Diet-management app and smart scale for weight loss in people with heart failure and obesity

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

This tests whether using a diet-management phone app at each meal plus a smart weight scale daily for 12 months helps people with heart failure and obesity live longer, avoid hospital stays, and feel less frail.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 830 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Heart Health Research Center (Academic / other)
• Locations: 26 sites (Beijing, Beijing Municipality and 25 other locations)
• Trial ID: NCT06455878 on ClinicalTrials.gov

What this trial studies

Patients with heart failure and obesity are assigned to use either a fully functional diet-management mobile app plus an intelligent weight scale or a limited-function version of the app and scale. Participants use the app at every meal and step on the scale daily for 12 months, with clinic follow-up at 12 months. The primary outcome is a composite of 1-year all-cause mortality, heart failure hospitalization, and time to first heart failure hospital stay, and secondary outcomes include frailty and quality-of-life measures. Eligibility targets adults with reduced ejection fraction (LVEF ≤50%), NYHA class II–III, BMI ≥26 kg/m² (or elevated waist-to-hip ratio) who can use a smartphone and had a heart failure hospitalization within the past 6 months.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with HFrEF (LVEF ≤50%) in NYHA class II–III, BMI ≥26 kg/m² or elevated waist-to-hip ratio, able to use a smartphone, and with a heart failure hospitalization within the past 6 months.

Not a fit: Patients with end-stage or rapidly worsening heart failure, reversible-cause heart failure, significant anemia (Hb <90 g/L), severe renal impairment (eGFR <30 mL/min/1.73 m²) or on dialysis, or those unable/unwilling to use a smartphone or adhere to daily monitoring are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could reduce deaths and heart failure hospitalizations and improve frailty and quality of life by supporting sustained weight loss and self-management.

How similar studies have performed: App-based weight-loss programs have produced modest weight loss in general populations, but randomized data showing benefit on heart-failure outcomes in HFrEF are lacking, making this application relatively novel for this patient group.

Eligibility criteria

Inclusion Criteria:

1. Age ≥18 years;
2. Left ventricular ejection fraction (LVEF) ≤ 50%, with New York Heart Association (NYHA) class II-III;
3. 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;
4. Ability to use a smartphone and demonstrate compliance via a diet management mobile application during a 2-week ±1-week run-in period;
5. History of heart failure hospitalization within the past 6 months;
6. Signed informed consent.

Exclusion Criteria:

1. End-stage heart failure (≥2 hospitalizations for heart failure in the past 3 months, intolerance to guideline-directed medical therapy (GDMT), or dependence on inotropic agents);
2. Heart failure with reversible causes (e.g., peripartum cardiomyopathy, fulminant myocarditis);
3. Moderate or severe anemia (hemoglobin \[Hb\] \<90 g/L);
4. Renal insufficiency (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²) or ongoing dialysis;
5. Uncontrolled thyroid disease (hyperthyroidism/hypothyroidism) or end-stage liver failure;
6. Alcohol or substance abuse;
7. Current use of weight-loss medications or planned bariatric surgery;
8. Malignancy with an expected survival \<1 year;
9. Conditions potentially hindering protocol compliance, as judged by the investigator (e.g., habitual reliance on food delivery services or company cafeteria meals);
10. Planned hospitalization during the trial period;
11. Concurrent participation in another interventional clinical study.

Where this trial is running

Beijing, Beijing Municipality and 25 other locations

• Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Guangzhou Red Cross Hospital — Guangzhou, Guangdong, China (Recruiting)
• Langfang People's Hospital — Langfang, Hebei, China (Recruiting)
• Jixi City People's Hospital — Jixi, Heilongjiang, China (Recruiting)
• Luoyang No.6 People's Hospital — Luoyang, Henan, China (Recruiting)
• Ruyang County People's Hospital — Luoyang, Henan, China (Recruiting)
• Ningling County People's Hospital — Shangqiu, Henan, China (Recruiting)
• Yongcheng People's Hospital — Shangqiu, Henan, China (Recruiting)
• Shangcheng County People's Hospital — Xinyang, Henan, China (Recruiting)
• Henan Provincial Chest Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Tongliao People's Hospital — Tongliao, Inner Mongolia, China (Recruiting)
• Xiu Yan Manchu Autonomous County Central People's Hospital — Anshan, Liaoning, China (Recruiting)
• Tiemei General Hospital of Liaoning Health Industry Group — Diaobingshancun, Liaoning, China (Not_yet_recruiting)
• Shenyang Tenth Hospital — Shenyang, Liaoning, China (Recruiting)
• Pingdu People's Hospital — Pingdu, Shandong, China (Recruiting)
• Taian First Hospital — Taian, Shandong, China (Recruiting)
• Weihai Central Hospital — Weihai, Shandong, China (Not_yet_recruiting)
• Qin Yuan County People's Hospital — Changzhi, Shanxi, China (Recruiting)
• Xian Red Cross Hospital — Xian, Shanxi, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University, Yulin Branch Hospital — Yulin, Shanxi, China (Recruiting)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, The Xinjiang Uygur Autonomous Region, China (Recruiting)
• Yuhuan Second People's Hospital — Taizhou, Zhejiang, China (Not_yet_recruiting)
• Beijing Chuiyangliu Hospital — Beijing, China (Not_yet_recruiting)
• Beijing Fangshan District First Hospital — Beijing, China (Recruiting)
• Emergency General Hospital — Beijing, China (Not_yet_recruiting)
• Kaifeng Central Hospital — Kaifeng, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Yangyang Zhao

Conditions Heart Failure; Overweight and Obesity; Weight Loss; Heart Failure With Reduced Ejection Fraction