About this trial
Coronary Heart Disease (CHD) is an ischemic heart disease caused by coronary atherosclerosis, and it is the leading cause of death from cardiovascular diseases worldwide. Weight loss in obese patients can significantly improve metabolic indicators such as dyslipidemia and insulin resistance; therefore, weight loss may become a target for improving the prognosis of obese patients with coronary heart disease. This study is a multicenter, randomized controlled clinical trial aimed at evaluating the effect of software-based healthy weight loss guidance (personalized diet + exercise intervention) in obese patients with coronary heart disease. It is expected that 136 patients will be enrolled in hospitals including Guangdong Provincial People's Hospital, with a total study duration of 1 year.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age range: 18-65 years old .
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).
BMI: Body Mass Index (BMI) ≥ 28 kg/m²
Weight loss willingness: Has the intention to lose weight
Disqualifiers
Unstable angina pectoris or acute myocardial infarction occurring within the previous month;
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;
Comorbid diseases that affect exercise capacity, such as severe cardiopulmonary diseases or osteoarthritic conditions;
Comorbid diseases that affect diet, such as severe mental disorders, bulimia or anorexia nervosa, or cognitive dysfunction;
Trial design
Parallel
Treatments tested in this trial
dietary regulation and structured exercise training
BehavioralThis study implements a personalized intervention combining dietary regulation, exercise training, safety protocols, and adherence assessment. Dietary intervention: Target energy intake = basal energy expenditure×1.3-500kcal; basal energy expenditure is estimated via gender-specific Harris-Benedict formula (0.9 correction), ideal weight by height and BMI 24.9. Macronutrient ratios are selected based on comorbidities and baseline indicators; software generates personalized meal plans, with participants uploading daily food photos for calorie/nutrient analysis and reports. Exercise intervention: Standardized guidance and progressive prescriptions are provided. Aerobic intensity (CPET-determined anaerobic threshold heart rate±10) involves ultra-slow jogging/brisk walking (150-180 steps/min, RPE 10-12), 30-40min core training +10min warm-up/cool-down, ≥5 times/week. Elastic band resistance training (≥3 times/week) uses video guidance.
Treatment groups
Trial outcomes
Primary outcomes
body weight
The intervention group received a Bluetooth electronic scale for daily morning fasting weighing, and the measurement results will be synchronized to the software to monitor the weight situation.
Secondary outcomes
Body fat percentage
Body fat percentage (BFP) refers to the proportion of total body weight composed of fat mass, including essential fat and storage fat. It is a key anthropometric indicator for evaluating obesity level, metabolic health risk, and the efficacy of weight loss and lifestyle intervention. Bioelectrical Impedance Analysis (BIA) Most commonly used via smart body fat scales and body composition analyzers for routine clinical and home monitoring.
lean body mass
through DEXA (body composition measurement)
waist circumference
Waist circumference is measured using a soft ruler.
Peak Oxygen Uptake
Peak oxygen consumption is an important indicator reflecting cardiopulmonary function, measured by cardiopulmonary exercise testing, to evaluate the effect of intervention on improving cardiopulmonary function in obese patients with coronary heart disease
Other outcomes
troponin
B-type natriuretic peptide
Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay.
N-terminal pro-B-type natriuretic peptide
Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay.
inflammatory markers
Sponsors and contacts
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Guangdong Provincial People's Hospital
Lead sponsor
Yuebei People's Hospital
Collaborator
Guangzhou Red Cross Hospital
Collaborator
Zhongshan Hospital Of Traditional Chinese Medicine
Collaborator
Shenzhen Nanshan Institute of Chronic Disease Control
Collaborator
Dongguan Binhaiwan Central Hospital
Collaborator
The Eighth People's Hospital of Nanning
Collaborator
People's Hospital of Xinjiang Uygur Autonomous Region
Collaborator
Nanyang Central Hospital
Collaborator
The First People's Hospital of Yunnan
Collaborator
The First People's Hospital of Nanning
Collaborator