Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001001381
Ethics application status
Approved
Date submitted
17/05/2017
Date registered
11/07/2017
Date last updated
22/04/2020
Date data sharing statement initially provided
22/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Randomised Controlled Trial on the effect of lifestyle intervention enabled by mobile technologies versus standard treatment to facilitate weight loss in patients with Non-alcoholic Fatty Liver Disease
Scientific title
Randomised Controlled Trial on the effect of lifestyle intervention enabled by mobile technologies versus standard treatment to facilitate weight loss in patients with Non-alcoholic Fatty Liver Disease
Secondary ID [1] 291945 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-Alcoholic Fatty Liver Disease 303287 0
Condition category
Condition code
Diet and Nutrition 302718 302718 0 0
Obesity
Oral and Gastrointestinal 302996 302996 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention is the use of a locally designed mobile application called Nutritionist Buddy (nBuddy) facilitating behavioural change for weight loss in participants with Non-Alcoholic Fatty Liver Disease. The intervention is over a period of 6 months. This group will be guided through the use of the application through a 1 hour individual face-to-face session with the research dietitian at their first study visit. The application is provided free for these patients and they will be required to log their food intake and exercise daily. The nBuddy app will provide the participants with real-time decision-support response if the food selected is the not the best choice for him or her. They will be required to input their weekly weight using the digital weighing machine issued to them. Participants will be guided to achieve their targeted goals using in-built evidenced based behaviour modification tool. With the remote coaching through the dashboard, dietitian can view participants' diet and activities history. The chat function allows dietitian to communicate with participants daily for the first month and weekly for the subsequent months, or as and when required. Within the programme, participants will be provided with educational videos on strategies for weight loss and behavioural modifications.
A buddy support system can also be set up by participant's invitation to the application. Loved ones or friends whom the participant wishes to be accountable to, can access his or her diet and exercise history to help monitor and encourage him or her to stay on track.

Two optional workshops will be lined up for participants to join. One will be conducted on behavioural strategies for weight loss or a supermarket tour, and the other will be on the topic of sustaining weight loss.

The automation engine of the application will be able to:
- evaluate suitability of foods or meal plans in real-time and generate healthier alternatives automatically and immediately via an algorithm
- provide reports on calorie intake, calories burnt and weight in graphical formats to participants on a regular basis
- provide evidenced-based daily tips to users
- Send scripted reminders or prompts at certain time of the day, based on user's level of preference
- Implement behavioural modification strategies automatically in order to achieve and sustain good outcomes.

Dietitian dashboard will complement the application with:
- Timely escalation of question and answer
- Tracking and monitoring of results and outcomes of participants
- View participants' information such as their food choices, diet plan, exercise level
- Support and individualised feedback to users via the application
- Weekly educational videos to participants via the application
Intervention code [1] 298076 0
Treatment: Devices
Intervention code [2] 298077 0
Lifestyle
Intervention code [3] 298078 0
Behaviour
Comparator / control treatment
As per our current standard care, participants in control arm will be counselled individually on diet and exercise advice by a nurse practitioner during their clinic visit. The session takes approximately 30 to 40 minutes and is once off. Healthy food plate , physical activity and the importance of weight loss are key areas of focus during the counselling. They will be provided with a weighing machine for the purpose of this study.
Control group
Active

Outcomes
Primary outcome [1] 302125 0
Change in weight, measured in kilograms using digital weighing scale.
Timepoint [1] 302125 0
Measured at baseline, 3-month, 6-month of intervention.
Secondary outcome [1] 334890 0
Body mass index using body weight in kilograms and height in metres
Timepoint [1] 334890 0
At baseline, 3-month and 6-month of intervention
Secondary outcome [2] 334891 0
Change in waist-hip ratio. Waist and hip circumference are measured in centimeters using a measuring tape
Timepoint [2] 334891 0
At baseline, 3-month, 6-month of intervention
Secondary outcome [3] 334892 0
Change in liver enzymes - alanine transferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), measured by using whole blood sample
Timepoint [3] 334892 0
At baseline (no more than 1 month of recruitment), 3-month and 6-month, if available.
Secondary outcome [4] 334893 0
Change in lipid panel (total cholesterol, triglycerides, LDL, HDL), measured by using whole blood sample collected in plain tube
Timepoint [4] 334893 0
At baseline, 3-month, 6-month of intervention
Secondary outcome [5] 334895 0
change in HbA1c %, measured by using whole blood sample collected in EDTA tube
Timepoint [5] 334895 0
At baseline, 3-month, 6-month of intervention
Secondary outcome [6] 334896 0
Fasting blood glucose, measured by using whole blood sample collected in plain/fluoride tube
Timepoint [6] 334896 0
At baseline, 3-month, 6-month of intervention
Secondary outcome [7] 334971 0
Blood pressure
Timepoint [7] 334971 0
At baseline, 3-month, 6-month of intervention

Eligibility
Key inclusion criteria
The study is conducted in Singapore, at National University Hospital.

