ANZCTR - Registration

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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

Secondary ID [1]

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

Condition category

Condition code

Diet and Nutrition

Obesity

Oral and Gastrointestinal

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]

Treatment: Devices

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Change in weight, measured in kilograms using digital weighing scale.

Timepoint [1]

Measured at baseline, 3-month, 6-month of intervention.

Secondary outcome [1]

Body mass index using body weight in kilograms and height in metres

Timepoint [1]

At baseline, 3-month and 6-month of intervention

Secondary outcome [2]

Change in waist-hip ratio. Waist and hip circumference are measured in centimeters using a measuring tape

Timepoint [2]

At baseline, 3-month, 6-month of intervention

Secondary outcome [3]

Change in liver enzymes - alanine transferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), measured by using whole blood sample

Timepoint [3]

At baseline (no more than 1 month of recruitment), 3-month and 6-month, if available.

Secondary outcome [4]

Change in lipid panel (total cholesterol, triglycerides, LDL, HDL), measured by using whole blood sample collected in plain tube

Timepoint [4]

At baseline, 3-month, 6-month of intervention

Secondary outcome [5]

change in HbA1c %, measured by using whole blood sample collected in EDTA tube

Timepoint [5]

At baseline, 3-month, 6-month of intervention

Secondary outcome [6]

Fasting blood glucose, measured by using whole blood sample collected in plain/fluoride tube

Timepoint [6]

At baseline, 3-month, 6-month of intervention

Secondary outcome [7]

Blood pressure

Timepoint [7]

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?

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]

Singapore

State/province [1]

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

National University Hospital System ALLIED HEALTH AND NURSING GRANT

Address [1]

National University Hospital
1E Kent Ridge Rd, Singapore 119228

Country [1]

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]

Individual

Name [1]

Lee Yin Mei

Address [1]

National University Hospital
1E Kent Ridge Rd, Singapore 119228

Country [1]

Singapore

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

National Healthcare Group Domain Specific Review Board Domain D

Ethics committee address [1]

Domain Specific Review Board (DSRB)
c/o National Healthcare Group, Research & Development Office (RDO)
Nexus @One-North (South Tower), No. 3 Fusionopolis Link, #03-08
Singapore 138543

Ethics committee country [1]

Date submitted for ethics approval [1]

10/03/2017

Approval date [1]

11/05/2017

Ethics approval number [1]

2017/00233

Summary

Brief summary

Non-Alcoholic Fatty Liver Disease (NAFLD) is the build-up of extra fat in the liver which is not caused by alcohol. It is one of the most prevalent liver diseases worldwide. In Asia, an estimated 20% to 30% of the adult population has NAFLD, with a higher prevalence in obese patients. Fatty liver can progress to Nonalcoholic Steatohepatitis (NASH), with varying degrees of inflammation and scarring (fibrosis). It can further progress to cirrhosis (permanent scarring and hardening of the liver), which can then lead to liver failure. Fatty liver and NASH are reversible but cirrhosis is irreversible.

Lifestyle interventions have been considered fundamental for the therapeutic management of NAFLD, and it has been shown that the success of the treatment is associated with the intensity of nutrition counselling and visits to the dietitians and exercise therapists. However, this modality of treatment is resource-intensive, costly, has high default rate and limited reach. An alternative way to overcome these challenges is to explore the use of mobile technologies in facilitating weight loss in patients with NAFLD.

Mobile technology as a mode to facilitate lifestyle intervention is attractive to patient as it is convenient, saves time, provides real-time information at the finger-tips and saves cost. It is also potentially attractive to the tech-savvy and busy working age-group of NAFLD patients who mostly range between 30-50 years old. Of late, mobile technologies have been increasingly more popular in facilitating weight loss. However, this mobile technology-enabled modality of treatment has not been tested in patients with NALFD in a clinical setting.

The objective of the present study is to evaluate the effectiveness of lifestyle intervention enabled by locally developed and targeted mobile technologies to facilitate behavioural change which leads to weight loss in patients with NAFLD. Outcome measures will be tracked at 3-month and 6-month post intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Lim Su Lin

Address

National University Hospital, Dietetics Department
5 Lower Kent Ridge Road, Main Building, Level 1,
Singapore 119074

Country

Singapore

Phone

+65 6772 4580

Fax

+65 6779 1938

su_lin_lim@nuhs.edu.sg

Contact person for public queries

Name

Ong Kai Wen

Address

National University Hospital, Dietetics Department
5 Lower Kent Ridge Road, Main Building, Level 1,
Singapore 119074

Country

Singapore

Phone

+65 6772 5166

Fax

+65 6779 1938

kai_wen_ong@nuhs.edu.sg

Contact person for scientific queries

Name

Lim Su Lin

Address

National University Hospital, Dietetics Department
5 Lower Kent Ridge Road, Main Building, Level 1,
Singapore 119074

Country

Singapore

Phone

+65 6772 4580

Fax

+65 6779 1938

su_lin_lim@nuhs.edu.sg

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Source	Title	Year of Publication	DOI
Embase	Lifestyle Intervention Enabled by Mobile Technology on Weight Loss in Patients With Nonalcoholic Fatty Liver Disease: Randomized Controlled Trial.	2020	https://dx.doi.org/10.2196/14802

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically