NCT07045272Not yet recruiting
Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients
Study on the Construction and Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients Prior to Assisted Reproductive Technology(ART)Treatment
Source: ClinicalTrials.gov · Last updated 1 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study applied digital technology to a comprehensive lifestyle intervention strategy to design a digital behavioural intervention programme suitable for weight reduction in overweight obese infertile patients in China, and assessed its intervention effect through a randomised controlled trial.The main questions it aims to answer are: 1\) Design and implement a digital behavioural weight loss intervention programme; 2) Evaluate the impact of digital behavioural interventions on weight loss outcomes and health outcomes. Participants will be randomly assigned to a control group and an intervention group. The control group will receive only routine health education and the intervention group will receive an 8-week digital behavioural intervention. At the end of the intervention, the follow-up period will be one year for reproductive outcomes.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- First submitted
- 9 Jun 2025
- Start date
- 10 Jul 2025
- Primary completion date
- 20 Aug 2026
- Lead sponsor
- Anhui Medical University
- Diseases
- Obesity
- NCT number
- NCT07045272
What you commit to
- Study type: Interventional
- Planned participants: 90
- From 10 Jul 2025 to the primary completion date, 20 Aug 2026
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or prior participation in other clinical trials within the past 3 months;
- Previous weight-loss interventions, including pharmacological therapy (e.g., orlistat, liraglutide) or bariatric surgery.
Other illness
- History of major systemic diseases (e.g., cardiovascular disorders, chronic respiratory diseases) or psychiatric disorders (e.g., schizophrenia, major depressive disorder);
- Medical contraindications to physical exercise (e.g., severe osteoarthritis, uncontrolled arrhythmias);
Who the study is looking for
- Fulfilling the World Health Organization diagnostic criteria for infertility, defined as failure to achieve or sustain a clinical pregnancy after ≥1 year of regular unprotected sexual intercourse among couples of reproductive age;
- patients aged 20-40 years seeking assisted reproductive technology (ART) treatment;
- Body mass index (BMI) \>=24 kg/m²;
- Willingness to undergo randomization;
- Absence of significant comorbidities (e.g., uncontrolled hypertension, diabetes mellitus, malignancies);
- Commitment to participate in and complete the intervention protocol.
Age in the registry: 20 years to 40 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.