None listed
Conditions
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.
Interventions
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 requ
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
Sponsors
Lim Su Lin
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 70 Years
Healthy volunteers
No
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
Outcome results
None listed