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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-40
SponsorAnhui Medical University

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

Treatment groups

90 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators