CHDLIGHT-CHDNCT07514611
Weight Loss Via Intelligent Guidance in Patients With Coronary Heart Disease and Obesity: a Randomized Clinical Trial
A study testing dietary regulation and structured exercise training in people with CHD and Overweight or Obese, run by Guangdong Provincial People's Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- CHD, Overweight or Obese
- What is being tested?
- dietary regulation and structured exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2026to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
Ma huan, doctor, 86+17873566991, 978608530@qq.com
About this study
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.
Read the 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
- Being tested
- dietary regulation and structured exercise training
- Keywords
- CHD, overweight or obese
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary regulation and structured exercise trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine Treatment Group | No intervention | Participants do not use the weight loss software and only receive conventional diet and exercise advice for coronary heart disease, with other treatments following local standard protocols. |
| Healthy Weight Loss Group | Experimental | The study formulates a 6-month plan for participants to achieve 10% weight loss. The target is set at 0.5 kg weekly in the first month, followed by a 2% monthly weight reduction until the 10% goal is reached. All participants are provided with a Bluetooth electronic scale to measure fasting body weight every morning, and the data is automatically synchronized to the supporting software for close real-time monitoring. Before intervention, participants receive professional evaluations from cardiologists, dietitians and rehabilitation specialists to develop personalized weight loss regimens, covering CPET, IPAQ and 24-hour dietary recall questionnaires。 Receives: Behavioral: dietary regulation and structured exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: （Baseline）、（1 month）、（3 months）、（6 months）、（12 months）
Secondary outcomes (25)
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.
Measured: Baseline, 6 months
lean body mass
through DEXA (body composition measurement)
Measured: Baseline， 6 months
waist circumference
Waist circumference is measured using a soft ruler.
Measured: Baseline、1 month、3 months、6 months、12 months
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
Measured: Baseline、6 months
Seattle Angina Score
Measured: Baseline、6 months、12 months
quality of life (EQ-5D)
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
Measured: Baseline、6 months、12 months
depression (PHQ-9)
Patient Health Questionnaire-9 (PHQ-9): scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: Baseline、6 months、12 months
anxiety(GAD-7) scores
Generalized Anxiety Disorder-7 (GAD-7): scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms in patients.
Measured: Baseline、6 months、12 months
Apnea-Hypopnea Index
Assessment using a portable sleep monitor，A higher value indicates more frequent apneas and more severe obstructive sleep apnea.
Measured: Baseline、6 months
Pittsburgh Sleep Quality Index
Pittsburgh Sleep Quality Index (PSQI): scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline、6 months、12 months
blood pressure
The average of three seated blood pressure measurements (AHA standard)，Both systolic blood pressure and diastolic blood pressure will be assessed.
Measured: Baseline、1 month、3 months、6 months、12 months
blood lipids
(HDL-C、LDL-C、TC、TG、sdLDL)
Measured: Baseline、6 months
fasting blood glucose
Measured: Baseline、6 months
fasting insulin
Measured: Baseline、6 months
Insulin sensitivity
Insulin sensitivity is assessed using HOMA-IR, with the formula: [(Fasting blood glucose [mmol/L] × Fasting insulin [mIU/L]) / 22.5]
Measured: Baseline、6 months
Left Ventricular Ejection Fraction
cardiac ultrasound
Measured: Baseline、6 months
Left ventricular diastolic function (mitral annular early diastolic velocity e', E/e')
cardiac ultrasound
Measured: Baseline、6 months
grip strength of both hands
It is measured using a dynamometer.
