Clinical trial NCT05168072: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
m-Health
NAFLD
Keywords: obesity
NAFLD
m-Health
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2021-12-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Changes in weight loss
timeFrame: 12 weeks
measure: Changes in Nonalcoholic fatty liver disease
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects
timeFrame: 12 weeks
measure: Changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol
timeFrame: 12 weeks
measure: Changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
state: Jiangsu
Study officials:
affiliation: the Affiliated Drum Tower Hospital of Nanjing University
name: Dalong Zhu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: