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

Status: Recruiting
Location: See all (26) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Age ≥18 years;

• Left ventricular ejection fraction (LVEF) ≤ 50%, with New York Heart Association (NYHA) class II-III;

• Body mass index (BMI) ≥ 26 kg/m² or male waist-to-hip ratio (WHR=waist circumference/hip circumference) ≥ 0.9, female waist-to-hip ratio ≥ 0.85;

• Ability to use a smartphone and demonstrate compliance via a diet management mobile application during a 2-week ±1-week run-in period;

• History of heart failure hospitalization within the past 6 months;

• Signed informed consent.

Locations
Other Locations
China
Xiu Yan Manchu Autonomous County Central People's Hospital
RECRUITING
Anshan
Beijing Anzhen Hospital
RECRUITING
Beijing
Beijing Chuiyangliu Hospital
NOT_YET_RECRUITING
Beijing
Beijing Fangshan District First Hospital
RECRUITING
Beijing
Emergency General Hospital
NOT_YET_RECRUITING
Beijing
Qin Yuan County People's Hospital
RECRUITING
Changzhi
Tiemei General Hospital of Liaoning Health Industry Group
NOT_YET_RECRUITING
Diaobingshancun
Guangzhou Red Cross Hospital
RECRUITING
Guangzhou
Jixi City People's Hospital
RECRUITING
Jixi
Kaifeng Central Hospital
NOT_YET_RECRUITING
Kaifeng
Langfang People's Hospital
RECRUITING
Langfang
Luoyang No.6 People's Hospital
RECRUITING
Luoyang
Ruyang County People's Hospital
RECRUITING
Luoyang
Pingdu People's Hospital
RECRUITING
Pingdu
Ningling County People's Hospital
RECRUITING
Shangqiu
Yongcheng People's Hospital
RECRUITING
Shangqiu
Shenyang Tenth Hospital
RECRUITING
Shenyang
Taian First Hospital
RECRUITING
Taian
Yuhuan Second People's Hospital
NOT_YET_RECRUITING
Taizhou
Tongliao People's Hospital
RECRUITING
Tongliao
The First Affiliated Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Weihai Central Hospital
NOT_YET_RECRUITING
Weihai
Xian Red Cross Hospital
RECRUITING
Xian
Shangcheng County People's Hospital
RECRUITING
Xinyang
The First Affiliated Hospital of Xi'an Jiaotong University, Yulin Branch Hospital
RECRUITING
Yulin
Henan Provincial Chest Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Yangyang Zhao
zhao.yangyang@hhresearch.cn
+8618513340674
Time Frame
Start Date: 2024-06-06
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 830
Treatments
Experimental: Full usage of diet management app group and with the full usage of an intelligent weight scale
Full usage of the diet management app means subjects can use all functions of the application (including personal information, food record, weight record, exercise record, step count, daily dietary intake, distribution and analysis of dietary structure, and recommended foods and their structural distribution).~Full usage of the intelligent weight scale means subjects can use all functions of the scale (including the report of heart rate, total body water, body fat rate, muscle mass, protein mass, bone mass, visceral fat index, basal metabolic rate, subcutaneous fat rate, and skeletal muscle rate).
Active_comparator: Limited usage of diet management app group and with the limited usage of an intelligent weight scale
Limited usage of the diet management app means subjects can use some functions of the application (including personal information, food record, weight record, exercise record, and step count).~Limited usage of the intelligent weight scale means subjects can use a few functions of the scale (including the weight record, lower limb impedance value, and BMI).
Related Therapeutic Areas
Sponsors
Leads: Heart Health Research Center

This content was sourced from clinicaltrials.gov