Application-Assisted Weight Management in Endometrial Cancer Fertility Preservation

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endometrial Cancer; Mobile Applications; Weight Management
• Intervention / Treatment: Behavioral: DEAR weight management; Behavioral: Standardized discharge care plan and follow-up schedule; Behavioral: Implementation of the weight management mobile health application + Enhance the regular interaction, feedback, and supervision mechanism between medical teams and apps; Behavioral: Implementation of the weight management mobile health application

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).

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaodan Li; Phone Number: +8615010305099; Email: lixiaodan@pkuph.edu.cn
• Study Contact Backup: Name: Hui Zeng; Phone Number: +8615665269558; Email: zenghui5678@163.com

Study Locations

• China
  • Beijing, China, 100044
    • Peking University People's Hospital
    • Contact: Xiaodan Li; Phone Number: +8615010305099; Email: lixiaodan@pkuph.edu.cn
    • Contact: Hui Zeng; Phone Number: +8615665269558; Email: zenghui5678@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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 involves using peer education methods to provide health education for patients, build confidence, and alleviate anxiety; R (Refresh) refers to rejuvenation, which involves correcting unhealthy dietary and exercise habits and establishing good lifestyle practices.; 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' questions, encourage peer-to-peer experience sharing, and conduct regular telephone follow-ups and questionnaire surveys after discharge.; 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 medical team. All members hold a bachelor's degree or above and possess rich clinical weight management experience. Through the app, they provide users with scientific and rigorous supervision and guidance. During weight loss, users can obtain accurate, professional answers and personalized adjustment advice in real-time via the app's question-asking column if they encounter any problems.
Other: 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.	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 involves using peer education methods to provide health education for patients, build confidence, and alleviate anxiety; R (Refresh) refers to rejuvenation, which involves correcting unhealthy dietary and exercise habits and establishing good lifestyle practices.; 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' questions, encourage peer-to-peer experience sharing, and conduct regular telephone follow-ups and questionnaire surveys after discharge.; 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., BMI calculation and personal weight change curves). The app interface also provides professional guidance on diet and exercise, such as food calorie information, customized nutritional meal plans, and specialized exercise programs with training courses. By offering educational articles and instructional videos, the app aims to promote correct weight management concepts, disseminate scientific health knowledge, and enhance self-efficacy in weight loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index (BMI)	Use the Inbody720 to measure height and weight and calculate BMI according to the formula "BMI (= weight (kg)/height² (m²)"	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference (WC)	Physiological parameter measured with the subject's body upright, abdomen relaxed, both arms hanging down naturally, feet together, and the tape measure placed around the waist; the height was adjusted to the horizontal plane passing through the midpoint of the line between the lower edge of the rib arch and the iliac crest in the mid-axillary line	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Hip circumference (HC)	Measured with the subject's body upright, taking the circumference of the body at the horizontal position of the uppermost point of the hip	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Waist-to-height ratio (WHtR)	Calculate WHtR according to the formula "WHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm)"	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Waist-to-hip ratio (WHR)	Calculate WHR according to the formula "WHR=waist circumference (cm)/hip circumference (cm)"	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Body shape index (ABSI)	Calculate ABSI according to the formula "ABSI= (waist)/([BMI]^2/3×height^1/2)"	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Body roundness index (BRI)	Calculate BRI according to the formula "BRI= waist/BMI"	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Visceral fat index (VAI)	Calculate VAI according to the formula "VAI= waist/(36.58 + 1.89 × BMI) × triglyceride (TG) level/0.81 × 1.52/high density lipoprotein (HDL) level"	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Lipid accumulation index (LAP)	Calculate LAP according to the formula "LAP= = (waist circumference - 58) × TG level"	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Triglycerides	About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Cholesterol	About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
High density lipoprotein (HDL)	About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Low density lipoprotein (LDL)	About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Fasting glucose	About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Fasting insulin (FINS)	About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Glycated hemoglobin	About 5 ml of venous blood was drawn from the study subjects in the fasting state in the morning and sent to the Laboratory Department of the People's Hospital of Peking University, where it was measured by Beckman AU5800 biochemical analyzer	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Complete response (CR)	Complete remission indicated by complete endometrial regression and interstitial metaplasia-like changes on histopathology after treatment (without any endometrial atypical hyperplasia or endometrioid adenocarcinoma lesions, as clarified by pathologists)	One year of intervention
Application usage frequency	The backend retrieves user application usage days data within a year, defining application usage frequency by the number of application usage days.	one year of intervention
Weight efficacy	The Weight Efficacy Lifestyle Questionnaire-Short Form (WEL-SF) was utilized to assess Weight Efficacy. This validated instrument comprises 8 items, scored on a scale of 0 to 80, with higher scores indicating greater self-efficacy in weight management	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention
Exercise adherence	The Chinese-translated version of the Exercise Adherence Rating Scale (EARS) was employed to evaluate Exercise Adherence. The EARS consists of 16 items, scored from 0 to 64, with higher scores reflecting stronger exercise adherence. Items 1, 3, 5, 9, 13, 14, and 16 are reverse-scored to ensure psychometric accuracy	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Study Chair: Xiaodan Li, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: March 24, 2025
• First Submitted That Met QC Criteria: March 24, 2025
• First Posted (Actual): March 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 3, 2025
• Last Update Submitted That Met QC Criteria: March 31, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Weight Loss; Mobile Applications; Endometrial Neoplasms
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Uterine Neoplasms; Body Weight; Endometrial Neoplasms
• Other Study ID Numbers: 2024PHB550-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No