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

NCT ID: NCT05168072

Last Updated: 2021-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2023-12-20

Brief Summary

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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

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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.

Conditions

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Obesity m-Health NAFLD

Keywords

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obesity NAFLD m-Health

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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m-Health

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

Group Type EXPERIMENTAL

m-Health app

Intervention Type DEVICE

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

conventional outpatient obesity management

Intervention Type OTHER

Diet and exercise guidance

conventional

participants receive conventional outpatient obesity management

Group Type ACTIVE_COMPARATOR

conventional outpatient obesity management

Intervention Type OTHER

Diet and exercise guidance

Interventions

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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

Intervention Type DEVICE

conventional outpatient obesity management

Diet and exercise guidance

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role lead

Responsible Party

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Dalong Zhu

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dalong Zhu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

the Affiliated Drum Tower Hospital of Nanjing University

Locations

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

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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obesity2021

Identifier Type: -

Identifier Source: org_study_id