OneSTOP (One-Stop Telehealth Obesity Program) for Multidisciplinary Weight Management and Related Comorbidities
Recruiting · NCT06890169 · Interventional (participants receive a specific treatment) · Lead sponsor: Changi General Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to learn if the use of a care model including teleconsults and the EMPOWER app can induce clinically significant weight loss and metabolic improvements in obese adults with diabetes and metabolic dysfunction-associated steatotic liver disease (MASLD). Researchers will compare this model with the conventional standard of care of physical visit-based weight management program to see if this model is non-inferior to the standard of care for inducing weight loss, and if there is greater patient convenience with telehealth and more frequent self-monitoring, compliance with diet advice and exercise participation compared to standard of care. Participants in the standard arm will attend 4 physical doctor and 4 physical dietician consultations over 26 weeks, where they will be provided with an individualized diet and exercise prescription to induce at least 5% weight loss. Participants in the intervention arm will have the same number of consults over 26 weeks, of which at least 50% will be teleconsults, and will also be provided with an individualized diet and exercise prescription to induce at least 5% weight loss. In addition, they will be taught to use the EMPOWER app to upload weight, blood pressure and glucose, food and exercise records which will be reviewed at the consults. The app also delivers nudges to improve adherence to lifestyle modification.
Who can take part
Inclusion criteria
- Adults aged 21-70
- Body mass index \> 27.5 kg/m2
- Waist circumference \> 90 cm in men or 80 cm in women
- Suboptimal control of type 2 diabetes (HbA1c \> 6.5%) AND/OR MASLD (as defined on radiological or histological evidence of hepatic steatosis in the absence of other chronic liver disease)
Exclusion criteria
- Men who drink \> 21 units/week and women who drink \> 14 units/week of alcohol
- Participants previously on weight-lowering medications (however if they are keen to participate, there will be a minimum wash-out period of 3 months before participation)
- Illness with life expectancy of less than 6 months
- Inability to comply with written instructions in English
Where it is running
2 locations listed.
- Changi General Hospital - Singapore, Singapore
- Changi General Hospital - Singapore, Singapore