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| ID | Type | Description | Link |
|---|---|---|---|
| PI16/00170 | Other Grant/Funding Number | Instituto de San Carlos III | |
| GRS 1277/B/16 | Other Grant/Funding Number | Gerencia Regional de Salud de Castilla y León |
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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
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This is a randomized clinical trial aimed at obese and sedentary subjects aged 20 to 65 years selected in urban primary care centers of 5 centers (Spain). Its objective is to evaluate the effects of the addition of an ICT tool developed for the Smartphone application and a Smartband in support of behavioral and educational recommendations to reduce weight.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control: Lifestyle counseling | Active Comparator | Counseling on physical activity and nutrition. |
|
| Intervention group | Experimental | Add for three months a Smartphone with an app (EVIDENT III) and a Smartband to lose weight and improve physical activity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group | Other | Smartphone with APP (EVIDENT III) and a Smartband for 3 months. Counseling on physical activity and nutrition |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight reduction | Measurement by kilograms | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Increase steps/day | Steps/day by accelerometer | 1 year |
| Decrease sedestation minute week | Minutes week in sedentary activity by Activpal monitor |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Luis Garcia Ortiz, MD, PhD | Fundacion Infosalud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Research Unit - The Alamedilla Center for Health | Salamanca | 37006 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35103609 | Derived | Lugones-Sanchez C, Recio-Rodriguez JI, Agudo-Conde C, Repiso-Gento I, G Adalia E, Ramirez-Manent JI, Sanchez-Calavera MA, Rodriguez-Sanchez E, Gomez-Marcos MA, Garcia-Ortiz L; EVIDENT 3 Investigators. Long-term Effectiveness of a Smartphone App Combined With a Smart Band on Weight Loss, Physical Activity, and Caloric Intake in a Population With Overweight and Obesity (Evident 3 Study): Randomized Controlled Trial. J Med Internet Res. 2022 Feb 1;24(2):e30416. doi: 10.2196/30416. | |
| 35057451 |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D005247 | Feeding Behavior |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D001522 | Behavior, Animal |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
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| Control: Lifestyle counseling | Other | Conseling on physical activity and nutrition (intervention) |
|
| 1 year |
| Decrease total caloric intake/day | Calories/day by Food frecuency questionnaire | 1 year |
| Improve Quality of life | Measurement by IWQOL-L | 1 year |
| Augmentation index | Central and peripheral augmentation index | 1 year |
| Adiponectin | Inflammation marker | 1 year |
| Derived |
| Lugones-Sanchez C, Recio-Rodriguez JI, Menendez-Suarez M, Saz-Lara A, Ramirez-Manent JI, Sanchez-Calavera MA, Gomez-Sanchez L, Rodriguez-Sanchez E, Garcia-Ortiz L, Evident Investigators Group. Effect of a Multicomponent mHealth Intervention on the Composition of Diet in a Population with Overweight and Obesity-Randomized Clinical Trial EVIDENT 3. Nutrients. 2022 Jan 9;14(2):270. doi: 10.3390/nu14020270. |
| 33242020 | Derived | Lugones-Sanchez C, Sanchez-Calavera MA, Repiso-Gento I, Adalia EG, Ramirez-Manent JI, Agudo-Conde C, Rodriguez-Sanchez E, Gomez-Marcos MA, Recio-Rodriguez JI, Garcia-Ortiz L; EVIDENT 3 Investigators. Effectiveness of an mHealth Intervention Combining a Smartphone App and Smart Band on Body Composition in an Overweight and Obese Population: Randomized Controlled Trial (EVIDENT 3 Study). JMIR Mhealth Uhealth. 2020 Nov 26;8(11):e21771. doi: 10.2196/21771. |
| 29480874 | Derived | Recio-Rodriguez JI, Gomez-Marcos MA, Agudo-Conde C, Ramirez I, Gonzalez-Viejo N, Gomez-Arranz A, Salcedo-Aguilar F, Rodriguez-Sanchez E, Alonso-Dominguez R, Sanchez-Aguadero N, Gonzalez-Sanchez J, Garcia-Ortiz L; EVIDENT 3 investigators. EVIDENT 3 Study: A randomized, controlled clinical trial to reduce inactivity and caloric intake in sedentary and overweight or obese people using a smartphone application: Study protocol. Medicine (Baltimore). 2018 Jan;97(2):e9633. doi: 10.1097/MD.0000000000009633. |
| D010349 |
| Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |