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

Primary Purpose

Overweight, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
en_línea
Group therapy
Sponsored by
University of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight focused on measuring "online therapy", "weight loss control program", Internet

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Unidad de Terapia de Conducta, University of BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Online intervention, en_línea

Standard group therapy

Control group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Weight loss
5%-10% of weight loss respect the initial weight
Maintenance of weight loss 1 month follow-up
Maintenance of weight loss
Maintenance of weight loss 3 months follow-up
Maintenance of weight loss
Maintenance of weight loss 6 months follow-up
Maintenance of weight loss
Maintenance of weight loss 12 months follow-up
Maintenance of weight loss

Secondary Outcome Measures

Adherence
80% of completed website activities and 80% of self-records
Drop out
Percentage of participants who finish the treatment
Quality of life test measures
Questionnaire of Quality of Life provided by the LEARN program

Full Information

First Posted
October 11, 2019
Last Updated
October 11, 2019
Sponsor
University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT04127201
Brief Title
En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity
Official Title
En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity: Study Protocol for a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
Keywords
"online therapy", "weight loss control program", Internet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
305 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online intervention, en_línea
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard group therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
en_línea
Other Intervention Name(s)
Web-based weight control program
Intervention Description
This is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004.
Intervention Type
Behavioral
Intervention Name(s)
Group therapy
Intervention Description
This is a traditional behavioral weight control program
Primary Outcome Measure Information:
Title
Weight loss
Description
5%-10% of weight loss respect the initial weight
Time Frame
4 months
Title
Maintenance of weight loss 1 month follow-up
Description
Maintenance of weight loss
Time Frame
1 month follow-up
Title
Maintenance of weight loss 3 months follow-up
Description
Maintenance of weight loss
Time Frame
3 months follow-up
Title
Maintenance of weight loss 6 months follow-up
Description
Maintenance of weight loss
Time Frame
6 months follow-up
Title
Maintenance of weight loss 12 months follow-up
Description
Maintenance of weight loss
Time Frame
12 months follow-up
Secondary Outcome Measure Information:
Title
Adherence
Description
80% of completed website activities and 80% of self-records
Time Frame
4 months
Title
Drop out
Description
Percentage of participants who finish the treatment
Time Frame
4 months
Title
Quality of life test measures
Description
Questionnaire of Quality of Life provided by the LEARN program
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carmina Saldaña, PhD
Phone
+3493312125
Email
csaldana@ub.edu
Facility Information:
Facility Name
Unidad de Terapia de Conducta, University of Barcelona
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmina Saldaña, PhD
Phone
+34933125125
Email
csaldana@ub.edu
First Name & Middle Initial & Last Name & Degree
Carmen Varela, MsC
Phone
+34933125023
Email
carmenvarela@ub.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Research team have to meet and make a decision about this field
Citations:
PubMed Identifier
31752815
Citation
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.
Results Reference
derived

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

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