Obesity and Type 2 DiabetesOneSTOPNCT06890169
OneSTOP (One-Stop Telehealth Obesity Program) for Multidisciplinary Weight Management and Related Comorbidities
A study testing OneSTOP program in people with Obesity and Type 2 Diabetes and NAFLD - Non-Alcoholic Fatty Liver Disease, run by Changi General Hospital at 1 site in Singapore.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Obesity and Type 2 Diabetes, NAFLD - Non-Alcoholic Fatty Liver Disease, Hypertension
- What is being tested?
- OneSTOP program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSingapore
- Study dates
- 1 May 2025to 31 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
Geraldine Lim, +65 64267818, geraldine.lim.x@singhealth.com.sg
About this study
Official title: OneSTOP (One-Stop Telehealth Obesity Program): the Use of Telecare and Digital Platforms for Multidisciplinary Management of Weight Management and Related Comorbidities
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.
Read more
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.
Read the detailed description
Design This a randomized controlled study comparing a standard weight management program of face-to-face (F2F) consults with doctors (endocrinologists and sports medicine physicians) and dieticians as defined by best-practice guidelines (control), or to the OneSTOP (One-Stop Telecare Obesity Program) a novel weight management intervention incorporating telecare and the EMPOWER app jointly developed by SingHealth and the NUS School of Computing.
Standard of care (control) The standard F2F structured weight management program consists of 4 doctor and 4 dietician consults over 26 weeks, at 2-4 weekly intervals in the first 3 months, and 6-8 weeks in the next 3 months. At the baseline visit, participants are provided with an aerobic and resistance exercise prescription individualized to each subject's fitness and comorbidities to target at least 180 minutes/week of moderate-intensity physical activity (with exercise on at least 3 days/week), and dietary advice based on a calorie-deficit diet (400-600 kilocalories less than the calculated daily caloric requirement, based on the Mifflin-St Jeor equation) which emphasizes reduction in sugar-sweetened beverages, refined carbohydrates and saturated fats. Subjects will be provided with a list of fitness resources such as gyms and fitness corners with advice on use of the equipment, and specific guidance on increasing intensity and duration of exercise and monitoring for injury. Dietary advice will be based on standard guidelines to target a calorie-deficit of 400-600 kcal from baseline. All subjects will keep food diaries and records of exercise duration for review and will also be provided with links to online resources for health advice and generic apps to track their calorie intake and physical activity. At each visit, exercise and diet records and/or results of investigations will be reviewed, and lifestyle advice modified to target at least 5% weight loss.
Intervention This will incorporate at least 50% (4 out of 8 sessions) of the doctor and dietician consults over the 26-week study as teleconsults, which may be scheduled as joint or asynchronous consults. The exercise prescription will likewise be tailored to each subject's individual needs as in the F2F structured weight management program in the control group, and similar dietary advice and reviews will be provided. In addition, participants will be taught to use the EMPOWER app will be used to enable them to upload their weight, blood pressure and glucose, food and exercise duration records. The app also has the capability to co-ordinate visits and investigations, deliver intelligent health nudges and reminders on adherence to treatment which can be individualized to their progress, and provide information on their conditions with additional information curated by their doctors and dieticians. Subjects will be able to compare the photos of their food with that in a database on the app, which will make calorie counting more precise. The app will also be paired with an activity tracker for more accurate estimates of exercise duration. Similar to the standard program, doctors and dieticians will review the exercise and diet records, results of investigations, and modify treatment according to patient response, according to standard care guidelines, aiming for at least 5% weight loss.
- Conditions
- Obesity and Type 2 Diabetes, NAFLD - Non-Alcoholic Fatty Liver Disease, Hypertension, Dyslipidaemia, Telemedicine
- Being tested
- OneSTOP program, Standard of care weight management program
- Keywords
- obesity, type 2 diabetes, masld, nafld, telecare, telemedicine
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneSTOP programBehavioural
The OneSTOP program will incorporate at least 50% (4 out of 8 sessions) of the doctor and dietician consults over the 26-week study as teleconsults, which may be scheduled as joint or asynchronous consults. The exercise prescription and calorie restriction will be tailored to each subject's individual needs as in the F2F structured weight management program in the control group. In addition, participants will be taught to use the EMPOWER app will be used to enable them to upload their weight, blood pressure and glucose, food and exercise duration records. The app also has the capability to co-ordinate visits and investigations, deliver intelligent health nudges and reminders on adherence to treatment which can be individualized to their progress, and provide information on their conditions curated by their doctors and dieticians.
