Study on the Construction and Effectiveness of a Digital Behavioral Intervention Program for Overweight and Obese Patients Prior to Assisted Reproductive Technology(ART)Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 主要终点
- Weight change
研究概览
简要总结
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:
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Regular Education Group
Physicians provided only their standard verbal counseling during clinic visits, without any additional interventions.
digital behavioral intervention
A comprehensive intervention program that combines digital technologies，Including interventions for diet, exercise, mood, sleep, etc.
干预措施: Experimental (Behavioral)
结局指标
主要结局
Weight change
时间窗: From enrollment to the end of treatment at 8 weeks
Number of oocytes retrieved
时间窗: up to 16weeks
Number of embryos available for transfer
时间窗: up to 17 weeks
次要结局
- live birth rate(2 years)
- Pregnancy rate(up to 1 year)
- Percentage of weight loss(From enrollment to the end of treatment at 8 weeks)
- Body fat content and distribution(From enrollment to the end of treatment at 8 weeks)
研究者
Wang Danni
Associate Professor
Anhui Medical University