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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 parti

Первичные конечные точки

• body weight [Срок оценки: （Baseline）、（1 month）、（3 months）、（6 months）、（12 months）]

Вторичные конечные точки (12)

• Body fat percentage [Срок оценки: Baseline, 6 months]
• lean body mass [Срок оценки: Baseline， 6 months]
• waist circumference [Срок оценки: Baseline、1 month、3 months、6 months、12 months]
• Peak Oxygen Uptake [Срок оценки: Baseline、6 months]
• Seattle Angina Score [Срок оценки: Baseline、6 months、12 months]
• quality of life (EQ-5D) [Срок оценки: Baseline、6 months、12 months]
• depression (PHQ-9) [Срок оценки: Baseline、6 months、12 months]
• anxiety(GAD-7) scores [Срок оценки: Baseline、6 months、12 months]
• Apnea-Hypopnea Index [Срок оценки: Baseline、6 months]
• Pittsburgh Sleep Quality Index [Срок оценки: Baseline、6 months、12 months]
• blood pressure [Срок оценки: Baseline、1 month、3 months、6 months、12 months]
• blood lipids [Срок оценки: Baseline、6 months]

Критерии участия

Критерии включения

• Age range: 18-65 years old .
• 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).
• BMI: Body Mass Index (BMI) ≥ 28 kg/m²
• Weight loss willingness: Has the intention to lose weight
• Smartphone proficiency: Able to use a smartphone.
• Daily living ability: Capable of performing basic activities of daily living independently.
• Informed consent: Voluntarily participates in the study, signs a written informed consent form, and is willing to cooperate with follow-up

Критерии исключения

• Unstable angina pectoris or acute myocardial infarction occurring within the previous month;
• 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;
• Comorbid diseases that affect exercise capacity, such as severe cardiopulmonary diseases or osteoarthritic conditions;
• Comorbid diseases that affect diet, such as severe mental disorders, bulimia or anorexia nervosa, or cognitive dysfunction;
• 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;
• Severe language, psychological, or physical disabilities that prevent participation in the protocol;
• Pregnant or lactating women, or individuals of childbearing potential who are unwilling/unable to use effective contraceptive measures;
• Participation in other interventional clinical trials;
• Body weight change exceeding 5% within the past year;
• 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);
• Patients deemed unsuitable for participation in the study by the researchers.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Guangdong Provincial People's Hospital — Гуанчжоу

Идентификаторы

NCT: NCT07514611 · KY2025-972-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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