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

Plain English Summary

Weight Loss Via Intelligent Guidance in Patients With Coronary Heart Disease and Obesity: a Randomized Clinical Trial is a Not Applicable clinical trial sponsored by Guangdong Provincial People's Hospital studying CHD, Overweight or Obese. This study tests a digital program that provides personalized diet and exercise advice to help people with heart disease lose weight. It is for adults aged 18-65 who have coronary heart disease and are overweight or obese. Participants will use a smartphone app for guidance and will have regular check-ups over 1 year. Standard care for heart disease and obesity management is the alternative. The trial aims to enroll 140 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 65 years old and have been diagnosed with coronary heart disease and have a BMI of 28 or higher. You must be willing to lose weight, be able to use a smartphone, and manage daily activities on your own. You cannot join if you have had a recent heart attack or unstable angina, have certain other serious health conditions (like cancer, severe kidney/liver problems, or severe mental health issues), have had weight loss surgery, or are pregnant or breastfeeding. This trial is studying CHD, Overweight or Obese, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The main goal is to see how much weight participants lose over 12 months, which can lead to better heart health and fewer complications. The specific primary outcome measures are: body weight (（Baseline）、（1 month）、（3 months）、（6 months）、（12 months）). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.

Why This Trial Matters

This trial aims to improve the health of obese patients with coronary heart disease by using a digital tool to guide weight loss, addressing a major cause of death worldwide. This research targets CHD, Overweight or Obese, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in managing cardiovascular disease, a large market. Success could lead to a scalable digital health solution for a common comorbidity, potentially attractin

Is This Trial Right for Me?

Ask your doctor if this trial is right for you, especially regarding your heart condition and any other health issues. Be prepared to follow a personalized diet and exercise plan guided by a smartphone app for a year. You will have regular check-ups to monitor your progress and health. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 140 participants

Interventions

• 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

Primary Outcomes

• body weight (（Baseline）、（1 month）、（3 months）、（6 months）、（12 months）)

Secondary Outcomes

• liver fat mass (Baseline, 6 months)
• lean body mass (Baseline and 6 months)
• waist circumference (Baseline、1 month、3 months、6 months、12 months)
• Peak Oxygen Uptake (Baseline、3 months、6 months、12 months)
• Seattle Angina Score (Baseline、6 months、12 months)

Full Eligibility Criteria

Inclusion Criteria:

1. Age range: 18-65 years old .
2. 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).
3. BMI: Body Mass Index (BMI) ≥ 28 kg/m²
4. Weight loss willingness: Has the intention to lose weight
5. Smartphone proficiency: Able to use a smartphone.
6. Daily living ability: Capable of performing basic activities of daily living independently.
7. Informed consent: Voluntarily participates in the study, signs a written informed consent form, and is willing to cooperate with follow-up

Exclusion Criteria:

1. Unstable angina pectoris or acute myocardial infarction occurring within the previous month;
2. 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;
3. Comorbid diseases that affect exercise capacity, such as severe cardiopulmonary diseases or osteoarthritic conditions;
4. Comorbid diseases that affect diet, such as severe mental disorders, bulimia or anorexia nervosa, or cognitive dysfunction;
5. 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;
6. Severe language, psychological, or physical disabilities that prevent participation in the protocol;
7. Pregnant or lactating women, or individuals of childbearing potential who are unwilling/unable to use effective contraceptive measures;
8. Participation in other interventional clinical trials;
9. Body weight change exceeding 5% within the past year;
10. 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);
11. Patients deemed unsuitable for participation in the study by the researchers.

Trial Locations

• Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China

Frequently Asked Questions

Related Conditions

• Coronary Heart Disease
• Obesity
• Overweight
• Hypertension
• Diabetes Mellitus
• Dyslipidemia
• Metabolic Syndrome
• Cardiovascular Disease
• Heart Failure
• Myocardial Infarction

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