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临床试验/NCT05168072
NCT05168072Unknown不适用

Weight Loss Effects of Mobile Health Application in Obesity Multidisciplinary Outpatient

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年12月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Changes in weight loss

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

Changes in weight loss

时间窗: 12 weeks

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

Changes in Nonalcoholic fatty liver disease

时间窗: 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

次要结局

  • 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)

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dalong Zhu

Chief Physician

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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