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NCT Number: NCT07045272

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

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.

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Key information

Conditions

Overweight or Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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;
  • Absence of significant comorbidities (e.g., uncontrolled hypertension, diabetes mellitus, malignancies);
  • Commitment to participate in and complete the intervention protocol.

Exclusion criteria

  • 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.

Treatment and study plan

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

  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

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

    using the InBody instrument, which relies on the principle of bioelectrical impedance analysis (BIA) to rapidly assess body composition without radiation exposure.

  3. live birth rate

    Time frame: 2 years

  4. Pregnancy rate

    Time frame: up to 1 year

Sponsors and collaborators

Lead sponsor

Anhui Medical University

Other

Registry information

Official study title

Study on the Construction and Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients Prior to Assisted Reproductive Technology(ART)Treatment

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 1, 2025
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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