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

• Register: ANZCTR
• Last refreshed on: 27 April 2020
• Main ID: ACTRN12617001001381
• Date of registration: 11/07/2017
• Prospective Registration: Yes
• Primary sponsor: Lim Su Lin
• 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
• Date of first enrolment: 14/07/2017
• Target sample size: 110
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12617001001381.aspx
• Study type: Interventional
• Study design: Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Singapore

Contacts

• Name: Ms Ong Kai Wen

• Name: Dr Lim Su Lin

Key inclusion & exclusion criteria

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
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


Age minimum: 21 Years
Age maximum: 70 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Non-Alcoholic Fatty Liver Disease;
Non-Alcoholic Fatty Liver Disease

Diet and Nutrition - Obesity

Intervention(s)

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

Primary Outcome(s)

Change in weight, measured in kilograms using digital weighing scale.[Measured at baseline, 3-month, 6-month of intervention.]

Secondary Outcome(s)

Fasting blood glucose, measured by using whole blood sample collected in plain/fluoride tube[At baseline, 3-month, 6-month of intervention]

Change in liver enzymes - alanine transferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), measured by using whole blood sample[At baseline (no more than 1 month of recruitment), 3-month and 6-month, if available. ]

Body mass index using body weight in kilograms and height in metres[At baseline, 3-month and 6-month of intervention]

Change in lipid panel (total cholesterol, triglycerides, LDL, HDL), measured by using whole blood sample collected in plain tube[At baseline, 3-month, 6-month of intervention]

change in HbA1c %, measured by using whole blood sample collected in EDTA tube[At baseline, 3-month, 6-month of intervention]

Change in waist-hip ratio. Waist and hip circumference are measured in centimeters using a measuring tape[At baseline, 3-month, 6-month of intervention]

Blood pressure[At baseline, 3-month, 6-month of intervention]

Secondary ID(s)

Nil known

Source(s) of Monetary Support

National University Hospital System ALLIED HEALTH AND NURSING GRANT

Secondary Sponsor(s)

Lee Yin Mei

Ethics review

Status: Approved
Approval date: 11/05/2017
Contact:

National Healthcare Group Domain Specific Review Board Domain D

Results

• Results available: Yes
• Date Posted: 22/04/2020
• Date Completed: 30/11/2018