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

Not Applicable

• Conditions: Obesity; NAFLD; m-Health
• Interventions: Other: conventional outpatient obesity management; Device: m-Health app

• Registration Number: NCT05168072
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-01
• Study Start: 2021-12-10
• Study First Submitted QC: 2021-12-22
• Last Update Submitted: 2021-12-22
• Study First Posted: 2021-12-23
• Last Update Posted: 2021-12-23
• Primary Completion: 2022-12-20
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional	conventional outpatient obesity management	participants receive conventional outpatient obesity management
m-Health	conventional outpatient obesity management	participants receive conventional outpatient obesity management assisted with m-Health APP
m-Health	m-Health app	participants receive conventional outpatient obesity management assisted with m-Health APP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase	12 weeks	The changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase would be measured at the beginning and the end.
Changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol	12 weeks	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.
Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects	12 weeks	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

Trial Locations

Locations (1)

Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China