Clinical trial

Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients

Opening soon · Not applicable · 0 countries · Registry ID NCT07045272

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 40 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight or Obesity

Full registry criteria

Inclusion Criteria: 1. 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; 2. patients aged 20-40 years seeking assisted reproductive technology (ART) treatment; 3. Body mass index (BMI) \>=24 kg/m²; 4. Willingness to undergo randomization; 5. Absence of significant comorbidities (e.g., uncontrolled hypertension, diabetes mellitus, malignancies); 6. Commitment to participate in and complete the intervention protocol. Exclusion Criteria: 1. History of major systemic diseases (e.g., cardiovascular disorders, chronic respiratory diseases) or psychiatric disorders (e.g., schizophrenia, major depressive disorder); 2. Current or prior participation in other clinical trials within the past 3 months; 3. Medical contraindications to physical exercise (e.g., severe osteoarthritis, uncontrolled arrhythmias); 4. Previous weight-loss interventions, including pharmacological therapy (e.g., orlistat, liraglutide) or bariatric surgery.

Treatments and study arms

Experimental

Behavioral

The 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.

Primary outcomes

Weight changeFrom enrollment to the end of treatment at 8 weeks
Number of oocytes retrievedup to 16weeks
Number of embryos available for transferup to 17 weeks

Study locations

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No public site location was included in this record. Check the original registry for updates.