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Endometrial CancerNCT06901778

Application-Assisted Weight Management in Endometrial Cancer Fertility Preservation

A study testing DEAR weight management, Standardized discharge care plan and follow-up schedule and Implementation of the weight management mobile health application in people with Endometrial Cancer and Mobile Applications, run by Peking University People's Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years, women only
What is being tested?
DEAR weight management, Standardized discharge care plan and follow-up schedule and Implementation of the weight management mobile health application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteChina
Study dates
31 Mar 2025to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Peking University People's Hospital

    Beijing, 100044

    Xiaodan Li, +8615010305099, lixiaodan@pkuph.edu.cn

    Hui Zeng, +8615665269558, zenghui5678@163.com

Other trials in China

About this study

Official title: 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.

Read the 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).

Being tested
DEAR weight management, Standardized discharge care plan and follow-up schedule, Implementation of the weight management mobile health application, Implementation of the weight management mobile health application + Enhance the regular interaction, feedback, and supervision mechanism between medical teams and apps
Keywords
Endometrial Neoplasms, Mobile Applications, Weight Loss
Medical subject headings
Endometrial Neoplasms, Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DEAR weight managementBehavioural

    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.

  • Standardized discharge care plan and follow-up scheduleBehavioural

    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.

  • Implementation of the weight management mobile health applicationBehavioural

    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.

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

    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.

Study groups in NCT06901778
Study groupRoleWhat they receive
Experimental GroupExperimental① 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.
Receives: 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 GroupOther① 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.
Receives: Behavioral: DEAR weight management; Behavioral: Standardized discharge care plan and follow-up schedule; Behavioral: Implementation of the weight management mobile health application

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)"

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

Secondary outcomes (19)
  1. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  2. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  3. Waist-to-height ratio (WHtR)

    Calculate WHtR according to the formula "WHtR= waist circumference (cm)/height (cm)= waist circumference (cm)/height (cm)"

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  4. Waist-to-hip ratio (WHR)

    Calculate WHR according to the formula "WHR=waist circumference (cm)/hip circumference (cm)"

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  5. Body shape index (ABSI)

    Calculate ABSI according to the formula "ABSI= (waist)/([BMI]^2/3×height^1/2)"

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  6. Body roundness index (BRI)

    Calculate BRI according to the formula "BRI= waist/BMI"

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  7. 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"

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  8. Lipid accumulation index (LAP)

    Calculate LAP according to the formula "LAP= = (waist circumference - 58) × TG level"

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  9. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  10. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  11. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  12. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  13. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  14. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  15. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  16. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  17. 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

    Measured: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention

  18. 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)

    Measured: One year of intervention

  19. 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.

    Measured: one year of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Mar 2025
  2. Study start31 Mar 2025 (estimated)
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06901778
Sponsor's protocol ID
2024PHB550-001
Status last verified
Mar 2025
First submitted
24 Mar 2025
Last updated
3 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing DEAR weight management, Standardized discharge care plan and follow-up schedule and Implementation of the weight management mobile health application in people with Endometrial Cancer and Mobile Applications, run by Peking University People's Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaodan Li (+8615010305099, lixiaodan@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Body mass index (BMI) (time frame: Baseline / Month 3 of intervention / Month 6 of intervention / Month 9 of intervention / Month 12 of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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