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

University of Barcelona

Status: Unknown

Conditions: Overweight; Obesity

Treatments: Behavioral: Group therapy; Behavioral: en_línea

Study type: Interventional

Funder types: Other

Identifiers

NCT04127201

IRB00003099

Details and patient eligibility

About

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

Full 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.

Enrollment: 305 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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305 participants in 3 patient groups

Online intervention, en_línea

Experimental group

Description:

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.

Treatment:

Behavioral: en_línea

Standard group therapy

Active Comparator group

Description:

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.

Treatment:

Behavioral: Group therapy

Control group

No Intervention group

Description:

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.