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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| en_línea | Behavioral | This is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adherence | 80% of completed website activities and 80% of self-records | 4 months |
| Drop out | Percentage of participants who finish the treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carmina Saldaña, PhD | Contact | +3493312125 | csaldana@ub.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad de Terapia de Conducta, University of Barcelona | Recruiting | Barcelona | 08035 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31752815 | Derived | 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. |
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Research team have to meet and make a decision about this field
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D011615 | Psychotherapy, Group |
| ID | Term |
|---|---|
| D012960 | Socioenvironmental Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Group therapy | Behavioral | This is a traditional behavioral weight control program |
|
| 4 months |
| Quality of life test measures | Questionnaire of Quality of Life provided by the LEARN program | 4 months |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |