Weight Loss Via Intelligent Guidance in Patients With Coronary Heart Disease and Obesity: a Randomized Clinical Trial (LIGHT-CHD)

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.

Study Overview

• Status: Recruiting
• Conditions: CHD; Overweight or Obese
• Intervention / Treatment: Behavioral: dietary regulation and structured exercise training

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.

• Study Type: Interventional
• Enrollment (Estimated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yuan yu, doctor; Phone Number: 86➕17801013954; Email: smileyuyuan@sina.cn
• Study Contact Backup: Name: li huiyang, graduate student; Phone Number: 86+15946983327; Email: 978608530@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Recruiting
      • Guangdong Provincial People's Hospital
      • Contact: Ma huan, doctor; Phone Number: 86+17873566991; Email: 978608530@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Routine Treatment Group; 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.
Experimental: Healthy Weight Loss Group; 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。	Behavioral: dietary 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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）

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
waist circumference	Waist circumference is measured using a soft ruler.	Baseline、1 month、3 months、6 months、12 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
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
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
feces	microbiota analysis	Baseline，Six months
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.	Baseline, 6 months
lean body mass	through DEXA (body composition measurement)	Baseline， 6 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
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
blood lipids	(HDL-C、LDL-C、TC、TG、sdLDL)	Baseline、6 months
fasting blood glucose		Baseline、6 months
fasting insulin		Baseline、6 months
Liver Stiffness Measurement, LSM	Transient Elastography (TE) FibroScan	Baseline，6months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
troponin		Baseline、6 months
B-type natriuretic peptide	Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay.	Baseline、6 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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital
• Collaborators: People's Hospital of Xinjiang Uygur Autonomous Region; Yuebei People's Hospital; The First People's Hospital of Yunnan; Nanyang Central Hospital; Guangzhou Red Cross Hospital; Zhongshan Hospital Of Traditional Chinese Medicine; The First People's Hospital of Nanning; Shenzhen Nanshan Institute of Chronic Disease Control; Dongguan Binhaiwan Central Hospital; The Eighth People's Hospital of Nanning

Study record dates

Study Major Dates

• Study Start (Estimated): April 18, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: CHD; overweight or obese
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: KY2025-972-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No