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

NCT05168072 | Unknown

• 1 other identifier: obesity2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; m-Health; NAFLD

Keywords

obesity; NAFLD; m-Health

Outcome Measures

Primary Outcomes (2)

• Changes in weight loss

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

  12 weeks

• 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

  12 weeks

Secondary Outcomes (3)

• Changes in body mass index (BMI(kg/m^2)=body weight(kg)/height(m^2)) of subjects

  12 weeks

• Changes in serum triglycerides, total cholesterol, high-density lipoprotein cholesterol and low-density lipoprotein cholesterol

  12 weeks

• Changes in serum alanine aminotransferase, aspartate aminotransferase and glutyltranspeptidase

  12 weeks

Study Arms (2)

m-Health

EXPERIMENTAL

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

Device: m-Health app; Other: conventional outpatient obesity management

conventional

ACTIVE COMPARATOR

participants receive conventional outpatient obesity management

Other: conventional outpatient obesity management

Interventions

m-Health app 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

m-Health

conventional outpatient obesity management OTHER

Diet and exercise guidance

conventional; m-Health

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between 18 and 65 years old;
• kg/m\^2 ≤ BMI \< 37.5kg/m\^2;
• Proficient in using mobile applications;
• Agree to sign the informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Obesity; Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Dalong Zhu, MD,PhD

  the Affiliated Drum Tower Hospital of Nanjing University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: December 1, 2021
• First Posted: December 23, 2021
• Study Start: December 10, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2023
• Last Updated: December 23, 2021

Record last verified: 2021-12

Locations

CN (1)