OverweightNCT04127201
En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity
A study testing en_línea and Group therapy in people with Overweight and Obesity, run by University of Barcelona at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- en_línea and Group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteSpain
- Study dates
- 12 Dec 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Unidad de Terapia de Conducta, University of Barcelona
Barcelona, 08035
Carmina Saldaña, PhD, +34933125125, csaldana@ub.edu
Carmen Varela, MsC, +34933125023, carmenvarela@ub.edu
About this study
Official title: 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
Read the 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.
- Conditions
- Overweight, Obesity
- Being tested
- en_línea, Group therapy
- Keywords
- "online therapy", "weight loss control program", Internet
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
en_líneaBehavioural
Also called Web-based weight control program
This is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004.
Group therapyBehavioural
This is a traditional behavioral weight control program
| Study group | Role | What they receive |
|---|---|---|
| Online intervention, en_línea | Experimental | 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. Receives: Behavioral: en_línea |
| Standard group therapy | Active comparator | 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. Receives: Behavioral: Group therapy |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
5%-10% of weight loss respect the initial weight
Measured: 4 months
Maintenance of weight loss 1 month follow-up
Maintenance of weight loss
Measured: 1 month follow-up
Maintenance of weight loss 3 months follow-up
Maintenance of weight loss
Measured: 3 months follow-up
Maintenance of weight loss 6 months follow-up
Maintenance of weight loss
Measured: 6 months follow-up
Maintenance of weight loss 12 months follow-up
Maintenance of weight loss
Measured: 12 months follow-up
Secondary outcomes (3)
Adherence
80% of completed website activities and 80% of self-records
Measured: 4 months
Drop out
Percentage of participants who finish the treatment
Measured: 4 months
Quality of life test measures
Questionnaire of Quality of Life provided by the LEARN program
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start12 Dec 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmina Saldaña, University of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127201
- Sponsor's protocol ID
- IRB00003099
- Status last verified
- Oct 2019
- First submitted
- 11 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Research team have to meet and make a decision about this field
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.
PubMed 31752815
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- En_Línea. An Online Treatment to Change Lifestyle in Overweight and Obesity: Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04127201
- Acronym / sponsor ID
- IRB00003099
- Conditions
- Overweight, Obesity
- Keywords
- "online therapy", "weight loss control program", Internet
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 305 participants (estimated)
- Lead sponsor
- University of BarcelonaUniversity, hospital or other
- Study start
- 12 Dec 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 15 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online intervention, en_línea | Experimental | Behavioral: en_líneaParticipants 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 comparator | Behavioral: Group therapyParticipants 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 intervention | –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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| en_líneaAlso: Web-based weight control programThis is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004. | Behavioural | Online intervention, en_línea |
| Group therapyThis is a traditional behavioral weight control program | Behavioural | Standard group therapy |
Primary outcome
Weight loss
Time frame: 4 months
5%-10% of weight loss respect the initial weight
Maintenance of weight loss 1 month follow-up
Time frame: 1 month follow-up
Maintenance of weight loss
Maintenance of weight loss 3 months follow-up
Time frame: 3 months follow-up
Maintenance of weight loss
Maintenance of weight loss 6 months follow-up
Time frame: 6 months follow-up
Maintenance of weight loss
Maintenance of weight loss 12 months follow-up
Time frame: 12 months follow-up
Maintenance of weight loss
3 secondary outcomes
Adherence
Time frame: 4 months
Drop out
Time frame: 4 months
Quality of life test measures
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- Derived from this study: PubMed 31752815Varela 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.
- Individual participant dataSharing planned: No. Research team have to meet and make a decision about this field
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing en_línea and Group therapy in people with Overweight and Obesity, run by University of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carmina Saldaña, PhD (+3493312125, csaldana@ub.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04127201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.