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NCT Number: NCT07514611

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location status: Recruiting

Location contact

Ma huan, doctor

CONTACT

[email protected]

86+17873566991

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. body weight

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

    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.

Secondary outcomes

  1. Body fat percentage

    Time frame: Baseline, 6 months

    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.

  2. lean body mass

    Time frame: Baseline, 6 months

    through DEXA (body composition measurement)

  3. waist circumference

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

    Waist circumference is measured using a soft ruler.

  4. Peak Oxygen Uptake

    Time frame: Baseline、6 months

    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

  5. Seattle Angina Score

    Time frame: Baseline、6 months、12 months

  6. quality of life (EQ-5D)

    Time frame: Baseline、6 months、12 months

    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

  7. depression (PHQ-9)

    Time frame: Baseline、6 months、12 months

    Patient Health Questionnaire-9 (PHQ-9): scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.

  8. anxiety(GAD-7) scores

    Time frame: Baseline、6 months、12 months

    Generalized Anxiety Disorder-7 (GAD-7): scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms in patients.

  9. Apnea-Hypopnea Index

    Time frame: Baseline、6 months

    Assessment using a portable sleep monitor,A higher value indicates more frequent apneas and more severe obstructive sleep apnea.

  10. Pittsburgh Sleep Quality Index

    Time frame: Baseline、6 months、12 months

    Pittsburgh Sleep Quality Index (PSQI): scores range from 0 to 21, with higher scores indicating poorer sleep quality.

  11. blood pressure

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

    The average of three seated blood pressure measurements (AHA standard),Both systolic blood pressure and diastolic blood pressure will be assessed.

  12. blood lipids

    Time frame: Baseline、6 months

    (HDL-C、LDL-C、TC、TG、sdLDL)

  13. fasting blood glucose

    Time frame: Baseline、6 months

  14. fasting insulin

    Time frame: Baseline、6 months

  15. Insulin sensitivity

    Time frame: Baseline、6 months

    Insulin sensitivity is assessed using HOMA-IR, with the formula: [(Fasting blood glucose [mmol/L] × Fasting insulin [mIU/L]) / 22.5]

  16. Left Ventricular Ejection Fraction

    Time frame: Baseline、6 months

    cardiac ultrasound

  17. Left ventricular diastolic function (mitral annular early diastolic velocity e', E/e')

    Time frame: Baseline、6 months

    cardiac ultrasound

  18. grip strength of both hands

    Time frame: Baseline、3 months、6 months、12 months

    It is measured using a dynamometer.

  19. bone mineral density

    Time frame: Baseline、6 months

    dual-energy X-ray absorptiometry DXA

  20. Metabolic syndrome z-score

    Time frame: Baseline、6 months

    Metabolic syndrome z-score =([ 50-HDL)/SDHDL] + ([ TG-150)/SDTG] + [(FBG-100)/SDFBG] + [(WC-88)/SDWC] + [(SBP-130)/SDSBP] + [(DBP-85)

    /SDDBP]

  21. cardiovascular events

    Time frame: 1 month 、3 months、6 months、12 months

    eg: myocardial infarction,angina pectoris requiring hospitalization ,heart failure requiring hospitalization ,new-onset atrial fibrillation

  22. readmission rate

    Time frame: 1 month 、3 months、6 months、12 months

    eg: peripheral vascular disease requiring hospitalization ,stroke

  23. all-cause mortality

    Time frame: 1 month 、3 months、6 months、12 months

  24. Liver Stiffness Measurement, LSM

    Time frame: Baseline,6months

    Transient Elastography (TE) FibroScan

  25. feces

    Time frame: Baseline,Six months

    microbiota analysis

Other outcomes

  1. troponin

    Time frame: Baseline、6 months

  2. B-type natriuretic peptide

    Time frame: Baseline、6 months

    Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay.

  3. N-terminal pro-B-type natriuretic peptide

    Time frame: Baseline、6 months

    Measured using chemiluminescent immunoassay or electrochemiluminescent immunoassay.

  4. inflammatory markers

    Time frame: Baseline、6 months

  5. creatinine

    Time frame: Baseline、6 months

  6. alanine transaminase

    Time frame: Baseline、6 months

  7. aspartate transaminase

    Time frame: Baseline、6 months

  8. vitamin D

    Time frame: Baseline、6 months

  9. urea

    Time frame: Baseline、6 months

  10. albumin

    Time frame: Baseline、6 months

  11. prealbumin

    Time frame: Baseline、6 months

  12. electrocardiogram

    Time frame: Baseline、6 months

    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

  13. International Physical Activity Questionnaire - Short Form

    Time frame: Baseline、6 months、12 months

    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.

  14. Perceived Stress Scale

    Time frame: Baseline

    The Perceived Stress Scale (PSS) used the PSS-10 version, with a scoring range of 0-40; higher scores indicate greater perceived stress.

  15. Emotional Skills and Strengths Inventory

    Time frame: Baseline

    The ENRICHD Social Support Instrument (ESSI) has a scoring range of 8-34; higher scores indicate higher social support level.

  16. medication information

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

Study contacts

Contact information is provided by the study sponsor or research team.

li huiyang, graduate student

CONTACT

[email protected]

86+15946983327

yuan yu, doctor

CONTACT

[email protected]

86➕17801013954

Sponsors and collaborators

Lead sponsor

Guangdong Provincial People's Hospital

Other

Collaborators

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

Registry information

Acronym: LIGHT-CHD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 7, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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