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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Yangyang Zhao
• Email: zhao.yangyang@hhresearch.cn
• Phone: +8618513340674

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.