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

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ClinicalTrials.gov Identifier: NCT04127201
Recruitment Status : Recruiting
First Posted : October 15, 2019
Last Update Posted : October 15, 2019
Sponsor:
Information provided by (Responsible Party):
Carmina Saldaña, University of Barcelona

Study Description
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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

Condition or disease Intervention/treatment Phase
Overweight Obesity Behavioral: en_línea Behavioral: Group therapy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity: Study Protocol for a Randomized Controlled Trial
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arms and Interventions
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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 Name: 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.


Outcome Measures
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Primary Outcome Measures :
  1. Weight loss [ Time Frame: 4 months ]
    5%-10% of weight loss respect the initial weight

  2. Maintenance of weight loss 1 month follow-up [ Time Frame: 1 month follow-up ]
    Maintenance of weight loss

  3. Maintenance of weight loss 3 months follow-up [ Time Frame: 3 months follow-up ]
    Maintenance of weight loss

  4. Maintenance of weight loss 6 months follow-up [ Time Frame: 6 months follow-up ]
    Maintenance of weight loss

  5. Maintenance of weight loss 12 months follow-up [ Time Frame: 12 months follow-up ]
    Maintenance of weight loss


Secondary Outcome Measures :
  1. Adherence [ Time Frame: 4 months ]
    80% of completed website activities and 80% of self-records

  2. Drop out [ Time Frame: 4 months ]
    Percentage of participants who finish the treatment

  3. Quality of life test measures [ Time Frame: 4 months ]
    Questionnaire of Quality of Life provided by the LEARN program


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04127201


Contacts
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Contact: Carmina Saldaña, PhD +3493312125 csaldana@ub.edu

Locations
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Spain
Unidad de Terapia de Conducta, University of Barcelona Recruiting
Barcelona, Spain, 08035
Contact: Carmina Saldaña, PhD    +34933125125    csaldana@ub.edu   
Contact: Carmen Varela, MsC    +34933125023    carmenvarela@ub.edu   
Sponsors and Collaborators
University of Barcelona
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Carmina Saldaña, PhD, University of Barcelona
ClinicalTrials.gov Identifier: NCT04127201    
Other Study ID Numbers: IRB00003099
First Posted: October 15, 2019    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Research team have to meet and make a decision about this field

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carmina Saldaña, University of Barcelona:
"online therapy"
"weight loss control program"
Internet
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight