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RECRUITING

NCT07514611

Weight Loss Via Intelligent Guidance in Patients With Coronary Heart Disease and Obesity: a Randomized Clinical Trial

Sponsor: Guangdong Provincial People's Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-04-18

Completion Date

2028-12-31

Last Updated

2026-04-07

Healthy Volunteers

Conditions

CHD Overweight or Obese

Interventions

BEHAVIORAL

Personalized Diet and Exercise Intervention

Intervention for Healthy Weight Loss Pre-intervention assessment: Participants undergo comprehensive evaluations by cardiologists, dietitians, and rehabilitation specialists, including cardiopulmonary exercise testing, IPAQ (International Physical Activity Questionnaire), and 24-hour dietary recall, to tailor the 6-month plan (targeting 10% weight loss, with 0.5kg/week in the first month and 2% monthly thereafter). Personalized diet: Target energy intake is calculated using the Harris-Benedict formula (adjusted for gender). Three specific macronutrient ratios are available (e.g., energy-restricted low-fat high-protein diet), with software generating customized meal plans. Participants upload daily food photos for software analysis and real-time evaluation reports . Individualized exercise: Aerobic exercise starts with 150-300 minutes/week of moderate-intensity or 75-150 minutes/week of high-intensity activity, progressing to 300 minutes/week moderate or 150 minutes/week high-intensity,

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.

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China