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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
Scientific title
Evaluating the Efficacy of a Body Weight Management Smartphone App for People Living with Chronic Illness: a Randomised Controlled Trial
Secondary ID [1] 295430 0
Not Applicable
Universal Trial Number (UTN)
Not Applicable
Trial acronym
Not Applicable
Linked study record
Not Applicable

Health condition
Health condition(s) or problem(s) studied:
Overweight 308687 0
Chronic illness 308688 0
Obese 308810 0
Condition category
Condition code
Cardiovascular 307614 307614 0 0
Other cardiovascular diseases
Diet and Nutrition 307615 307615 0 0
Obesity

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 301741 0
Behaviour
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.
Control group
Active

Outcomes
Primary outcome [1] 306597 0
Body weight
The body weight will be self-reported weekly by the participants in "Weight Tracker" component in the app
Timepoint [1] 306597 0
Baseline, 6-weeks, 3-month (primary endpoint) and 6-months post-recruitment
Secondary outcome [1] 348965 0
BMI calculated by research team based on self-reported weight and height by particpants
Timepoint [1] 348965 0
Baseline, 6-weeks, 3-month and 6-months post-recruitment
Secondary outcome [2] 349397 0
Mood measured by Patient Health Questionnaire
Timepoint [2] 349397 0
Baseline, 6-weeks, 3-month and 6-months post-recruitment
Secondary outcome [3] 349398 0
Activities measured by Daily activity diary
Timepoint [3] 349398 0
Baseline, 6-weeks, 3-month and 6-months post-recruitment
Secondary outcome [4] 349399 0
Quality of life measured by SF-12 questionnaire
Timepoint [4] 349399 0
Baseline, 6-weeks, 3-month and 6-months post-recruitment

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Self-report a diagnosis of severe mental illness
2) Currently pregnant or planning on becoming pregnant during the intervention.

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)
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.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
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.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
15/08/2018
Actual
Date of last participant enrolment
Anticipated
20/08/2019
Actual
Date of last data collection
Anticipated
28/02/2020
Actual
Sample size
Target
76
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11316 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment postcode(s) [1] 23214 0
2444 - Port Macquarie

Funding & Sponsors
Funding source category [1] 300016 0
Government body
Name [1] 300016 0
Mid North Coast Local Health District Research Support Grant
Country [1] 300016 0
Australia
Primary sponsor type
Government body
Name
Mid North Coast Local Health District
Address
Morton Street
Port Macquarie NSW
2444
Country
Australia
Secondary sponsor category [1] 299409 0
None
Name [1] 299409 0
Address [1] 299409 0
Country [1] 299409 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300869 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 300869 0
Ethics committee country [1] 300869 0
Australia
Date submitted for ethics approval [1] 300869 0
05/12/2017
Approval date [1] 300869 0
07/02/2018
Ethics approval number [1] 300869 0
17/12/13/4.08

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

Contacts
Principal investigator
Name 85098 0
Prof Sally Chan
Address 85098 0
School of Nursing and Midwifery
The University of Newcastle
University Drive
Callaghan NSW
2308
Country 85098 0
Australia
Phone 85098 0
+61 2 4921 6770
Fax 85098 0
Email 85098 0
[email protected]
Contact person for public queries
Name 85099 0
Sally Chan
Address 85099 0
School of Nursing and Midwifery
The University of Newcastle
University Drive
Callaghan NSW
2308
Country 85099 0
Australia
Phone 85099 0
+61 2 4921 6770
Fax 85099 0
Email 85099 0
[email protected]
Contact person for scientific queries
Name 85100 0
Sally Chan
Address 85100 0
School of Nursing and Midwifery
The University of Newcastle
University Drive
Callaghan NSW
2308
Country 85100 0
Australia
Phone 85100 0
+61 2 4921 6770
Fax 85100 0
Email 85100 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
No additional documents have been identified.