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

Obesity Clinical Trial

Official title:

Weight Loss Effects of Mobile Health Application in Obesity Multidisciplinary Outpatient

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05168072
• Other study ID #: obesity2021
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: December 20, 2023

Study information

• Verified date: December 2021
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: December 20, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• m-Health
• NAFLD
• Obesity
• Weight Loss

Intervention

Device:
• m-Health app
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

Other:
• conventional outpatient obesity management
Diet and exercise guidance

Locations

Country	Name	City	State
China	Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in weight loss	changes in body weight from baseline were observed after 12 weeks of treatment intervention	12 weeks
Primary	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	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
Secondary	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
Secondary	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