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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04127201
• Other study ID #: IRB00003099
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: University of Barcelona
• Contact: Carmina Saldaña, PhD
• Phone: +3493312125
• Email: csaldana[@]ub.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 305
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Behavioral:
• en_línea
This is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004.
• Group therapy
This is a traditional behavioral weight control program

Locations

Country	Name	City	State
Spain	Unidad de Terapia de Conducta, University of Barcelona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
University of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight loss	5%-10% of weight loss respect the initial weight	4 months
Primary	Maintenance of weight loss 1 month follow-up	Maintenance of weight loss	1 month follow-up
Primary	Maintenance of weight loss 3 months follow-up	Maintenance of weight loss	3 months follow-up
Primary	Maintenance of weight loss 6 months follow-up	Maintenance of weight loss	6 months follow-up
Primary	Maintenance of weight loss 12 months follow-up	Maintenance of weight loss	12 months follow-up
Secondary	Adherence	80% of completed website activities and 80% of self-records	4 months
Secondary	Drop out	Percentage of participants who finish the treatment	4 months
Secondary	Quality of life test measures	Questionnaire of Quality of Life provided by the LEARN program	4 months