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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Experimental
BehavioralThe intervention team provides lifestyle guidance to the subjects according to the behavioural intervention programme, and the subjects record information on diet, exercise and weight on the platform on a daily basis. Subjects are required to learn relevant health education knowledge on the platform by themselves, and they can also exchange experience in the group and receive motivational counselling from the instructors.
Treatment groups
Trial outcomes
Primary outcomes
Weight change
Number of oocytes retrieved
Number of embryos available for transfer
Secondary outcomes
Percentage of weight loss
Body fat content and distribution
using the InBody instrument, which relies on the principle of bioelectrical impedance analysis (BIA) to rapidly assess body composition without radiation exposure.
live birth rate
Pregnancy rate
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: