Adaptive Behavioral Intervention Application for Weight Control in Obese/Overweight Endometrial Cancer Patients in Fertility Preservation:A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Body mass index (BMI)
研究概览
简要总结
This study is a single-center, prospective, randomized controlled trial targeting endometrial cancer (EC) patients undergoing fertility-sparing treatment at Peking University People's Hospital from March 2025 to March 2027. The aim is to evaluate the efficacy of an intelligent mobile application (APP) based on the Adaptive Behavioral Intervention (ABI) framework in weight management for obese or overweight endometrial cancer patients receiving fertility preservation therapy. Additionally, the study seeks to explore its potential advantages in improving body mass index (BMI), tumor regression, and glucose and lipid metabolism profiles.
详细描述
Endometrial cancer is one of the most common malignancies of the female reproductive tract, with obesity being a closely associated factor in its development and progression. According to the American Cancer Society, 57% of endometrial cancer cases are linked to obesity, and a 5-unit increase in body mass index (BMI) elevates the risk of EC by 50%. Overweight or obesity adversely impacts treatment efficacy and reduces survival rates in EC patients. In recent years, the incidence of EC has shown a trend toward younger populations, posing significant threats to the health and quality of life of patients undergoing fertility-sparing treatment. The Adaptive Behavioral Intervention (ABI) framework emphasizes real-time adjustments based on individual feedback and progress to optimize behavioral change and health outcomes. Integrating smart application (APP) technology can provide more convenient and personalized weight management support for EC patients undergoing fertility preservation. By continuously collecting and analyzing behavioral data, the intervention strategy can be dynamically tailored, thereby enhancing the effectiveness and sustainability of the intervention. Currently, there is a paucity of research on comprehensive weight management interventions incorporating intelligent APPs for obese or overweight EC patients in fertility-sparing treatment. This study aims to investigate the efficacy of an ABI-based smart APP in weight management for this population through a randomized controlled trial (RCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •BMI ≥ 25 kg/m²
- •Histologically confirmed endometrial carcinoma via diagnostic curettage, hysteroscopic endometrial biopsy, or needle biopsy
- •Clinical FIGO 2009 stage IA disease: No evidence of extrauterine metastasis or myometrial invasion on imaging (MRI/CT)
- •ECOG < 2
- •Active desire to preserve fertility
- •Fertility-preserving treatment
- •Willingness to participate and signed informed consent
排除标准
- •High-grade or p53-mutated (p53mut) endometrial cancer
- •Currently using weight-loss medications
- •Pregnant or breastfeeding
- •Presence of communication barriers that prevent understanding and participation in the informed consent process
- •Participation in other weight-loss programs
- •Inability to safely engage in unsupervised physical activities
- •Undergoing anticoagulant therapy that may affect body composition, weight, or energy expenditure
- •Severe comorbidities: urinary system stones, history of renal failure or severe renal insufficiency, familial dyslipidemia, severe liver disease, chronic metabolic acidosis, history of pancreatitis, severe diabetes, active gallbladder disease, fat malabsorption, severe cardiovascular and cerebrovascular diseases
- •Presence of unstable medical conditions: uncontrolled hypertension, diabetes, unstable angina, transient ischemic attack, other cancers currently under treatment, Crohn's disease
研究组 & 干预措施
Experimental Group
① Implementation of the DEAR weight management model; ② Comprehensive coverage of the intelligent APP on the user end, and reinforcement of the regular interactive feedback and supervision mechanism of the medical team through the APP; ③ Provision of routine post-discharge care plans and follow-up programs.
干预措施: Implementation of the weight management mobile health application + Enhance the regular interaction, feedback, and supervision mechanism between medical teams and apps (Behavioral)
Experimental Group
① Implementation of the DEAR weight management model; ② Comprehensive coverage of the intelligent APP on the user end, and reinforcement of the regular interactive feedback and supervision mechanism of the medical team through the APP; ③ Provision of routine post-discharge care plans and follow-up programs.
干预措施: DEAR weight management (Behavioral)
Experimental Group
① Implementation of the DEAR weight management model; ② Comprehensive coverage of the intelligent APP on the user end, and reinforcement of the regular interactive feedback and supervision mechanism of the medical team through the APP; ③ Provision of routine post-discharge care plans and follow-up programs.
干预措施: Standardized discharge care plan and follow-up schedule (Behavioral)
Control Group
① Implementation of the DEAR weight management model; ② Participants autonomously select functional modules of the weight management APP based on individualized health needs; ③ Provision of routine post-discharge care plans and follow-up programs.
干预措施: DEAR weight management (Behavioral)
Control Group
① Implementation of the DEAR weight management model; ② Participants autonomously select functional modules of the weight management APP based on individualized health needs; ③ Provision of routine post-discharge care plans and follow-up programs.
干预措施: Standardized discharge care plan and follow-up schedule (Behavioral)
Control Group
① Implementation of the DEAR weight management model; ② Participants autonomously select functional modules of the weight management APP based on individualized health needs; ③ Provision of routine post-discharge care plans and follow-up programs.
干预措施: Implementation of the weight management mobile health application (Behavioral)
结局指标
主要结局
Body mass index (BMI)
时间窗: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Use the Inbody720 to measure height and weight and calculate BMI according to the formula "BMI (= weight (kg)/height² (m²)"
次要结局
- Waist circumference (WC)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Hip circumference (HC)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Waist-to-height ratio (WHtR)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Waist-to-hip ratio (WHR)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Body shape index (ABSI)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Body roundness index (BRI)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Visceral fat index (VAI)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Lipid accumulation index (LAP)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Triglycerides(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Cholesterol(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- High density lipoprotein (HDL)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Low density lipoprotein (LDL)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Fasting glucose(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Fasting insulin (FINS)(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Glycated hemoglobin(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Weight efficacy(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Exercise adherence(Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention)
- Complete response (CR)(One year of intervention)
- Application usage frequency(one year of intervention)
研究者
Xiaodan Li
associate professor
Peking University People's Hospital