En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity
- Conditions
- OverweightObesity
- Interventions
- Behavioral: en_líneaBehavioral: Group therapy
- Registration Number
- NCT04127201
- Lead Sponsor
- University of Barcelona
- Brief Summary
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
- Detailed Description
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/m2) or obesity type I (30-34.9 kg/m2) 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 305
- Overweight type II or obesity type I. BMI between 27 and 34.9 kg/m2
- Age between 18 and 65 years old
- Compliance with all evaluation phases.
- Presence of several physical disease, i.e. diabetes, hypertension, cancer or metabolic disorders
- Presence of several psychological problem, i.e. depression, anxiety
- Presence of other eating disorders, i.e. anorexia nervosa, bulimia nervosa, binge eating disorders
- Use of drugs, i.e. slimming, anovulatory or psychotropic
- Pregnancy or planned pregnancy for the next six months
- Following another weight control program at the time of selection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Online intervention, en_línea en_línea Participants will be provided with a username and a password to acess to a website. en_línea program is an online adaptation of the LEARN program. The five treatment areas are: Lifestyle, Exercise, Attitudes, Relationships and Nutrition. We have designed and developed a website (www.programaenlinea.org) with 17 weekly treatment sessions and an exclusive mobile application for self-recording. Standard group therapy Group therapy Participants in this arm will received a 10 sessions of standard primary care group therapy. Sessions 1 and 2 will be weekly and sessions from 3 to 10 will be biweekly. Sessions, between 8 and 10 participants, will be conducted by a specialized psychologist and they will last 90 minutes. Treatment areas will be the same as en_línea, beginning with nutrition and exercise and a progressive incorporation of the other topics. Material to work at home and self-recording will be provided in paper.
- Primary Outcome Measures
Name Time Method Maintenance of weight loss 6 months follow-up 6 months follow-up Maintenance of weight loss
Weight loss 4 months 5%-10% of weight loss respect the initial weight
Maintenance of weight loss 1 month follow-up 1 month follow-up Maintenance of weight loss
Maintenance of weight loss 3 months follow-up 3 months follow-up Maintenance of weight loss
Maintenance of weight loss 12 months follow-up 12 months follow-up Maintenance of weight loss
- Secondary Outcome Measures
Name Time Method Adherence 4 months 80% of completed website activities and 80% of self-records
Drop out 4 months Percentage of participants who finish the treatment
Quality of life test measures 4 months Questionnaire of Quality of Life provided by the LEARN program
Trial Locations
- Locations (1)
Unidad de Terapia de Conducta, University of Barcelona
🇪🇸Barcelona, Spain