Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Location status: Recruiting
NCT Number: NCT07514611
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Guangzhou, Guangdong, 510080, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: (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.
Time frame: 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.
Time frame: Baseline, 6 months
through DEXA (body composition measurement)
Time frame: Baseline、1 month、3 months、6 months、12 months
Waist circumference is measured using a soft ruler.
Time frame: 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
Time frame: Baseline、6 months、12 months
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Baseline、6 months
Assessment using a portable sleep monitor,A higher value indicates more frequent apneas and more severe obstructive sleep apnea.
Time frame: Baseline、6 months、12 months
Pittsburgh Sleep Quality Index (PSQI): scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: 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.
Time frame: Baseline、6 months
(HDL-C、LDL-C、TC、TG、sdLDL)
Time frame: Baseline、6 months
Time frame: Baseline、6 months
Time frame: Baseline、6 months
Insulin sensitivity is assessed using HOMA-IR, with the formula: [(Fasting blood glucose [mmol/L] × Fasting insulin [mIU/L]) / 22.5]
Time frame: Baseline、6 months
cardiac ultrasound
Time frame: Baseline、6 months
cardiac ultrasound
Time frame: Baseline、3 months、6 months、12 months
It is measured using a dynamometer.
Time frame: Baseline、6 months
dual-energy X-ray absorptiometry DXA
Time frame: 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]
Time frame: 1 month 、3 months、6 months、12 months
eg: myocardial infarction,angina pectoris requiring hospitalization ,heart failure requiring hospitalization ,new-onset atrial fibrillation
Time frame: 1 month 、3 months、6 months、12 months
eg: peripheral vascular disease requiring hospitalization ,stroke
Time frame: 1 month 、3 months、6 months、12 months
Time frame: Baseline,6months
Transient Elastography (TE) FibroScan
Time frame: Baseline,Six months
microbiota analysis
Time frame: Baseline、6 months
Time frame: Baseline、6 months
Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay.
Time frame: Baseline、6 months
Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay.
Time frame: Baseline、6 months
Time frame: Baseline、6 months
Time frame: Baseline、6 months
Time frame: Baseline、6 months
Time frame: Baseline、6 months
Time frame: Baseline、6 months
Time frame: Baseline、6 months
Time frame: Baseline、6 months
Time frame: Baseline、6 months
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
Time frame: Baseline、6 months、12 months
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.
Time frame: Baseline
The Perceived Stress Scale (PSS) used the PSS-10 version, with a scoring range of 0-40; higher scores indicate greater perceived stress.
Time frame: Baseline
The ENRICHD Social Support Instrument (ESSI) has a scoring range of 8-34; higher scores indicate higher social support level.
Time frame: Baseline、1 month、3 months、6 months、12 months
Contact information is provided by the study sponsor or research team.
li huiyang, graduate student
CONTACT
86+15946983327
yuan yu, doctor
CONTACT
86➕17801013954
Guangdong Provincial People's Hospital
Other
Acronym: LIGHT-CHD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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