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| Name | Class |
|---|---|
| Yuebei People's Hospital | OTHER |
| Guangzhou Red Cross Hospital | OTHER |
| Zhongshan Hospital Of Traditional Chinese Medicine | OTHER |
| Shenzhen Nanshan Institute of Chronic Disease Control |
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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.
Healthy Weight Loss Group: Routine care + personalized diet and exercise intervention Routine Treatment Group: Routine care Specific Treatment Measures Selected in This Study Patients randomly assigned to the weight loss group need to undergo evaluations by professional cardiologists, dietitians, and rehabilitation specialists before receiving weight loss intervention. A personalized weight loss plan is developed based on the evaluation results.
The study sets a goal of 10% weight loss within 6 months for patients in the weight loss group, with diet and exercise interventions implemented via software. The daily target energy intake is calculated using the formula (Basal Energy Expenditure * 1.3 - 500 kcal). The software generates personalized meal plans for patients based on energy and nutrient ratios.
At the start of the intervention, all participants in the intervention group receive a training session. This session guides them on conducting appropriate resistance exercises and aerobic training. An exercise plan is tailored to each patient according to their physical function level, following the principles of progressiveness and individualization.
Patients randomly assigned to the control group do not have the weight loss software installed during the study period. They only receive routine dietary and exercise advice for coronary heart disease patients. All other treatments follow local routine clinical practices.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine Treatment Group | No Intervention | Participants do not use the weight loss software and only receive conventional diet and exercise advice for coronary heart disease, with other treatments following local standard protocols. | |
| Healthy Weight Loss Group | Experimental | The study formulates a 6-month plan for participants to achieve 10% weight loss. The target is set at 0.5 kg weekly in the first month, followed by a 2% monthly weight reduction until the 10% goal is reached. All participants are provided with a Bluetooth electronic scale to measure fasting body weight every morning, and the data is automatically synchronized to the supporting software for close real-time monitoring. Before intervention, participants receive professional evaluations from cardiologists, dietitians and rehabilitation specialists to develop personalized weight loss regimens, covering CPET, IPAQ and 24-hour dietary recall questionnaires。 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dietary regulation and structured exercise training | Behavioral | This 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | （Baseline）、（1 month）、（3 months）、（6 months）、（12 months） |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| troponin | Baseline、6 months | |
| B-type natriuretic peptide | Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay. | Baseline、6 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yuan yu, doctor | Contact | 86➕17801013954 | smileyuyuan@sina.cn | |
| li huiyang, graduate student | Contact | 86+15946983327 | 978608530@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| UNKNOWN |
| Dongguan Binhaiwan Central Hospital | UNKNOWN |
| The Eighth People's Hospital of Nanning | UNKNOWN |
| People's Hospital of Xinjiang Uygur Autonomous Region | OTHER |
| Nanyang Central Hospital | OTHER |
| The First People's Hospital of Yunnan | OTHER |
| The First People's Hospital of Nanning | UNKNOWN |
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| Baseline, 6 months |
| lean body mass | through DEXA (body composition measurement) | Baseline， 6 months |
| waist circumference | Waist circumference is measured using a soft ruler. | Baseline、1 month、3 months、6 months、12 months |
| 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 | Baseline、6 months |
| Seattle Angina Score | Baseline、6 months、12 months |
| quality of life (EQ-5D) | For the EuroQol 5-Dimension (EQ-5D) utility score and visual analogue scale (VAS) score, a higher score indicates a higher health-related quality of life | Baseline、6 months、12 months |
| depression (PHQ-9) | Patient Health Questionnaire-9 (PHQ-9): scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. | Baseline、6 months、12 months |
| anxiety(GAD-7) scores | Generalized Anxiety Disorder-7 (GAD-7): scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms in patients. | Baseline、6 months、12 months |
| Apnea-Hypopnea Index | Assessment using a portable sleep monitor，A higher value indicates more frequent apneas and more severe obstructive sleep apnea. | Baseline、6 months |
| Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index (PSQI): scores range from 0 to 21, with higher scores indicating poorer sleep quality. | Baseline、6 months、12 months |
| blood pressure | The average of three seated blood pressure measurements (AHA standard)，Both systolic blood pressure and diastolic blood pressure will be assessed. | Baseline、1 month、3 months、6 months、12 months |
| blood lipids | (HDL-C、LDL-C、TC、TG、sdLDL) | Baseline、6 months |
| fasting blood glucose | Baseline、6 months |
| fasting insulin | Baseline、6 months |
| Insulin sensitivity | Insulin sensitivity is assessed using HOMA-IR, with the formula: [(Fasting blood glucose [mmol/L] × Fasting insulin [mIU/L]) / 22.5] | Baseline、6 months |
| Left Ventricular Ejection Fraction | cardiac ultrasound | Baseline、6 months |
| Left ventricular diastolic function (mitral annular early diastolic velocity e', E/e') | cardiac ultrasound | Baseline、6 months |
| grip strength of both hands | It is measured using a dynamometer. | Baseline、3 months、6 months、12 months |
| bone mineral density | dual-energy X-ray absorptiometry DXA | Baseline、6 months |
| Metabolic syndrome z-score | Metabolic syndrome z-score =（[ 50-HDL）/SDHDL] + （[ TG-150）/SDTG] + [（FBG-100）/SDFBG] + [（WC-88）/SDWC] + [（SBP-130）/SDSBP] + [（DBP-85） /SDDBP] | Baseline、6 months |
| cardiovascular events | eg: myocardial infarction，angina pectoris requiring hospitalization ，heart failure requiring hospitalization ，new-onset atrial fibrillation | 1 month 、3 months、6 months、12 months |
| readmission rate | eg: peripheral vascular disease requiring hospitalization ，stroke | 1 month 、3 months、6 months、12 months |
| all-cause mortality | 1 month 、3 months、6 months、12 months |
| Liver Stiffness Measurement, LSM | Transient Elastography (TE) FibroScan | Baseline，6months |
| feces | microbiota analysis | Baseline，Six months |
| N-terminal pro-B-type natriuretic peptide | Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay. | Baseline、6 months |
| inflammatory markers | Baseline、6 months |
| creatinine | Baseline、6 months |
| alanine transaminase | Baseline、6 months |
| aspartate transaminase | Baseline、6 months |
| vitamin D | Baseline、6 months |
| urea | Baseline、6 months |
| albumin | Baseline、6 months |
| prealbumin | Baseline、6 months |
| electrocardiogram | Heart rate, heart rhythm, P wave, PR interval, QRS complex, QT interval / QTc interval, ST segment, T wave, presence or absence of arrhythmia and conduction abnormalities | Baseline、6 months |
| International Physical Activity Questionnaire - Short Form | The International Physical Activity Questionnaire-Short Form (IPAQ-SF) was used to assess physical activity level, with results expressed as MET-min/week or categorized into low, moderate, and high physical activity levels; higher scores indicate higher physical activity level. | Baseline、6 months、12 months |
| Perceived Stress Scale | The Perceived Stress Scale (PSS) used the PSS-10 version, with a scoring range of 0-40; higher scores indicate greater perceived stress. | Baseline |
| Emotional Skills and Strengths Inventory | The ENRICHD Social Support Instrument (ESSI) has a scoring range of 8-34; higher scores indicate higher social support level. | Baseline |
| medication information | Baseline、1 month、3 months、6 months、12 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |