En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity: Study Protocol for a Randomized Controlled Trial

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Behavioral: en_línea
* Behavioral: Group therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Online intervention, en_línea<br>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. | Behavioral: en_línea<br>* This is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004.<br>* Other names: Web-based weight control program;|
| Active Comparator: Standard group therapy<br>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. | Behavioral: Group therapy<br>* This is a traditional behavioral weight control program<br>|
| No Intervention: Control group<br>Participants in the control group only will receive a biweekly newsletter by email without feedback. They will be provided with material and instructions to self-record their daily meals and exercise. The newsletter only will content basic information about nutrition and exercise. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | 5%-10% of weight loss respect the initial weight | 4 months | 
| Maintenance of weight loss 1 month follow-up | Maintenance of weight loss | 1 month follow-up | 
| Maintenance of weight loss 3 months follow-up | Maintenance of weight loss | 3 months follow-up | 
| Maintenance of weight loss 6 months follow-up | Maintenance of weight loss | 6 months follow-up | 
| Maintenance of weight loss 12 months follow-up | Maintenance of weight loss | 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | 80% of completed website activities and 80% of self-records | 4 months | 
| Drop out | Percentage of participants who finish the treatment | 4 months | 
| Quality of life test measures | Questionnaire of Quality of Life provided by the LEARN program | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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online therapy, weight loss control program, Internet