Smartphone-guided weight loss program for people with coronary heart disease and obesity

Weight Loss Via Intelligent Guidance in Patients With Coronary Heart Disease and Obesity: a Randomized Clinical Trial

This project tests whether a smartphone-delivered personalized diet and exercise program helps adults with coronary heart disease and obesity lose weight and improve heart-related health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Guangdong Provincial People's Hospital (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07514611 on ClinicalTrials.gov

What this trial studies

This is a multicenter, randomized controlled trial enrolling about 136 patients over one year to compare software-based personalized diet and exercise guidance versus routine care. Participants in the intervention arm receive baseline evaluations by cardiology, dietetics, and rehabilitation specialists and a tailored plan delivered via an app with a target of 10% weight loss in six months. Daily energy targets are calculated (BEE * 1.3 - 500 kcal) and the software produces individualized meal plans and progressive exercise prescriptions after initial training in resistance and aerobic training. Control participants receive routine dietary and exercise advice without the weight-loss software, and all other clinical care follows local practice.

Who should consider this trial

Good fit: Adults aged 18–65 with confirmed coronary heart disease, BMI ≥ 28 kg/m², willingness to lose weight, ability to use a smartphone, and capacity for basic activities of daily living are eligible.

Not a fit: Patients with unstable angina or myocardial infarction within the past month, major comorbidities (such as active cancer, serious endocrine or neurological disease), prior bariatric surgery, or inability/unwillingness to use a smartphone or perform prescribed exercise may not benefit from this intervention.

Why it matters

Potential benefit: If successful, the program could help patients achieve clinically meaningful weight loss, improve lipid and insulin resistance markers, and potentially lower cardiac risk.

How similar studies have performed: Lifestyle and digital weight-loss programs have previously reduced weight and cardiometabolic risk, but randomized trials specifically testing a software-delivered personalized diet-and-exercise program in people with established coronary heart disease are limited.

Eligibility criteria

Inclusion Criteria:

1. Age range: 18-65 years old .
2. History of coronary heart disease confirmed by coronary angiography or coronary CTA, showing ≥50% stenosis in at least one major coronary artery (left main coronary artery, left anterior descending artery, left circumflex artery, right coronary artery); or a definite history of myocardial infarction, or prior coronary revascularization (PCI or CABG).
3. BMI: Body Mass Index (BMI) ≥ 28 kg/m²
4. Weight loss willingness: Has the intention to lose weight
5. Smartphone proficiency: Able to use a smartphone.
6. Daily living ability: Capable of performing basic activities of daily living independently.
7. Informed consent: Voluntarily participates in the study, signs a written informed consent form, and is willing to cooperate with follow-up

Exclusion Criteria:

1. Unstable angina pectoris or acute myocardial infarction occurring within the previous month;
2. Comorbid endocrine or neurological diseases, cancer, or a history of bariatric surgery that affect body weight; or long-term use of medications that impact body weight;
3. Comorbid diseases that affect exercise capacity, such as severe cardiopulmonary diseases or osteoarthritic conditions;
4. Comorbid diseases that affect diet, such as severe mental disorders, bulimia or anorexia nervosa, or cognitive dysfunction;
5. Significant liver or kidney dysfunction, defined as: glomerular filtration rate \< 60 ml/(min·1.73m²) or undergoing dialysis; alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 times the upper limit of the normal range specified by the research center;
6. Severe language, psychological, or physical disabilities that prevent participation in the protocol;
7. Pregnant or lactating women, or individuals of childbearing potential who are unwilling/unable to use effective contraceptive measures;
8. Participation in other interventional clinical trials;
9. Body weight change exceeding 5% within the past year;
10. Patients with a habit of long-term high-intensity exercise(more than 2 sessions per week of high-intensity endurance training, or more than 3 sessions per week of moderate-intensity endurance training);
11. Patients deemed unsuitable for participation in the study by the researchers.

Where this trial is running

Guangzhou, Guangdong

• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: yuan yu, doctor

Conditions: CHD, Overweight or Obese, overweight or obese