NCT06455878

Mobile Applet for Weight Management in Obese Heart Failure Patients

The Impact of Dietary Management Applet for Weight Reduction in Obese Heart Failure Patients: a Multicenter, Single-blind Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 830 (estimated)
• Sponsor: Heart Health Research Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical trial is to investigate the effect of weight reduction through a diet management application and an intelligent weight scale on a composite cardiovascular endpoint in obese patients with heart failure. The main questions are: Does the use of a diet management APP and intelligent weight scale reduce 1-year all-cause mortality, heart failure hospitalization, and first heart failure hospital stay? Does the use of a diet management APP and intelligent weight scale improve the outcomes of assessment of heart failure frailty and quality of life for heart failure? Researchers will compare using the fully functional diet management app and intelligent weight scale to using the limitedly functional app and intelligent weight scale to see if the app works to improve heart failure conditions. Participants will: Use the diet management app at every meal and the intelligent weight scale every day for 12 months, and visit the clinic at 12 months for checkups.

Detailed description

Obesity is one of the major risk factors for heart failure. Current guidelines for heart failure emphasize that severe obesity is associated with a poor prognosis in patients with heart failure, but there are no recommended effective interventions. Caloric restriction alone, increased exercise, the use of weight-loss drugs, and bariatric surgery are not appropriate for obese patients with heart failure. Whether obese heart failure patients with reduced ejection fraction (HFrEF) can benefit from weight loss treatment has not been evaluated in randomized controlled trials so far. This study combines caloric restriction with lifestyle management to help HFrEF patients lose weight.

Conditions

• Heart Failure
• Overweight and Obesity
• Weight Loss
• Heart Failure With Reduced Ejection Fraction

Interventions

Type	Name	Description
BEHAVIORAL	Full usage of diet management app group and with the full usage of an intelligent weight scale	Subjects will use the fully functional diet management application and an intelligent weight scale with full function designed for obese heart failure patients to help them losed weight and invitigate some important composite cardiovascular endpoint.
BEHAVIORAL	Limited usage of diet management app group and with the limited usage of an intelligent weight scale	Subjects will use the limited function diet management application and an intelligent weight scale with limited function designed for obese heart failure patients as a comparator.

Timeline

• Start date: 2024-06-06
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-06-12
• Last updated: 2025-06-27

Locations

26 sites across 1 country: China