About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
History of major systemic diseases (e.g., cardiovascular disorders, chronic respiratory diseases) or psychiatric disorders (e.g., schizophrenia, major depressive disorder);
Current or prior participation in other clinical trials within the past 3 months;
Medical contraindications to physical exercise (e.g., severe osteoarthritis, uncontrolled arrhythmias);
Previous weight-loss interventions, including pharmacological therapy (e.g., orlistat, liraglutide) or bariatric surgery.
Trial design
Treatments tested in this trial
- Experimental