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

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Experimental
  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.

Первичные конечные точки

• Weight change [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Number of oocytes retrieved [Срок оценки: up to 16weeks]
• Number of embryos available for transfer [Срок оценки: up to 17 weeks]

Вторичные конечные точки (4)

• Percentage of weight loss [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Body fat content and distribution [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• live birth rate [Срок оценки: 2 years]
• Pregnancy rate [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07045272 · WDanni

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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