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

Primary Purpose

Obesity, m-Health, NAFLD

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
m-Health app
conventional outpatient obesity management
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, NAFLD, m-Health

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

m-Health

conventional

Arm Description

participants receive conventional outpatient obesity management assisted with m-Health APP

participants receive conventional outpatient obesity management

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
December 1, 2021
Last Updated
December 22, 2021
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05168072
Brief Title
Weight Loss Effects of M-health App in Obesity Multidisciplinary Outpatient Clinic
Official Title
Weight Loss Effects of Mobile Health Application in Obesity Multidisciplinary Outpatient
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, m-Health, NAFLD
Keywords
obesity, NAFLD, m-Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
m-Health
Arm Type
Experimental
Arm Description
participants receive conventional outpatient obesity management assisted with m-Health APP
Arm Title
conventional
Arm Type
Active Comparator
Arm Description
participants receive conventional outpatient obesity management
Intervention Type
Device
Intervention Name(s)
m-Health app
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
conventional outpatient obesity management
Intervention Description
Diet and exercise guidance
Primary Outcome Measure Information:
Title
Changes in weight loss
Description
changes in body weight from baseline were observed after 12 weeks of treatment intervention
Time Frame
12 weeks
Title
Changes in Nonalcoholic fatty liver disease
Description
Changes in Nonalcoholic fatty liver disease (hepatic fibrosis index and liver fat attenuation parameters measured by Fibro touch) after 12 weeks of treatment
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects
Description
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
Time Frame
12 weeks
Title
Changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol
Description
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.
Time Frame
12 weeks
Title
Changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase
Description
The changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase would be measured at the beginning and the end.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalong Zhu, MD,PhD
Organizational Affiliation
the Affiliated Drum Tower Hospital of Nanjing University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China

12. IPD Sharing Statement

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

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