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
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: en_línea Behavioral: Group therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||305 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
- 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
- Adherence [ Time Frame: 4 months ]80% of completed website activities and 80% of self-records
- Drop out [ Time Frame: 4 months ]Percentage of participants who finish the treatment
- Quality of life test measures [ Time Frame: 4 months ]Questionnaire of Quality of Life provided by the LEARN program
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
|Contact: Carmina Saldaña, PhDfirstname.lastname@example.org|