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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: digital behavioral interventionExperimental treatment 1 intervention
Group B: Regular Education GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Weight change

Time frame
From enrollment to the end of treatment at 8 weeks
2

Number of oocytes retrieved

Time frame
up to 16weeks
3

Number of embryos available for transfer

Time frame
up to 17 weeks

Secondary outcomes

1

Percentage of weight loss

Time frame
From enrollment to the end of treatment at 8 weeks
2

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.

Time frame
From enrollment to the end of treatment at 8 weeks
3

live birth rate

Time frame
2 years
4

Pregnancy rate

Time frame
up to 1 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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