CHD, Overweight or Obese
Conditions
Keywords
CHD, overweight or obese
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALdietary regulation and structured exercise training
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.
Sponsors
Guangdong Provincial People's Hospital
Yuebei People's Hospital
Guangzhou Red Cross Hospital
Zhongshan Hospital Of Traditional Chinese Medicine
Shenzhen Nanshan Institute of Chronic Disease Control
Dongguan Binhaiwan Central Hospital
The Eighth People's Hospital of Nanning
People's Hospital of Xinjiang Uygur Autonomous Region
Nanyang Central Hospital
The First People's Hospital of Yunnan
The First People's Hospital of Nanning
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| body weight | （Baseline）、（1 month）、（3 months）、（6 months）、（12 months） | 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
| Measure | Time frame | Description |
|---|---|---|
| Body fat percentage | Baseline, 6 months | 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 | Baseline， 6 months | through DEXA (body composition measurement) |
| waist circumference | Baseline、1 month、3 months、6 months、12 months | Waist circumference is measured using a soft ruler. |
| Peak Oxygen Uptake | Baseline、6 months | 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 |
| Seattle Angina Score | Baseline、6 months、12 months | — |
| quality of life (EQ-5D) | Baseline、6 months、12 months | 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 |
| depression (PHQ-9) | Baseline、6 months、12 months | Patient Health Questionnaire-9 (PHQ-9): scores range from 0 to 27, with higher scores indicating more severe depressive symptoms. |
| anxiety(GAD-7) scores | Baseline、6 months、12 months | Generalized Anxiety Disorder-7 (GAD-7): scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms in patients. |
| Apnea-Hypopnea Index | Baseline、6 months | Assessment using a portable sleep monitor，A higher value indicates more frequent apneas and more severe obstructive sleep apnea. |
| Pittsburgh Sleep Quality Index | Baseline、6 months、12 months | Pittsburgh Sleep Quality Index (PSQI): scores range from 0 to 21, with higher scores indicating poorer sleep quality. |
| blood pressure | Baseline、1 month、3 months、6 months、12 months | The average of three seated blood pressure measurements (AHA standard)，Both systolic blood pressure and diastolic blood pressure will be assessed. |
| blood lipids | Baseline、6 months | (HDL-C、LDL-C、TC、TG、sdLDL) |
| fasting blood glucose | Baseline、6 months | — |
| fasting insulin | Baseline、6 months | — |
| Insulin sensitivity | Baseline、6 months | Insulin sensitivity is assessed using HOMA-IR, with the formula: \[(Fasting blood glucose \[mmol/L\] × Fasting insulin \[mIU/L\]) / 22.5\] |
| Left Ventricular Ejection Fraction | Baseline、6 months | cardiac ultrasound |
| Left ventricular diastolic function (mitral annular early diastolic velocity e', E/e') | Baseline、6 months | cardiac ultrasound |
| grip strength of both hands | Baseline、3 months、6 months、12 months | It is measured using a dynamometer. |
| bone mineral density | Baseline、6 months | dual-energy X-ray absorptiometry DXA |
| Metabolic syndrome z-score | Baseline、6 months | Metabolic syndrome z-score =（\[ 50-HDL）/SDHDL\] + （\[ TG-150）/SDTG\] + \[（FBG-100）/SDFBG\] + \[（WC-88）/SDWC\] + \[（SBP-130）/SDSBP\] + \[（DBP-85） /SDDBP\] |
| cardiovascular events | 1 month 、3 months、6 months、12 months | eg: myocardial infarction，angina pectoris requiring hospitalization ，heart failure requiring hospitalization ，new-onset atrial fibrillation |
| readmission rate | 1 month 、3 months、6 months、12 months | eg: peripheral vascular disease requiring hospitalization ，stroke |
| all-cause mortality | 1 month 、3 months、6 months、12 months | — |
| Liver Stiffness Measurement, LSM | Baseline，6months | Transient Elastography (TE) FibroScan |
| feces | Baseline，Six months | microbiota analysis |
Countries
China
Contacts
CONTACTyuan yu, doctor
CONTACTli huiyang, graduate student
Outcome results
None listed