Measured: Baseline、3 months、6 months、12 months
bone mineral density
dual-energy X-ray absorptiometry DXA
Measured: Baseline、6 months
Metabolic syndrome z-score
Metabolic syndrome z-score =（[ 50-HDL）/SDHDL] + （[ TG-150）/SDTG] + [（FBG-100）/SDFBG] + [（WC-88）/SDWC] + [（SBP-130）/SDSBP] + [（DBP-85）
/SDDBP]
Measured: Baseline、6 months
cardiovascular events
eg: myocardial infarction，angina pectoris requiring hospitalization ，heart failure requiring hospitalization ，new-onset atrial fibrillation
Measured: 1 month 、3 months、6 months、12 months
readmission rate
eg: peripheral vascular disease requiring hospitalization ，stroke
Measured: 1 month 、3 months、6 months、12 months
all-cause mortality
Measured: 1 month 、3 months、6 months、12 months
Liver Stiffness Measurement, LSM
Transient Elastography (TE) FibroScan
Measured: Baseline，6months
feces
microbiota analysis
Measured: Baseline，Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start18 Apr 2026 (estimated)
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CHDStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yuebei People's Hospital, Guangzhou Red Cross Hospital, Zhongshan Hospital Of Traditional Chinese Medicine, Shenzhen Nanshan Institute of Chronic Disease Control, Dongguan Binhaiwan Central Hospital, The Eighth People's Hospital of Nanning, People's Hospital of Xinjiang Uygur Autonomous Region, Nanyang Central Hospital, The First People's Hospital of Yunnan, The First People's Hospital of Nanning
- Responsible party
- Principal investigator, Huan Ma, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514611
- Sponsor's protocol ID
- KY2025-972-01
- Acronym
- LIGHT-CHD
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Via Intelligent Guidance in Patients With Coronary Heart Disease and Obesity: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07514611
- Acronym / sponsor ID
- LIGHT-CHD / KY2025-972-01
- Conditions
- CHD, Overweight or Obese
- Keywords
- CHD, overweight or obese
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- Yuebei People's Hospital, Guangzhou Red Cross Hospital, Zhongshan Hospital Of Traditional Chinese Medicine, Shenzhen Nanshan Institute of Chronic Disease Control, Dongguan Binhaiwan Central Hospital, The Eighth People's Hospital of Nanning, People's Hospital of Xinjiang Uygur Autonomous Region, Nanyang Central Hospital, The First People's Hospital of Yunnan, The First People's Hospital of Nanning
- Study start
- 18 Apr 2026 (estimated)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Treatment Group | No intervention | –Participants do not use the weight loss software and only receive conventional diet and exercise advice for coronary heart disease, with other treatments following local standard protocols. |
| Healthy Weight Loss Group | Experimental | Behavioral: dietary regulation and structured exercise trainingThe study formulates a 6-month plan for participants to achieve 10% weight loss. The target is set at 0.5 kg weekly in the first month, followed by a 2% monthly weight reduction until the 10% goal is reached. All participants are provided with a Bluetooth electronic scale to measure fasting body weight every morning, and the data is automatically synchronized to the supporting software for close real-time monitoring. Before intervention, participants receive professional evaluations from cardiologists, dietitians and rehabilitation specialists to develop personalized weight loss regimens, covering CPET, IPAQ and 24-hour dietary recall questionnaires。 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary regulation and structured exercise trainingThis 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. | Behavioural | Healthy Weight Loss Group |
Primary outcome
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.
25 secondary outcomes
Body fat percentage
Time frame: Baseline, 6 months
lean body mass
Time frame: Baseline， 6 months
waist circumference
Time frame: Baseline、1 month、3 months、6 months、12 months
Peak Oxygen Uptake
Time frame: Baseline、6 months
Seattle Angina Score
Time frame: Baseline、6 months、12 months
quality of life (EQ-5D)
Time frame: Baseline、6 months、12 months
depression (PHQ-9)
Time frame: Baseline、6 months、12 months
anxiety(GAD-7) scores
Time frame: Baseline、6 months、12 months
Apnea-Hypopnea Index
Time frame: Baseline、6 months
Pittsburgh Sleep Quality Index
Time frame: Baseline、6 months、12 months
blood pressure
Time frame: Baseline、1 month、3 months、6 months、12 months
blood lipids
Time frame: Baseline、6 months
fasting blood glucose
Time frame: Baseline、6 months
fasting insulin
Time frame: Baseline、6 months
Insulin sensitivity
Time frame: Baseline、6 months
Left Ventricular Ejection Fraction
Time frame: Baseline、6 months
Left ventricular diastolic function (mitral annular early diastolic velocity e', E/e')
Time frame: Baseline、6 months
grip strength of both hands
Time frame: Baseline、3 months、6 months、12 months
bone mineral density
Time frame: Baseline、6 months
Metabolic syndrome z-score
Time frame: Baseline、6 months
cardiovascular events
Time frame: 1 month 、3 months、6 months、12 months
readmission rate
Time frame: 1 month 、3 months、6 months、12 months
all-cause mortality
Time frame: 1 month 、3 months、6 months、12 months
Liver Stiffness Measurement, LSM
Time frame: Baseline，6months
feces
Time frame: Baseline，Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary regulation and structured exercise training in people with CHD and Overweight or Obese, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yuan yu, doctor (86➕17801013954, smileyuyuan@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
body weight (time frame: （Baseline）、（1 month）、（3 months）、（6 months）、（12 months）). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.