Application-Assisted Weight Management in Endometrial Cancer Fertility Preservation

Not Applicable

Not yet recruiting

• Conditions: Endometrial Cancer; Mobile Applications; Weight Management

• Registration Number: NCT06901778
• Lead Sponsor: Peking University People's Hospital

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.

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 Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-24
• Study First Posted: 2025-03-30
• Study Start: 2025-03-31
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-03-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Body mass index (BMI)	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)"

Secondary Outcome Measures

Name	Time	Method
Waist circumference (WC)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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
Hip circumference (HC)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	Measured with the subject's body upright, taking the circumference of the body at the horizontal position of the uppermost point of the hip
Waist-to-height ratio (WHtR)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	Calculate WHtR according to the formula "WHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm)"
Waist-to-hip ratio (WHR)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	Calculate WHR according to the formula "WHR=waist circumference (cm)/hip circumference (cm)"
Body shape index (ABSI)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	Calculate ABSI according to the formula "ABSI= (waist)/(\[BMI\]\^2/3×height\^1/2)"
Body roundness index (BRI)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	Calculate BRI according to the formula "BRI= waist/BMI"
Visceral fat index (VAI)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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"
Lipid accumulation index (LAP)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	Calculate LAP according to the formula "LAP= = (waist circumference - 58) × TG level"
Triglycerides	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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
Cholesterol	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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
High density lipoprotein (HDL)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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
Low density lipoprotein (LDL)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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
Fasting glucose	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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
Fasting insulin (FINS)	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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
Glycated hemoglobin	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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
Weight efficacy	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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
Exercise adherence	Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention	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
Complete response (CR)	One year of intervention	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)
Application usage frequency	one year of intervention	The backend retrieves user application usage days data within a year, defining application usage frequency by the number of application usage days.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, China