Application-Assisted Weight Management in Endometrial Cancer Fertility Preservation

Official title

Adaptive Behavioral Intervention Application for Weight Control in Obese/Overweight Endometrial Cancer Patients in Fertility Preservation:A Randomized Clinical Trial

Overview

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.

Detailed description

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).

Interventions

• Behavioral DEAR weight management
  In the DEAR weight management model: D (Diet) refers to dietary management, primarily based on a calorie-restricted balanced diet; E (Exercise) refers to exercise management, guided by the 10th edition of the ACSM Exercise Testing and Prescription Guidelines and the 2017 National Fitness Guidelines. Exercise prescriptions are tailored to the patient's daily activity levels (light, moderate, and vigorous) to match the corresponding intensity levels; A (Accompany) refers to peer education, which
• Behavioral Standardized discharge care plan and follow-up schedule
  Standardized discharge care plan and follow-up schedule providing patients and their families with professional and feasible pre-discharge education on disease-related knowledge, dietary and exercise recommendations, daily living advice, and psychological support to help patients establish healthy behaviors. Patients are provided with printed health education materials and a handbook on health and disease knowledge. A WeChat communication group is established to promptly answer patients' questio
• Behavioral Implementation of the weight management mobile health application
  Patients undergoing weight management are instructed to download the app from the app store (compatible with both iOS and Android platforms). Users in the control group can independently register and log in using their mobile phone numbers to access and use the app. The app will create an electronic health record for weight management for each user. Users can input their weight-related information, and the app features a data analysis function that displays weight trends through charts (e.g., BM
• Behavioral Implementation of the weight management mobile health application + Enhance the regular interaction, feedback, and supervision mechanism between medical teams and apps
  Based on the intelligent app's comprehensive coverage on the user side and integrating the ABI concept, the app dynamically adjusts intervention strategies. This is achieved by real-time collection and analysis of user behavior data, providing users with all around and personalized weight management support across diet, exercise, psychological support, etc., thereby enhancing the effectiveness and sustainability of interventions. The research team has formed a professional and experienced medica

Primary outcome measures

• Body mass index (BMI) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]

Secondary outcome measures (12)

• Waist circumference (WC) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• Hip circumference (HC) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• Waist-to-height ratio (WHtR) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• Waist-to-hip ratio (WHR) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• Body shape index (ABSI) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• Body roundness index (BRI) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• Visceral fat index (VAI) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• Lipid accumulation index (LAP) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• Triglycerides [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• Cholesterol [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• High density lipoprotein (HDL) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]
• Low density lipoprotein (LDL) [Time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Peking University People's Hospital — Beijing

Identifiers

NCT: NCT06901778 · 2024PHB550-001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