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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangdong Provincial People's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • dietary regulation and structured exercise training

    Behavioral

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: Routine Treatment GroupNo intervention 0 interventions
Group B: Healthy Weight Loss GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
(Baseline)、(1 month)、(3 months)、(6 months)、(12 months)

Secondary outcomes

1

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.

Time frame
Baseline, 6 months
2

lean body mass

through DEXA (body composition measurement)

Time frame
Baseline, 6 months
3

waist circumference

Waist circumference is measured using a soft ruler.

Time frame
Baseline、1 month、3 months、6 months、12 months
4

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

Time frame
Baseline、6 months

Other outcomes

1

troponin

Time frame
Baseline、6 months
2

B-type natriuretic peptide

Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay.

Time frame
Baseline、6 months
3

N-terminal pro-B-type natriuretic peptide

Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay.

Time frame
Baseline、6 months
4

inflammatory markers

Time frame
Baseline、6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Guangdong Provincial People's Hospital

Lead sponsor

Yuebei People's Hospital

Collaborator

Guangzhou Red Cross Hospital

Collaborator

Zhongshan Hospital Of Traditional Chinese Medicine

Collaborator

Shenzhen Nanshan Institute of Chronic Disease Control

Collaborator

Dongguan Binhaiwan Central Hospital

Collaborator

The Eighth People's Hospital of Nanning

Collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

Collaborator

Nanyang Central Hospital

Collaborator

The First People's Hospital of Yunnan

Collaborator

The First People's Hospital of Nanning

Collaborator