Standard of care weight management programBehavioural
The standard face-to-face weight management program consists of 4 doctor and 4 dietician consults over 26 weeks, at 2-4 weekly intervals in the first 3 months, and 6-8 weeks in the next 3 months. At the baseline visit, participants are provided with an aerobic and resistance exercise prescription individualized to each subject's fitness and comorbidities to target at least 180 minutes/week of moderate-intensity physical activity (with exercise on at least 3 days/week), and dietary advice based on a calorie-deficit diet (400-600 kilocalories less than the calculated daily caloric requirement, based on the Mifflin-St Jeor equation) which emphasizes reduction in sugar-sweetened beverages, refined carbohydrates and saturated fats. Subjects will be provided with a list of fitness resources such as gyms and fitness corners with advice on use of the equipment, and specific guidance on increasing intensity and duration of exercise and monitoring for injury.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | The standard F2F structured weight management program consists of 4 doctor and 4 dietician consults over 26 weeks, at 2-4 weekly intervals in the first 3 months, and 6-8 weeks in the next 3 months. At the baseline visit, participants are provided with an aerobic and resistance exercise prescription individualized to each subject's fitness and comorbidities to target at least 180 minutes/week of moderate-intensity physical activity (with exercise on at least 3 days/week), and dietary advice based on a calorie-deficit diet (400-600 kilocalories less than the calculated daily caloric requirement, based on the Mifflin-St Jeor equation) which emphasizes reduction in sugar-sweetened beverages, refined carbohydrates and saturated fats. Subjects will be provided with a list of fitness resources such as gyms and fitness corners with advice on use of the equipment, and specific guidance on increasing intensity and duration of exercise and monitoring for injury. Receives: Behavioral: Standard of care weight management program |
| OneSTOP program | Experimental | The OneSTOP program will incorporate at least 50% (4 out of 8 sessions) of the doctor and dietician consults over the 26-week study as teleconsults, which may be scheduled as joint or asynchronous consults. The exercise prescription and calorie restriction will be tailored to each subject's individual needs as in the F2F structured weight management program in the control group. In addition, participants will be taught to use the EMPOWER app will be used to enable them to upload their weight, blood pressure and glucose, food and exercise duration records. The app also has the capability to co-ordinate visits and investigations, deliver intelligent health nudges and reminders on adherence to treatment which can be individualized to their progress, and provide information on their conditions curated by their doctors and dieticians. Receives: Behavioral: OneSTOP program |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
percentage reduction in weight from baseline
Measured: 26 weeks
Secondary outcomes (3)
percentage of subjects with reduction in weight at least 5%
percentage of subjects with reduction in weight at least 5%
Measured: 26 weeks
improvement in glycaemic control
reduction in HbA1c
Measured: 26 weeks
improvement in MASLD
reduction in severity of MASLD using liver function tests and imaging to measure hepatic steatosis and fibrosis
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start1 May 2025 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Joan Khoo Joo Ching, Changi General Hospital
- Investigators
- Joan Khoo, MBBS, FRCP, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06890169
- Sponsor's protocol ID
- OneSTOP Empower
- Acronym
- OneSTOP
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data of patients is confidential.
Publications
Khoo J, Leong AT, Rahul K, Moh LN, Min LS, Sing LP, Jia LW, Leng LL, Jiuen OL, Ong A, Hai TH, Ranu T, Victor T, Andy WJ, Eugene WYJ, Han KX, Lalmalani YM. 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. Trials. 2026 Mar 24;27(1):347. doi: 10.1186/s13063-026-09655-x.
PubMed 41877269