Efficacy of an Internet-based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Spontaneous clinical pregnancy rate
研究概览
简要总结
Obesity and overweight are among the problems that produce infertility. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women.
Aim: to evaluate the effectiveness of an online program to promote a healthy lifestyle among women who are overweight or obese who also have a diagnosis of infertility and are on the waiting list for in vitro fertilisation treatment
详细描述
Weight management problems (being obese or overweight) are among the problems that produce infertility. The combination of diet and exercise to achieve weight loss are currently considered an effective intervention for the improvement of reproductive parameters in overweight or obese infertile women.
Aim: to evaluate the effectiveness of a 3-month internet-based program focusing on the promotion of healthy lifestyles (especially weight loss and healthy eating and physical exercise habits) in women who also have a diagnosis of infertility and are on the waiting list for IVF treatment.
Design: randomised controlled trial Setting: Hospital La Plana (Villarreal)
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women of childbearing age
- •overweight (BMI > 25 kg/m2) or obese (BMI > 30 kg/m2)
- •diagnosed with primary infertility -access to the internet-
排除标准
- •over 40 years
- •morbid or extreme obesity (BMI > 40 kg/m2)
- •bilateral obstruction of the fallopian tubes
- •endometriosis
- •women whose partner has a severe male factor (oligoasthenoteratozoospermia).
结局指标
主要结局
Spontaneous clinical pregnancy rate
时间窗: 12 months
The primary outcome will be the spontaneous clinical pregnancy rate (pregnancy with ultrasound visualisation of the gestational sac at week 7 of pregnancy) and evolution (pregnancy with ultrasound visualisation of the gestational sac and a heartbeat after 20 weeks of gestation).
次要结局
- Body mass index (BMI)(12 months)
- Physical activity level(12 months)
- Abdominal perimeter(12 months)
- Mediterranean Diet Adherence(12 months)
研究者
Juan F. Lisón Párraga, Dr
Head of Medicine
Cardenal Herrera University