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

Not Applicable

• Conditions: Overweight; Obesity

• 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.

Study Timeline

• Study Start: 2016-12-12
• Status Verified: 2019-10
• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Last Update Submitted: 2019-10-11
• Study First Posted: 2019-10-15
• Last Update Posted: 2019-10-15
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 305

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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