En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity
1 other identifier
interventional
305
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 12, 2016
CompletedFirst Submitted
Initial submission to the registry
October 11, 2019
CompletedFirst Posted
Study publicly available on registry
October 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedOctober 15, 2019
October 1, 2019
4 years
October 11, 2019
October 11, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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 Outcomes (3)
Adherence
4 months
Drop out
4 months
Quality of life test measures
4 months
Study Arms (3)
Online intervention, en_línea
EXPERIMENTALParticipants 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.
Standard group therapy
ACTIVE COMPARATORParticipants 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.
Control group
NO INTERVENTIONParticipants 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.
Interventions
This is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004.
This is a traditional behavioral weight control program
Eligibility Criteria
You may qualify if:
- Overweight type II or obesity type I. BMI between 27 and 34.9 kg/m2
- Age between 18 and 65 years old
- Compliance with all evaluation phases.
You may not qualify if:
- Presence of several physical disease, i.e. diabetes, hypertension, cancer or metabolic disorders
- Presence of several psychological problem, i.e. depression, anxiety
- Presence of other eating disorders, i.e. anorexia nervosa, bulimia nervosa, binge eating disorders
- Use of drugs, i.e. slimming, anovulatory or psychotropic
- Pregnancy or planned pregnancy for the next six months
- Following another weight control program at the time of selection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unidad de Terapia de Conducta, University of Barcelona
Barcelona, 08035, Spain
Related Publications (1)
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.
PMID: 31752815DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
October 11, 2019
First Posted
October 15, 2019
Study Start
December 12, 2016
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
October 15, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share
Research team have to meet and make a decision about this field