OneSTOP (One-Stop Telehealth Obesity Program) for Multidisciplinary Weight Management and Related Comorbidities

NCT06890169 | Recruiting

• 1 other identifier: OneSTOP Empower
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Obesity and Type 2 Diabetes; NAFLD - Non-Alcoholic Fatty Liver Disease; Hypertension; Dyslipidaemia; Telemedicine

Keywords

obesity; type 2 diabetes; masld; nafld; telecare; telemedicine

Outcome Measures

Primary Outcomes (1)

• weight loss

  percentage reduction in weight from baseline

  26 weeks

Secondary Outcomes (3)

• percentage of subjects with reduction in weight at least 5%

  26 weeks

• improvement in glycaemic control

  26 weeks

• improvement in MASLD

  26 weeks

Study Arms (2)

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.

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.

Behavioral: OneSTOP program

Interventions

OneSTOP program BEHAVIORAL

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.

OneSTOP program

Standard of care weight management program BEHAVIORAL

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.

Control

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead
• National University of Singapore: collaborator

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

RECRUITING

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Hypertension; Dyslipidemias; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Joan Khoo, MBBS, FRCP

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan Khoo, MBBS, FRCP

CONTACT

+65 69365641; joan.khoo.j.c@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)