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

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

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

Study Overview

• Status: Unknown
• Conditions: Obesity; Overweight
• Intervention / Treatment: Behavioral: en_línea; Behavioral: Group therapy

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 Type: Interventional
• Enrollment (Anticipated): 305
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08035
    • Recruiting
    • Unidad de Terapia de Conducta, University of Barcelona
    • Contact: Carmina Saldaña, PhD; Phone Number: +34933125125; Email: csaldana@ub.edu
    • Contact: Carmen Varela, MsC; Phone Number: +34933125023; Email: carmenvarela@ub.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Online intervention, en_línea; 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; This is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004.; Other Names: Web-based weight control program
Active Comparator: Standard group therapy; 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; This is a traditional behavioral weight control program
No Intervention: Control group; 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?

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

Collaborators and Investigators

• Sponsor: University of Barcelona

Publications and helpful links

General Publications

• Varela C, Saldana C. En_Linea. An online treatment to change lifestyle in overweight and obesity: study protocol for a randomized controlled trial. BMC Public Health. 2019 Nov 21;19(1):1552. doi: 10.1186/s12889-019-7928-1.

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2016
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 11, 2019
• First Submitted That Met QC Criteria: October 11, 2019
• First Posted (Actual): October 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 11, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Internet; "online therapy"; "weight loss control program"
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Overweight
• Other Study ID Numbers: IRB00003099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Research team have to meet and make a decision about this field

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No