Application-Assisted Weight Management in Endometrial Cancer Fertility Preservation

NCT06901778 | Not Yet Recruiting

• 1 other identifier: 2024PHB550-001
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Endometrial Cancer; Mobile Applications; Weight Management

Keywords

Endometrial Neoplasms; Mobile Applications; Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• 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

Study Arms (2)

Experimental Group

EXPERIMENTAL

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; 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

Control Group

OTHER

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; Behavioral: Standardized discharge care plan and follow-up schedule; Behavioral: Implementation of the weight management mobile health application

Interventions

DEAR weight management BEHAVIORAL

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.

Control Group; Experimental Group

Standardized discharge care plan and follow-up schedule BEHAVIORAL

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.

Control Group; Experimental Group

Implementation of the weight management mobile health application BEHAVIORAL

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.

Control Group

Implementation of the weight management mobile health application + Enhance the regular interaction, feedback, and supervision mechanism between medical teams and apps BEHAVIORAL

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.

Experimental Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Weight Loss

Interventions

Amyloid Precursor Protein Secretases

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Xiaodan Li

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Xiaodan Li

CONTACT

+8615010305099; lixiaodan@pkuph.edu.cn

Hui Zeng

CONTACT

+8615665269558; zenghui5678@163.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: associate professor

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: March 30, 2025
• Study Start: March 31, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-03

Locations

CN (1)