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

NCT07514611 | Recruiting

• 1 other identifier: KY2025-972-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

CHD; Overweight or Obese

Keywords

CHD; overweight or obese

Outcome Measures

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.

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

Secondary Outcomes (25)

• Body fat percentage

  Baseline, 6 months

• lean body mass

  Baseline， 6 months

• waist circumference

  Baseline、1 month、3 months、6 months、12 months

• Peak Oxygen Uptake

  Baseline、6 months

• Seattle Angina Score

  Baseline、6 months、12 months

Other Outcomes (16)

• troponin

  Baseline、6 months

• B-type natriuretic peptide

  Baseline、6 months

• N-terminal pro-B-type natriuretic peptide

  Baseline、6 months

Study Arms (2)

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。

Behavioral: dietary regulation and structured exercise training

Interventions

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.

Healthy Weight Loss Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead
• 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
• Nanyang Central Hospital: collaborator
• Dongguan Binhaiwan Central Hospital: collaborator
• The Eighth People's Hospital of Nanning: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• The First People's Hospital of Yunnan: collaborator
• The First People's Hospital of Nanning: collaborator

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

yuan yu, doctor

CONTACT

86➕17801013954; smileyuyuan@sina.cn

li huiyang, graduate student

CONTACT

86+15946983327; 978608530@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guangdong Provincial People's Hospital

Study Record Dates

• First Submitted: March 10, 2026
• First Posted: April 7, 2026
• Study Start: April 18, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)