NCT07514611

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CHD
• Overweight or Obese

Interventions

Type	Name	Description
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,

Timeline

• Start date: 2026-04-18
• Primary completion: 2027-08-31
• Completion: 2028-12-31
• First posted: 2026-04-07
• Last updated: 2026-04-07

Locations

1 site across 1 country: China