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

University of Barcelona305 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

305

Conditions

Overweight Obesity

Interventions

en_líneaBEHAVIORAL

This is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004.

Group therapyBEHAVIORAL

This is a traditional behavioral weight control program

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Overweight type II or obesity type I. BMI between 27 and 34.9 kg/m2 2. Age between 18 and 65 years old 3. Compliance with all evaluation phases. Exclusion Criteria: 1. Presence of several physical disease, i.e. diabetes, hypertension, cancer or metabolic disorders 2. Presence of several psychological problem, i.e. depression, anxiety 3. Presence of other eating disorders, i.e. anorexia nervosa, bulimia nervosa, binge eating disorders 4. Use of drugs, i.e. slimming, anovulatory or psychotropic 5. Pregnancy or planned pregnancy for the next six months 6. Following another weight control program at the time of selection.

Locations (1)

Unidad de Terapia de Conducta, University of Barcelona

Barcelona, Spain

RECRUITING

Outcomes

Primary Outcomes

Weight loss

5%-10% of weight loss respect the initial weight

Time frame: 4 months

Maintenance of weight loss 1 month follow-up

Maintenance of weight loss

Time frame: 1 month follow-up

Maintenance of weight loss 3 months follow-up

Maintenance of weight loss

Time frame: 3 months follow-up

Maintenance of weight loss 6 months follow-up

Maintenance of weight loss

Time frame: 6 months follow-up

Maintenance of weight loss 12 months follow-up

Maintenance of weight loss

Time frame: 12 months follow-up

Secondary Outcomes

Adherence

80% of completed website activities and 80% of self-records

Time frame: 4 months

Drop out

Percentage of participants who finish the treatment

Time frame: 4 months

Quality of life test measures

Questionnaire of Quality of Life provided by the LEARN program

Time frame: 4 months

Central Contacts

Carmina Saldaña, PhD

CONTACT

+3493312125 csaldana@ub.edu

Data from ClinicalTrials.gov

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