The inclusion criteria includes:
- Adult patients adults above 21-70 years old who have been diagnosed with NAFLD, confirmed by the presence of steatosis in the liver on ultrasound.
- Have BMI greater and equal to 23 kg/m2
- Own a smart-phone with data plan
- English-speaking
- Willing to consent to the study
Minimum age
21 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they meet the following criteria:
- Consumption of more than 1.5 times the limit of alcohol recommended for the population (alcohol dose 15 g/week for women and 30 g/week for men)
- no serologic evidence of previous hepatitis B or C infection, chronic liver disease or cirrhosis or concomitant liver diseases
- pregnant
- on hepatotoxic medication
- poorly controlled diabetes mellitus (HbA1c > 10%), diabetes needing insulin,
- recent cardiovascular event in the past 6 months, known heart failure
- stage 4 and above kidney disease
- untreated hypothyroidism, depression
- mentally challenged
- biochemically recognized systemic diseases
- unwilling to provide informed consent

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation of screened participants to control or experimental group will be done via sealed opaque envelopes, which will be prepared by a third party not involved in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation will be performed according to gender, BMI (< 27.5 kg/m2) or >/= 27.5 kg/m2), and age (< 40 year old or >/= 40 year old), effected by sealed envelopes, which has equal number of "intervention" and "control".
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
Postulating that there will be a mean difference in weight loss of 2.1 kg between control and intervention groups at 6-month follow-up, with 90% power at 5% significance level, and allowing for a 10% dropout rate, it is estimated that a sample size of 100 (50 per group) would be needed.
All analyses will be performed using SPSS for Windows version 21.0 (SPSS Inc, Chicago, IL, USA). Results will be expressed as mean and standard deviation for normally distributed variables and median and interquartile range for variables that did not satisfy normality criteria. Categorical data will be expressed as frequencies and percentages. To compare baseline characteristics between the control and intervention groups, for continuous variables, the appropriate parametric (independent samples t-test) and nonparametric tests (Mann-Whitney U test) will be utilized. For categorical variables, the chi-square test will be used. Between-group differences in the outcomes (weight change at 3 and 6 months) will be investigated using the analysis of covariance (ANCOVA) adjusted for baseline measurements.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/07/2017
Actual
14/07/2017
Date of last participant enrolment
Anticipated
30/06/2018
Actual
31/05/2018
Date of last data collection
Anticipated
31/12/2018
Actual
30/11/2018
Sample size
Target
110
Accrual to date
Final
108
Recruitment outside Australia
Country [1] 8905 0
Singapore
State/province [1] 8905 0

Funding & Sponsors
Funding source category [1] 296457 0
Hospital
Name [1] 296457 0
National University Hospital System ALLIED HEALTH AND NURSING GRANT
Country [1] 296457 0
Singapore
Primary sponsor type
Individual
Name
Lim Su Lin
Address
National University Hospital, Dietetics Department,
5 Lower Kent Ridge Road, Main Building, Level 1
Singapore 119074
Country
Singapore
Secondary sponsor category [1] 295413 0
Individual
Name [1] 295413 0
Lee Yin Mei
Address [1] 295413 0
National University Hospital
1E Kent Ridge Rd, Singapore 119228
Country [1] 295413 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297682 0
National Healthcare Group Domain Specific Review Board Domain D
Ethics committee address [1] 297682 0
Ethics committee country [1] 297682 0
Date submitted for ethics approval [1] 297682 0
10/03/2017
Approval date [1] 297682 0
11/05/2017
Ethics approval number [1] 297682 0
2017/00233

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

Contacts
Principal investigator
Name 74806 0
Dr Lim Su Lin
Address 74806 0
National University Hospital, Dietetics Department
5 Lower Kent Ridge Road, Main Building, Level 1,
Singapore 119074
Country 74806 0
Singapore
Phone 74806 0
+65 6772 4580
Fax 74806 0
+65 6779 1938
Email 74806 0
[email protected]
Contact person for public queries
Name 74807 0
Ong Kai Wen
Address 74807 0
National University Hospital, Dietetics Department
5 Lower Kent Ridge Road, Main Building, Level 1,
Singapore 119074
Country 74807 0
Singapore
Phone 74807 0
+65 6772 5166
Fax 74807 0
+65 6779 1938
Email 74807 0
[email protected]
Contact person for scientific queries
Name 74808 0
Lim Su Lin
Address 74808 0
National University Hospital, Dietetics Department
5 Lower Kent Ridge Road, Main Building, Level 1,
Singapore 119074
Country 74808 0
Singapore
Phone 74808 0
+65 6772 4580
Fax 74808 0
+65 6779 1938
Email 74808 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
No


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
EmbaseLifestyle Intervention Enabled by Mobile Technology on Weight Loss in Patients With Nonalcoholic Fatty Liver Disease: Randomized Controlled Trial.2020https://dx.doi.org/10.2196/14802
N.B. These documents automatically identified may not have been verified by the study sponsor.