Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Mobile Applications | — | UNRESOLVED | — |
| Weight Management | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DEAR weight management | Behavioral | — | UNRESOLVED |
| Implementation of the weight management mobile health application | Behavioral | — | UNRESOLVED |
| Implementation of the weight management mobile health application + Enhance the regular interaction, feedback, and supervision mechanism between medical teams and apps | Behavioral | — | UNRESOLVED |
| Standardized discharge care plan and follow-up schedule | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- 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.
- interventionNames
- 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
- type
- OTHER
- label
- Control Group
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available