Efficacy of an Internet-Based Intervention to Promote a Healthy Lifestyle on the Reproductive Parameters of Overweight and Obese Women: Study Protocol for a Randomised Controlled Trial.

Background: Infertility is estimated to affect 15% of couples of reproductive age. Weight management problems (being obese or overweight) are among the problems that produce infertility, both in women seeking spontaneous pregnancy and in those undergoing assisted reproduction techniques. Over the last few decades, the prevalence of obesity has increased alarmingly in our society and is now considered one of the most important public health problems. 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. In other population groups, it has been shown that Internet-based interventions are just as effective as traditional ones, and these cover a larger population with a good cost-benefit ratio. However, to the best of our knowledge, no studies so far have analysed any specific online interventions for this group of infertile women. Thus, the objective of this project will be 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. Methods: This will be a randomised controlled clinical trial conducted in 94 women which will compare a self-administered Internet-based intervention promoting a healthy lifestyle in terms of diet and exercise (n = 47) to a control group that will receive standard medical care. The online program will comprise nine modules, will last for 3 months, and will be monitored every 3 months after the intervention until the final follow-up at 12 months. The main outcome will be the spontaneous pregnancy rate. Secondary outcomes will include changes in body composition, dietary and physical exercise habits, glycaemic profiles, lipid profiles, hormonal profiles, and patient quality of life related to their fertility problems. The data analysis will be done on an intention-to-treat basis. Discussion: The aim of this study is to increase our knowledge of the effectiveness of online interventions specifically adapted to infertile women who are overweight or obese in the promotion of healthy lifestyles.