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Clinical Trials/NCT05168072
NCT05168072
Unknown
Not Applicable

Weight Loss Effects of Mobile Health Application in Obesity Multidisciplinary Outpatient

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 site in 1 country80 target enrollmentDecember 10, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obesity
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Enrollment
80
Locations
1
Primary Endpoint
Changes in weight loss
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 10, 2021
End Date
December 20, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Responsible Party
Principal Investigator
Principal Investigator

Dalong Zhu

Chief Physician

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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)

Outcomes

Primary Outcomes

Changes in weight loss

Time Frame: 12 weeks

changes in body weight from baseline were observed after 12 weeks of treatment intervention

Changes in Nonalcoholic fatty liver disease

Time Frame: 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 Outcomes

  • Changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase(12 weeks)
  • Changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol(12 weeks)
  • Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects(12 weeks)

Study Sites (1)

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