En_Línea. An online treatment to change lifestyle in overweight and obesity: study protocol for a randomized controlled trial

BACKGROUND: Obesity has become a major public health problem. Innovative treatments are necessary. Internet and new technologies have been reported effective results in weight control programs, especially those with personalized feedback. This paper presents the protocol for a randomized controlled trial to test the effectiveness of an online weight control program, called en_línea, comparing with a standard group therapy and a control group. METHODS: This is a randomized controlled trial with three intervention arms: en_línea, standard group therapy and control group. To perform this study, 305 adults (18–65 years) with overweight type II (27–29.9 kg/m(2)) or obesity type I (30–34.9 kg/m(2)) will be invited to participate. Interventions will last 17 weeks with follow-ups 1, 3, 6 and 12 months after the post-treatment appointment. The primary outcome will be post-treatment weight loss and the maintenance during the follow-ups. Secondary outcomes will be adherence rates, drop outs and quality of life. Participants will be assessed before randomization and they will be sign an inform consent. DISCUSSION: The future challenge is to design innovative obesity treatments. Internet could be a useful tool to improve traditional weight control programs. This new intervention format is appropriate for patients who prefer not to share their intimate problems with a group, and for the new generations who feel comfortable using new technologies. Besides, Internet allows reaching a large amount of people at the same time, even if they live far away. TRIAL REGISTRATION: ClinicalTrials.gov NCT04127201. Retrospectively registered 15th October 2019.