App and Body Fat Scale in the Management of Overweight Patients

Schizophrenia Clinical Trial

Official title: The Effectiveness and Feasibility of Health App and Smart Body Fat Scale in the Management of Health Outcomes in the Overweight Patients Treated With Antipsychotics: a Stepped-wedge Cluster Randomized Study

Status Not yet recruiting

Clinical Trial Summary

Primary objective:

To examine the impact of the sustained use of the health app and smart body fat scale on weight management and patient engagement

Secondary objectives:

1. To compare the difference in weight loss between the participants who have good compliance to app + scale protocol and the participants who have bad compliance

2. To evaluate the longitudinal association between self-monitoring adherence and percent weight loss.

3. To evaluate the prospective association between monthly % weight loss and the subsequent month of self-monitoring adherence

List the clinical hypotheses:

1. At least 50% of participants will achieve 7% weight reduction compared with baseline by self-weight monitoring using smart body fat scale and health app.

2. The self-monitoring adherence is associated with greater weight loss.

3. The monthly weight loss is associated with the subsequent month of self-monitoring adherence.

4. The self-weight monitoring using smart body fat scale and health app are feasible by evaluating the compliance and completeness of the data.

Clinical Trial Description

The investigators will recruit the patients diagnosed with schizophrenia or bipolar disorder from Beijing Anding Hospital. Participants will use a mobile phone app (Huawei Health) to collect data on sleep log, daily activities and calorie consumption. The smart body fat scale with high-precision weighing chip (Huawei Scale 2pro) will be used to collect heart rate, weight, BMI, body type, basal metabolic rate, fat rate, fat free body weight, skeletal muscle mass, bone salt content, visceral fat grade, body water (%), body protein rate and body composition, and all data will be uploaded to the app. Participants could also record their daily dietary intake (for calculation of calorie intake) in the health app.

This is a 6-month, single-center, stepped wedge-shaped cluster randomized study. It is planned to recruit 200 overweight subjects, including 100 patients with schizophrenia and 100 patients with bipolar disorder, who are receiving antipsychotics,. Interventions included self-monitoring of weight using smart body fat scale, dietary management, and exercise management. The follow-up team consists of a psychiatrist, nutrition instructor, and exercise instructor who set weight loss goals and implemented a plan. The patients themselves use the health APP and smart body fat scale to record health data such as body weight; psychiatrists evaluate the patient's condition and conduct laboratory tests; nutrition instructors conduct dietary education and formulate individualized energy-limited balanced diet prescriptions; exercise instructors conduct behavioral ways and sports education, and individualized exercise prescriptions. ;

Related Conditions & MeSH terms

• Bipolar Disorder
• Metabolic Syndrome
• Overweight
• Schizophrenia

• NCT number: NCT05866107
• Study type: Interventional
• Source: Capital Medical University
• Contact: Xiao Le
• Phone: +8613466604224
• Email: xiaole373@163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 15, 2023
• Completion date: December 31, 2024