduce the weight- associated comorbidities, thus leading to an enhanced quality of life and minimise the long-term burden of chronic diseases on healthcare system.
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Trial website
Nill
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Trial related presentations / publications
Nill
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Public notes
Nill
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Contacts
Principal investigator
Name
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Prof Sally Chan
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Address
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School of Nursing and Midwifery
The University of Newcastle
University Drive
Callaghan NSW
2308
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Country
85098
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Australia
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Phone
85098
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+61 2 4921 6770
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Fax
85098
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Email
85098
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[email protected]
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Contact person for public queries
Name
85099
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Prof Sally Chan
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Address
85099
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School of Nursing and Midwifery
The University of Newcastle
University Drive
Callaghan NSW
2308
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Country
85099
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Australia
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Phone
85099
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+61 2 4921 6770
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Fax
85099
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Email
85099
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[email protected]
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Contact person for scientific queries
Name
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Prof Sally Chan
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Address
85100
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School of Nursing and Midwifery
The University of Newcastle
University Drive
Callaghan NSW
2308
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Country
85100
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Australia
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Phone
85100
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+61 2 4921 6770
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Fax
85100
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Email
85100
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
No additional documents have been identified.
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