Weight Loss Effects of M-health App in Obesity Multidisciplinary Outpatient Clinic

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open, controlled, single-center trial to identify the weight loss effects of adding mobile health application in obesity multidisciplinary outpatient clinic.

Detailed Description
-----------------
This is a randomized, open, controlled, single-center trial to identify the weight loss effects of adding mobile health application in obesity multidisciplinary outpatient clinic. The team of obesity multidisciplinary outpatient clinic includes endocrinologists, dietitians, and exercisers. The endocrinologist assesses the patients' conditions, manages the patients, and decides on appropriate medications. Dietitians participate in dietary propaganda and education, and develop personalized diet prescriptions. Exercisers conduct behavior and exercise propaganda, and issue personalized exercise prescriptions. Patients in the experimental group combine m-Health APP with routine obesity clinic management. The m-Health APP could help patients set weight loss targets, record body weights online, learn the calories they consumed in real time, and exercise based on the prescriptions suggested by the exercisers.

Official Title
-----------------
Weight Loss Effects of Mobile Health Application in Obesity Multidisciplinary Outpatient

Conditions
-----------------
Obesity, m-Health, NAFLD

Intervention / Treatment
-----------------
* Device: m-Health app
* Other: conventional outpatient obesity management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between 18 and 65 years old; 24kg/m^2 ≤ BMI < 37.5kg/m^2; Proficient in using mobile applications; Agree to sign the informed consent Exclusion Criteria: secondary obesity (such as hypothyroidism, Cushing's syndrome, hypothalamic obesity or long-term use of obesity-causing drugs, etc.); Patients with chronic diseases that require special diet and affect exercise; Patients suffering from severe liver, kidney or heart dysfunction; Patients with a history of malignant tumor; Pregnant or lactating women; Low level of education or illiteracy; Inability, unwillingness, or refusal to comply with study requirements (including lifestyle adjustments, follow-up, and subject duties)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: m-Health<br>participants receive conventional outpatient obesity management assisted with m-Health APP | Device: m-Health app<br>* M-Health app is used to set weight loss targets and record body weights online. Participants learn the calories they consumed by using the m-Health APP and follow the APP for physical exercise<br>Other: conventional outpatient obesity management<br>* Diet and exercise guidance<br>|
| Active Comparator: conventional<br>participants receive conventional outpatient obesity management | Other: conventional outpatient obesity management<br>* Diet and exercise guidance<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weight loss | changes in body weight from baseline were observed after 12 weeks of treatment intervention | 12 weeks | 
| Changes in Nonalcoholic fatty liver disease | Changes in Nonalcoholic fatty liver disease (hepatic fibrosis index and liver fat attenuation parameters measured by Fibro touch) after 12 weeks of treatment | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects | All 40 subjects of each group would be evaluated by changes in body mass index ( BMI(kg/m^2)=body weight(kg)/height(m^2)) after 12 weeks treatment | 12 weeks | 
| Changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol | The changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol would be measured at the beginning and the end. | 12 weeks | 
| Changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase | The changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase would be measured at the beginning and the end. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
m-Health, obesity, NAFLD