OneSTOP (One-Stop Telehealth Obesity Program): study protocol for an open-label randomized controlled trial on the use of telecare and digital platforms for multidisciplinary management of weight management and related comorbidities.

backgroundObesity is prevalent in Singapore and is a driver of multiple co-morbidities including type 2 diabetes, metabolic dysfunction associated steatotic liver disease (MASLD), and cardiovascular disease. Traditional weight management programs have drawbacks of minimal contact with patients in between appointments leading to loss of motivation, patients defaulting appointments, and non-compliance to treatment regimes. While there is a plethora of apps for lifestyle modification and health messaging, there is an unmet need for a one-stop weight management program for patients with significant obesity-related complications, particularly MASLD, where there have been relatively few studies to date on the use of telemedicine and digital therapies for lifestyle intervention.

methodsThis is a single-center open-label randomized controlled trial with two study arms-Telehealth + EMPOWER app care model vs control arm which comprises of a standard weight management program of face-to-face (F2F) consults with doctors and dieticians as defined by best-practice guidelines for inducing clinically significant metabolic improvements in obese adults with diabetes mellitus and MASLD. Patients in the telehealth arm will receive a combination of face-to-face consultations and tele-consults in addition to access to the EMPOWER app, which can be used for food and exercise diary and can provide users reminders and nudges on behavioral changes. The primary outcome in our study is percentage change in weight at 26 weeks. Secondary outcomes are percentage of subjects with reduction in weight of at least 5% at 26 weeks, improvement in glycemic control (as measured by HbA1c) at 12 and 26 weeks, and severity of MASLD using liver function tests and imaging to measure hepatic steatosis and fibrosis non-invasively at 26 weeks. DISCUSSION: Obesity, DM, and MASLD carry significant healthcare costs and weight loss of 5-10% improves glycemic control and thus decreases macro- and microvascular complications of diabetes and can significantly decrease the severity of liver disease in as little as 6 months to a year.

trial registrationClinicalTrials.gov NCT06890169. Registered on March 17, 2025. https://clinicaltrials.gov/study/NCT06890169?term=NCT06890169&rank=1.