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

Anhui Medical University

Status: Not yet enrolling

Conditions: Overweight or Obesity

Treatments: Behavioral: Experimental

Study type: Interventional

Funder types: Other

Identifiers

NCT07045272

WDanni

Details and patient eligibility

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

digital behavioral intervention

Experimental group

Description:

A comprehensive intervention program that combines digital technologies，Including interventions for diet, exercise, mood, sleep, etc.

Treatment:

Behavioral: Experimental

Regular Education Group

No Intervention group

Description:

Physicians provided only their standard verbal counseling during clinic visits, without any additional interventions.